blister packs that favor intuitive dosing

专利摘要:
BLISTER CARDS THAT ENJOY INTUITIVE DOSING The present invention relates to a blister card with the back side and a front side opposite to the back side. The front side has a plurality of blisters and each blister contains a unit dose and each unit dose contains an active ingredient. Each blister pack contains from about 12 hours to about 24 hours of unit doses according to the dosing instructions. The active ingredients can be the same or different.
公开号:BR112013013392B1
申请号:R112013013392-9
申请日:2011-12-16
公开日:2020-12-08
发明作者:Rosa Manuela Leon Alonso；Kelly Lee Schmeichel；Isabella La Fosse-Marin；Angela Jane Deutsch；Thomas Alfred Inglin；Kurt Franklin Trombley；Diane Danheiser Powers；Eduardo De Abreu Mangione；Craig Andrew Hawkins
申请人:The Procter & Gamble Company；
IPC主号:

专利说明:

TECHNICAL FIELD
[0001] The present invention is generally directed to blister packs, and more particularly, to blister packs that favor intuitive dosing. BACKGROUND OF THE INVENTION
[0002] With many treatment regimens, it is recommended to take different unit doses at different times of the day and / or on certain days. These dosages may require administration at different times of the day, or under different conditions such as, for example, on an empty stomach, or on a full stomach. In addition, when the unit dose should be administered at certain times of the day, remembering what time the unit dose should be taken can confuse the user. Patient compliance to treatment with these types of programs therefore becomes a problem.
[0003] Many types of packaging and kits have been developed for dispensing unit doses. These kits include those designed to dispense active ingredients on a continuous daily basis. See, for example, US patent No. 5,265,728, issued to Allendorf et al., Published on November 30, 1993; Publication EP 0 511726 A2, by Berlex Laboratories, Inc., published on November 4, 1992; PCT publication WO 99/51214, by Akzo Nobel, published on October 14, 1999; and US Patent No. 4,958,736, Urheim, issued November 25, 1990, which describes dispensers for the administration of various drugs including oral contraceptives with a continuous daily frequency including in regimes where the active ingredient is administered daily for approximately 21 days followed by placebo administration for about seven days. Other kits and dispensers have been developed, designed to administer multiple doses of the same active ingredient per day, or to administer, simultaneously or not, two or more active ingredients. See, for example, US patent No. 6,024,222, to Friberg et al., Issued on February 15, 2000; US patent No. 6,219,997, to Friberg et al., Issued April 24, 2001; U.S. patent publication 2003/0168376 A1, Taneja et al. published on September 11, 2003; U.S. patent publication 2003/0111479, Taneja et al., published June 19, 2003; US patent No. 6,375,956, to Hermelin et al., Issued April 23, 2002; PCT publication WO 88/02342, Astra Lakemedel Aktiebolag, published April 7, 1988; US patent No. 4,295,567, to Knudsen, issued October 20, 1981; DE 29719 070, by Byk Gulden Lomberg Chemische Fabrik, published June 25, 1998; US patent No. 5,848,976, to Weinstein, issued on 15, 1998; US patent No. 6,270,796, to Weinstein, issued August 7, 2001; US patent No. 6,564,945, to Weinstein et al., issued on May 20, 2003; and US patent no. 5,788,974, D'Amico et al., issued on August 4, 1998. A kit was also presented for the administration of an active ingredient with a frequency of once a week. See U.S. Pub. 2001/0044427, by Mazel et al., Published November 22, 2001. SUMMARY OF THE INVENTION
[0004] A blister card comprising: a back side; a front side opposite to the back side, the front side containing a plurality of blisters with each blister containing a unit dose, the unit doses containing an active ingredient; a manufacturing symbol visible on the front side; and dosing instructions; the blister pack containing about 12 hours to about 24 hours of unit dosage according to the dosing instructions. BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The following detailed description of specific embodiments of the present invention can be better understood when read in conjunction with the drawings included herein.
[0006] Figure 1 illustrates a modality of a unit dose dispensing system; Figure 2 illustrates a front view of an embodiment of a blister card for use with the unit dose dispensing system of Figure 1; Figure 3 is a side view of the blister card of Figure 2; Figure 4 is a sectional view of a blister region along line 4-4 of Figure 2; Figure 5 is a front view of the blister card of Figure 2 with the blister sheet removed; Figure 6 is another front view of the blister card of Figure 2 with the blister sheet removed; Figure 7 is a front view of an embodiment of a blister foil; Figure 8 is a rear view of the blister card of Figure 2; Figure 9 is another embodiment of a blister card; Figure 10 is a side view of the blister card of Figure 9; Figure 11 is a rear view of the blister card of Figure 9; Figure 12 is a front view of another embodiment of a blister card; Figure 13 is a front view of another embodiment of the blister card; Figure 14 is a front view of another embodiment of a blister card; Figure 15 is a front view of another embodiment of a blister card; and Figure 16 is a perspective view of another embodiment of the blister card.
[0007] The modalities presented in the drawings are illustrative in nature and are not intended to limit the invention defined by the claims. In addition, the individual characteristics of the drawings and the invention will become more apparent and fully understood in view of the detailed description. DETAILED DESCRIPTION
[0008] The present invention relates to a blister card capable of providing an intentional dosage. Intuitive dosing allows users to take their medications more easily at the correct time, which can ultimately allow the user to feel better throughout the day because he is taking his medication at the appropriate times.
[0009] The blister pack can contain doses for the whole day. The whole day can include twenty-four hours of active as indicated by the dosing instructions and can include daytime and nighttime doses. In another example, the whole day may include unit doses that are intended to be consumed during daytime hours. In one example, the blister pack contains doses for cold / flu MSR. Instructions on the front of the package that can include words, numbers, or icons, and communicate easily and clearly when the user should take their medication. Blister packs can contain a variety of assets including active ingredients for cold / flu MSR. The blister pack can be small and portable to allow users to put the blister pack in their pocket, bag, or briefcase and have access to medication during the day. Rounded corners can make the blister pack even more portable.
[00010] The following text provides a broad description of numerous different embodiments of the present invention. The description is intended to be interpreted as merely exemplary and does not describe all possible modalities, as this would be impractical, if not impossible, and it should be understood that any resource, characteristic, component, composition, ingredient, dosage, product, stage or The methodology described here can be totally or partially erased, combined with, or replaced by, any other resource, characteristic, component, composition, ingredient, product, stage or methodology described here. Numerous alternative modalities could be implemented, using the current technology or the technology developed after the date of filing this patent, which would still be within the scope of the claims. All publications and patents cited in the present invention are incorporated herein by reference.
[00011] It is to be understood that, unless a term is expressly defined in this specification using the sentence "For use in the present invention, the term '' is defined herein to mean ..." or a similar sentence , there is no intention to limit the meaning of this term, either expressly or by implication, in addition to its common or ordinary meaning, and such term should not be interpreted as a scope limiter based on any statement made in any section of this patent ( in addition to the language of the claims). No term is intended to be essential to the present invention, except when so stated. To the extent that any term recited in the claims at the end of this patent is mentioned in this patent in a manner consistent with a single meaning, this is done only for the sake of clarity so as not to confuse the reader, and there is no intention to that this claim term be limited, by implication or otherwise, to that one. Finally, unless a claim element is defined by mentioning the word "means" and a function without exposing any structure, the scope of any claim element is not intended to be interpreted based on the request of 35 USC § 112 , sixth paragraph.
[00012] "Blister packs" are for unit dose packaging. In general, blister packs typically include a front side, which is the side that includes one or more blisters and an opposite rear side through which the unit dose is removed from the blister. Blister cards can come in a variety of shapes such as rectangular, rounded as circular, etc.
[00013] A "face" of the blister card refers to one or more surfaces visible on the front side of the blister card.
[00014] The term "blister" refers to a wrapper formed by an external cover that is raised on the face thus forming a cavity to house a unit dose.
[00015] The term "regulatory information" refers broadly to information that needs to be provided with a product by a government agency, such as the US Food and Drug Administration (FDA). Regulatory information for unit doses may include information about ingredients; warnings, if any; dosing instructions; manufacturer or distributor name; lot number; expiration date; opening or access instructions (for example, for child resistant packaging); and a declaration of any evident counterfeiting characteristics.
[00016] The term "contiguous," as used here, means to be in real contact.
[00017] The term "daily" in the context of a unit-dose dispensing system described herein refers to the administration of multiple doses of the same or different ingredients within the same day or a 24-hour period. For example, a single blister pack for daily use may include multiple doses that must all be taken within the same 24-hour interval, as indicated by the package instructions. In another example, a single blister pack for daily use may include multiple doses that are all taken during the day as indicated by the package instructions. In one example, doses are taken over a period of 8 hours, in another example doses are taken over a period of 12 hours, in another example doses are taken over a period of 16 hours, in other examples doses are taken over a period of 18 hours, and in another example doses are taken over a period of 24 hours.
[00018] The term "unit dose" or "unit dose" means a dosage form that contains an amount of an active ingredient or nutrient suitable for administration in a single dose, in accordance with good medical practice.
[00019] As used herein, "active ingredient" includes all compounds and compositions that can be used to treat and / or prevent disease and / or provide general health and welfare benefits in mammals. Some non-limiting examples of particularly useful assets include over-the-counter and over-the-counter assets, vitamins, minerals, elements, plant-derived materials, energetic materials, probiotics, fibers, prebiotics, and combinations thereof. In one example, the active ingredient is an active ingredient for cold / flu MSR.
[00020] As used here, the term "daytime" means a unit dosage that is taken in general during the day. Daytime active ingredients may include unit doses of daytime cold / flu MSR. Daytime medication may comprise stimulants. In another example, daytime unit doses are not sedative. In one example, the daily unit dose may comprise phenylephrine or pseudophedrine.
[00021] As used here, the term "nocturnal" means a unit dosage that is generally taken around bedtime. Night medication may include cold MSR flu / night medication. Night unit doses may comprise sedatives. In another example, overnight unit doses do not contain stimulants. In one example, the nightly unit dose may comprise doxylamine succinate.
[00022] As used here, the term "instructions" provides information for a potential user or user of the systems, dosage units (for example, the active ingredient contained therein) and blister cards. Instructions can understand different forms and present information in different ways, in different types of media. Some non-limiting examples of instruction types include alphanumeric instructions, figures, drawings, illustrations, photos, computer generated images, colors, sounds, textures, formats, symbols, letters, numbers, and combinations thereof.
[00023] With reference to Figure 1, an exemplary embodiment of a unit dose dispensing system 10 includes a container 12 (e.g., a box) that houses multiple blister cards 14 therein. As an example, each blister pack 14 can include multiple unit doses 13 and 15 which should all be consumed on a daily basis (ie, over a 24-hour period). Thus, the blister cards 14 can be called daily blister cards. A user using the unit dose dispensing system 10 can remove a blister card 14 from the container 12 on a daily basis and carry the blister card 14 with him or her to self-administer the doses associated with the blister card 14.
[00024] In some examples, unit dose 13 may be different from unit dose 15. For example, unit dose 13 may contain or have a different active ingredient, different loading (for example, different amounts of an active ingredient), a different color, different marking, different size and / or different format of the unit dose 15. Unit doses 13, for example, can be administered during the day when sedation is not desired. Unit dose 15, for example, can be administered overnight when stimulation is not desired. Unit dose 13 may contain a non-sedating and / or decongestant antihistamine, but not a sedating antihistamine. Unit dose 15 may contain a sedating or non-sedating antihistamine, but not a nasal decongestant. In another example, both unit dose 13 and unit dose 15 may comprise more than one active ingredient and at least one active ingredient is different. Of course, other active ingredients are possible, some of which are presented below.
[00025] In another example, unit dose 13 and unit dose 15 may contain the same active ingredient and unit doses are intended to be consumed during the day. For example, the blister pack can contain three unit doses, one can be taken in the morning, another at noon, and another in the afternoon. The user can then take a different product, such as a liquid medication, if desired, at night.
[00026] Blister packs 14 may include information that helps a user to understand how (for example, when) to take unit doses 13 and 15 loaded by blister packs 14. Now with reference to Figures 2 and 3 showing blister pack 14 separately , the blister card 14 generally includes a front side 16 and a rear side 18 opposite the front side 16. With particular reference to Figure 2, the front side 16 includes a face 20 which is visible by the user having an external periphery 22. A total flat area of the front side 16 is defined by the outer periphery 22 (for example, width of the front side multiplied by the height of the front side for a rectangular blister card). A blister sheet 24 extends over at least a portion of face 20. In the illustrated embodiment, blister sheet 24 extends over only a portion of face 20, however in other embodiments, blister sheet 24 extends over only one larger portion of face 20 as all of face 20. Blister sheet 24 includes multiple visible blister regions 26, 28 and 30, each including a blister 34, 36 and 38 extending outwardly on face 20 and a shoulder region 42, 44 and 46 surrounding their respective blister 34, 36 and 38. Shoulder regions 42, 44 and 46 can be used to fix or attach blister sheet 24 to face 20. Each of the blisters 34, 36 and 38 form a cavity 50, 52 and 54 in which one or more unit doses (for example, in tablet form, capsule form, liquid form) can be maintained.
[00027] In some embodiments, each blister region 26, 28 and 30 may include an outline with perforated line 57 (or another line of weakness) that allows removal of the specific blister region 26, 28 and 30 from blister card 14. Notches 59 can be provided in the corners of the blister regions 26, 28 and 30, which can be used to round the corners so that a square and sharp corner is not provided, for example, when a blister region 26, 28 and 30 is torn from the carton blister 14. The notches 59 can also serve as a visual separation between the different blister regions 26, 28 and 30.
[00028] The front side 16 includes one or more primary instruction areas 58 and 60. In the embodiment of Figure 2, the primary instruction area 58 can be a primary manufacturer's instruction area and primary instruction area 60 can be a primary instruction area. primary unit dose instruction area. The primary area of the manufacturer 58 can extend continuously over the face 20 of the front side 16, can be without any blisters and unit doses and can include at least one indicator of the manufacturer 62, such as a logo, image, name of the manufacturer, etc. . to provide the user with an indicator of the manufacturer or origin of the blister card 14. In general, the term "primary manufacturer area" refers to the area of the face 20 surrounding the at least one indicator of the manufacturer 62 and not including a blister and unit dose.
[00029] The primary unit dose symbol area 60 may correspond to the area occupied on face 20 on the front side 16 near the visible blister regions 26, 28 and 30 of blister sheet 24. In some embodiments, the unit dose symbol area Primary 60 includes two or more instructional sub-areas of unit dose 64, 66 and 68. Each instructional sub-area of unit dose 64, 66 and 68 can be visible by the user and includes an instructional indicator (not shown in Figure 2) that indicates the period of day when the unit dose associated with the instructional sub-area of unit dose 64, 66 and 68 must be consumed.
[00030] In the embodiment of Figure 2, the blister card 14 has a long or horizontal axis A1 that extends along a width of the blister card 14 and a short or vertical axis A2 extending along a height of the blister card 14. The terms horizontal and vertical refer to when face 20 is in a vertical orientation with the manufacturer's indicator 62 in the illustrated vertical orientation. As can be seen, the primary manufacturer's instruction area 58 continuously extends from the primary unit dose area 60 along the height (i.e., in the direction of the vertical axis A2) to the top edge 72 of the outer periphery 22. The instruction area of the primary manufacturer 58 also extends continuously along the width (i.e., in the direction of the horizontal axis A1) between the lateral edges 74 and 76 of the outer periphery 22.
[00031] The primary unit dose instruction area 60 continuously extends from the primary manufacturer's instruction area 58 along the height (i.e., in the direction of the vertical axis A2) to a bottom edge 78 of the outer periphery 22. The instruction area for the primary unit dose 60 also extends continuously along the width (i.e., in the direction of the horizontal axis A1) between the lateral edges 74 and 76 of the outer periphery 22.
[00032] With reference to Figure 4, a sectional view of the blister card 14 including blister 34 is shown without the unit dose 13. In the illustrated embodiment, the blister card 14 includes a support layer 300, a breakable layer 302, the blister sheet 24 and a cover layer 304. In some embodiments, the backing layer 300 and the cover layer 304 can be formed from the same sheet of material that is folded at the top edge 72 (Figure 3) of the blister card 14 of so that the blister sheet 24 and the tearable layer 302 are at least partially pressed together. In other embodiments, the tear layer 302 and the blister sheet 24 may not be sandwiched between the backing layer 300 and the top layer 304.
[00033] The blister layer 34 includes an outer blister wall 79 that defines the cavity 50 between the outer blister wall 79 and a blister support surface 306 that is formed by the breakable layer 302. A shoulder 83 provides an outline where external blister wall 79 rises and is detached from the blister support surface 306. As seen in Figure 5, a projected cavity area 85 is bounded by the shoulder (represented by line 83) in places where the shoulder rises from the blister support surface 306. The projected cavity area is the projection area of cavity 50 on blister support surface 306 of blister card 14.
[00034] With reference to Figure 5, the blister card 14 is illustrated with the blister sheet 24 removed to illustrate face 20. Face 20 includes the instruction area of the primary manufacturer 58 which, in this embodiment, can be formed by the layer of cover 304 and the primary unit dose instruction area 60 which is contiguous with the primary manufacturer symbol area 58. The manufacturer indicator 62 is located within the primary manufacturer's instruction area 58. In some embodiments, the information or indication in addition to the manufacturer indicator 62 it can also be located in the symbol area of manufacturer 58.
[00035] Face 20 additionally includes the primary unit dose symbol area 60. The primary unit dose symbol area 60 is subdivided into multiple instructional unit dose sub areas 64, 66 and 68. In the modalities of Figure 5, the sub areas instructional unit doses 64, 66 and 68 each correspond to (for example, include about the same contour, location and dimensions that) a respective subarea of blister regions 26, 28 and 30 (Figure 2) where the adjacent visible blister regions 26, 28 and 30 are separated by a weakness line or tear line 57 (for example, a perforated marking line).
[00036] The projected cavity areas 85, 87 and 89 are located within the unit dose instructional subareas 64, 66 and 68. In some modalities, no more than about 45 percent of the total flat area bounded by the outer periphery 22 is covered by the projected cavity areas 85, 87 and 89. In some modalities, no more than about 40 percent of the total flat area bounded by the outer periphery 22 is covered by the projected cavity areas 85, 87 and 89, such as about 35 percent or less, like about 30 percent or less, like about 25 percent or less, like about 20 percent or less, like about 18 percent or less, like about 10 percent or less. In some modalities, the total flat area bounded by the outer periphery 22 may not be greater than about 120 cm2, as not greater than about 100 cm2, as not greater than about 80 cm2, as not greater than about 70 cm2, as not greater than about 61 cm2, as not greater than about 50 cm2.
[00037] In some embodiments, the blister card 14 which has an outer periphery shaped in a substantially rectangular manner, as seen in Figure 2, no more than about 36 percent of the total flat area bounded by the outer periphery 22 is covered by the areas of projected cavity 85, 87 and 89. For example, in some embodiments of a substantially rectangular blister card 14, no more than about 27 percent of the total flat area bounded by the outer periphery 22 is covered by the projected cavity areas 85, 87 and 89, as not more than about 18 percent. For other external periphery formats, as will be discussed below, these percentages may be different.
[00038] In some embodiment, the projected cavity areas 85, 87 and 89 may include only (that is, be bounded by or limited to only) a percentage of a planned dose projection area 310, 312 and 314. A " projected dose projection area "is the projection area for unit doses 13 and 15 projected onto the support surface of blister 306. In some embodiments, each projected cavity area 85, 87 and 89 cannot be greater than between about 100 percent to about 250 percent of its associated planned dose projection area 310, 312 and 314, as between about 100 percent to about 150 percent. In these modalities, the total projected cavity area (that is, the sum of the individual projected cavity areas) is only a percentage (for example, between about 100 percent to about 150 percent) of the dose projection area ( that is, the sum of the projected dose projection areas). For the purposes of these modalities, as an example for an oversized blister that has a projected total cavity area much larger than the projected dose projection area, the projected total cavity area includes only that area by about 100 percent and about 250 percent, as in about 100 percent to about 150 percent of the total projected dose projection area.
[00039] In some embodiments, a single blister can include only one unit dose as shown in Figure 2 or multiple unit doses as shown in Figure 9. In modalities that include only one unit dose in a blister, the projected cavity area may not be greater than between about 100 percent and about 150 percent of its associated projected dose projection area. In embodiments that include multiple unit doses in a blister, the projected cavity area may be no larger than between about 150 percent to about 250 percent of its associated projected dose projection area.
[00040] At least some or all of the unit dose instructional sub-areas 64, 66 and 68 include an instructional indicator 84, 86 and 88 that is visible through blister sheet 24 (for example, the blister sheet may be formed of a material transparent or translucent). In the example in Figure 5, each unit dose instructional subarea 64, 66 and 68 is of a different color as the instructional indicators 84, 86 and 88. In some modalities, the colors of unitary instructional subareas 64, 66 and 68 can be selected to provide a logical timing sequence that corresponds to different time periods of a day. For example, the instructional unit dose subarea 64 can be bright yellow to indicate a morning time period, the instructional unit dose subarea 66 can be yellow-orange to indicate the afternoon or evening period and the instructional unit dose subarea 68 can be blue to indicate a night time period.
[00041] In one example, unit doses 13 and 15 (Figure 1) can be of different colors to provide another instructional indicator for each instructional sub-area of unit dose 64, 66 and 68. For example, unit doses 13 can each be yellow and / or yellow-orange to indicate a daytime period and the unit dose 15 can be blue to indicate a nighttime period. Other color combinations are possible.
[00042] Each unit dose instruction subarea 64, 66 and 68 is contiguous with an adjacent unit dose instruction subarea 64, 66 and 68. In some embodiments, at least some or all unit dose subarea instruction 64, 66 and 68 have a clear outline defined between the instructional sub-areas of adjacent unit dose 64, 66 and 68. In these modalities where an instructional sub-area of unit dose 64, 66 and 68 is marked by a defined outline or abrupt change of color, the instructional sub-areas of dose unit 64, 66 and 68 can be called the discrete (that is, distinct unit dose) instructional subarea 64, 66 and 68.
[00043] With reference to Figure 6, in addition to color, the unit dose instruction subareas 64, 66 and 68 may include other instructional indicators 92 and 94. For example, instructional indicators 92 may be an image of the sun indicating a daytime period and an instructional indicator 94 can be an image of the moon indicating the night time period. The instructional indicator 92 of the sun can be located completely or at least partially in each of the instructional subareas 64, 66 and 68, while the instructional indicator 94 can be located completely or at least partially in an instructional subarea of unit dose 68. The instructional indicators 92 and 94 can also be seen through blister sheet 24 and, in some modalities, through blisters 34, 36 and 38.
[00044] In addition to images of the sun and moon, other instructional indicators may include text, such as "Morning," "Noon", "Afternoon," "Nightfall," and "Night" or other equivalent language. In some examples, instructional indicators may include other types of images such as a clock. In one example, periods of the day can also be associated with each instructional sub-area of unit dose 64, 66 and 68.
[00045] In some embodiments, instructional indicators can be arranged in a sequentially directional dosing arrangement. The term "sequentially directional dosing arrangement" refers to unit doses that are arranged in the blister card directionally (for example, from left to right) in a successive order according to the time of day to be consumed. For example, the sequentially directional dosing arrangement can provide a timing arrangement counterclockwise and from left to right, where the leftmost blisters are accessed first for the removal of unit doses. In another example, the sequentially directional dosing arrangement can provide a right-to-left and clockwise timing arrangement where the rightmost blisters are accessed first to remove the unit doses. Other arrangements can be employed as sequentially directional dosing arrangements from top to bottom and from bottom to top.
[00046] Now with reference to Figure 7, the blister sheet 24 is illustrated in isolation. Blister sheet 24 includes blister regions 26, 28 and 30 that are separated by lines of weakness 57. Each blister region 26, 28 and 30 includes one of blisters 34, 36 and 38 and one of shoulder regions 42, 44 and 46. The blister sheet 24 can be directly connected to the tear-off layer 302 (Figure 4) within shoulder regions 42, 44 and 46. In some embodiments, each blister 34, 36, 38 may have a vertical axis L1 and an axis horizontal L2, for example, to hold the capsule-shaped lengths (oval). The vertical axes L1 of blisters 34, 36 and 38 can be aligned substantially parallel to the vertical axis A2 of the blister card 14, where the horizontal axes L2 can be aligned substantially parallel to the horizontal axis A1 of the blister card 14. In others modalities, the vertical axes L1 of the blisters 34, 36 and 38 can be moved angularly both from the horizontal axis and from the vertical axis A1 and A2 of the blister card 14.
[00047] With reference to Figure 8, the back side 18 of the blister card 14 is illustrated where the blister card 14 is moved around its horizontal axis A1. The instructional symbol 96 is printed and visible on the back of the blister card 14. The instructional symbol 96 may include regulatory information, dosage details, ingredients, manufacturer information, warnings, etc. The instructional symbol 96 including regulatory information can belong to any or all of the unit doses within the unit dose instruction subareas 64, 66 and 68 (Figure 5). The instructional symbol 96 including any regulatory information can be located so that the regulatory information is not damaged when a unit dose is removed from at least one of the three blisters via the rear side 18.
[00048] Instructions 97, 99 and 101 can also be present on the back side of each of the unit dose instructional subareas 64, 66 and 68. In some embodiments, instructional signs 97, 99 and 101 can be located on the back side 18 to maintain a spatial orientation with the instructional unit dose subareas 64, 66 and 68 on the front side 16 so that, for example, instructions 97 are associated with the instructional unit dose subarea 64, the instructional symbol 99 is associated with the subarea instructional unit dose 66 and instruction 101 is associated with instructional unit dose subarea 68. Maintaining this spatial orientation can allow instructions 97, 99 and 101 associated with each unit dose 13 and 15 to be dragged along with its instructional subarea 64, 66 and 68 of associated unit dose when removed from the blister pack 14. This spatial arrangement can also leave enough regulatory information behind the blister pack 14 to comply with reg minimum regulations provided by a specific jurisdiction, such as the United States Food and Drug Administration. In some embodiments, instructions 97, 99 and 101 may include a representation of the instructional sub-areas of unit dose 64, 66 and 68 on the front side 16, which can assist in accessing the unit dose intended for a specific time period of the day. In some embodiments, for example, area 103 may be a door or flap 105 that can be opened or removed to expose the tearable layer 302 for removal of the unit dose.
[00049] As can be seen, instructions 96, 97, 99 and 101 are turned upside down in relation to the orientation of the manufacturer's indicator 62 (Figure 5). This can encourage the user, when viewing the front side 16, to turn the blister card 14 around its A1 axis to read the instructions 96 on the back side 18. In some embodiments, the instructions can also be turned from the left to the right or from right to left to encourage the user to turn the blister pack around its A2 vertical axis.
[00050] The blister card 14 described above is somewhat rectangular in shape with the unit dose instructional subareas 64, 66 and 68 being continuous and aligned along a substantially linear common outline, however, other shapes and arrangements are possible. Referring to Figure 9, a circular or rounded blister card 100 includes multiple unit doses 102, 104 and 106 that must all be consumed daily (that is, over a 24-hour period). As mentioned above, the blister pack 100 includes information that helps the user to understand how and when to take the unit dose loaded by the blister pack 100.
[00051] With reference to Figures 10 and 11, the blister card 100 includes a front side 108 and a back side 110 opposite the front side 108. The front side 108 includes a face 112 that has a substantially circular outer periphery 114 and an area total plane which is bounded by the outer periphery 114. A blister card 116 extends over at least a portion of face 112. Blister sheet 116 includes multiple visible blister regions 118, 120 and 122, each including a blister 124, 126 and 128 extending outwardly from face 112 and a shoulder region 130, 132 and 134 surrounding its respective blister 124, 126 and 128. Shoulder regions 130, 132 and 134 can be used to secure blister sheet 116 to the breakable layer similar to that shown in Figure 4. Blisters 124, 126 and 128 each form a cavity 136, 138 and 140 in which one or more unit doses (e.g., tablet, capsule, liquid) can be maintained.
[00052] In some embodiments, each blister region 118, 120 and 122 may include a perforated contour 142 (or another line of weakness) that allows removal of the particular blister region 118, 120 and 122 from the blister card 100. Notches 144 can be supplied in the corners of the blister regions 118, 120 and 122, which can be used to round the corners so that a relatively square and sharp corner is not provided.
[00053] In a similar manner to that described above, front side 108 includes two or more primary instruction areas 146 and 148. Primary instruction area 146 is the manufacturer's primary instruction area and primary instruction area 148 is one primary unit dose instruction area. The primary manufacturer's area 146 may extend continuously over the face 112 on the front side 108, may not have any blister and the unit dose may include at least one indicator of the manufacturer 153, such as a logo, manufacturer's name, etc. to provide the user with an indicator of the manufacturer or origin of the blister card 100.
[00054] The primary unit dose instruction area 148 can correspond to the area occupied on face 112 on the front side 108 by the visible blister regions 118, 120 and 122 of blister sheet 116. In some embodiments, the primary unit dose instruction area 148 includes two or more unit dose instructional subareas 152, 154 and 156. Each unit dose instructional subarea 152, 154 and 156 can be visible to the user and includes an instructional indicator 158, 160 and 162 that indicates a period of the day when the unit dose associated with the instructional unit dose subarea 158, 160 and 162 should be consumed in a manner similar to that described above including colors, images, numbers and text.
[00055] In some embodiments, the blister card 100 which has an outer periphery in a substantially circular shape, as seen in Figure 9, no more than about 40 percent of the total flat area bounded by the outer periphery 114 is covered by the cavity areas projected from blisters 124, 126 and 128. For example, in some embodiments of a substantially circular blister card 100, no more than about 28 percent of the total flat area bounded by the outer periphery 114 is covered by the projected cavity areas, as not more than about 18 percent.
[00056] The blister card 100, being circular, has a horizontal axis A1 that extends along a width of the blister card 100 and a vertical axis A2 that extends along a height of the blister card 100. Axes A1 and A2 correspond to a blister card diameter 100. The terms horizontal and vertical are used to refer to face 112 when it is in a vertical orientation with the manufacturer's indicator 153 in the vertical orientation shown. The primary manufacturer's instruction area 146 continuously extends from the primary unit dose area 148 along the height (i.e., in the direction of the vertical axis A2) to an upper portion 164 of the round outer periphery 114. The instruction area of the Primary manufacturer 150 also extends continuously along the width (i.e., in the direction of the horizontal axis A1).
[00057] The primary unit dose instruction area 148 extends continuously from the primary manufacturer's instruction area 146 along the height (i.e., in the direction of the vertical axis A2) to a lower portion 166 of the outer periphery 114 The primary unit dose instruction area 148 also extends continuously along the width (i.e., in the direction of the horizontal axis A1).
[00058] With reference to Figure 11, the rear side 110 of the blister card 100 is illustrated where the blister card 100 is turned around its horizontal axis A1. Instructions 168 are printed and visible on the back side 110 of blister card 100. Instructions 168 may include regulatory information, dosage details, ingredients, manufacturer information, warnings, etc. Instructions 168 including regulatory information may belong to any or all of the unit doses within the unit dose instruction subareas 152, 154 and 156. Instruction symbol 168 including any regulatory information can be located so that regulatory information is not damaged when a unit dose is removed from at least one of the three blisters via the rear side 110. As above, instructions 169, 171 and 173 can also be present on the rear side of each of the unit dose instructional sub-areas 152, 154 and 156 to maintain a spatial orientation with the unit dose instructional subareas 152, 154 and 156 on the front side 108. Instructions 168, 169, 171 and 173 can also be turned in relation to the orientation of the manufacturer's indicator 153 to encourage the user when visualizes the front side 110, turning the blister card 100 around its horizontal axis A1 or vertical axis A2 to read the instructions .
[00059] In some embodiments, such as those described above, the unit dose may be in the form of vertically oriented tablets. In the embodiment of Figure 2, only one tablet 13 or 15 is illustrated per blister. In Figure 9, more than one tablet 102, 104 and / or 106 (e.g., two tablets) are illustrated by blister and arranged vertically (i.e., parallel to the A2 axis). In some embodiments, there may be more than three blisters, such as no less than four to no more than five blisters per blister card. Referring to Figure 12, in an alternative embodiment, tablets 102, 104 and / or 106 can be arranged vertically offset, but include many of the features described above.
[00060] Referring to Figure 13, another type of blister card 180 includes a frangible portion 182 that can be separated along a line of weakness 184 to form a round blister card 180 similar to or equal to blister card 100. In these modalities, the calculation of the total flat area bounded by the outer periphery may include the frangible portion 182. In another embodiment 14, the blister regions 186, 188 and 190 of the blister card 192 can be arranged vertically. With reference to Figure 15, in yet another embodiment, the blister regions 194 and 196 of the blister card 198 can be separated from the blister region 201. Foldable blister cards can also be provided. Referring to Figure 16, a blister card 200 may include a fold line 202 which is formed on a formed and / or back side 204 and 206 of blister card 200, which allows blister card 200 to fold in a similar manner to book. In these modalities, the calculation of the total frangible area bounded by the outer periphery can be calculated using the unfolded state of the blister card 200. In these modalities, no more than about 15 percent of the total flat area bounded by the outer periphery can be covered by cavity areas designed by a 200 foldable blister card.
[00061] In general, the systems described above are directed to a blister pack, blister pack or blister foil, all used interchangeably. Blister packs can be of varying shapes and sizes, as desired based on the number, size and type of dosage units contained therein, and can be sized to be conveniently portable. Some non-limiting examples of some shapes include circular, round, oval, rectangular, square, triangular, trapezoidal, octagonal, and combinations thereof. It has been found that users, particularly men, prefer a blister pack with rounded corners because these blister packs are more comfortable to carry in the pockets of clothing. Therefore, the blister cards of the present invention may have rounded corners or be circular in shape. In one example, the blister card is rectangular with rounded corners. In addition, users, particularly women, preferred an exclusive format, such as a circular blister card, because it would be easier for them to find it in their purse or travel bag. The blister cards can also be formed to have means that allow the separation of one or more portions of the blister cards, that is, one or more portions containing a wrapper. Non-limiting examples of such media include perforations, markings and combinations thereof.
[00062] The blister card can be any size. It has been found that users prefer a small blister card that is more easily transportable. In one embodiment, the blister pack is portable and can easily fit into a purse, wallet, or pocket. For example, the blister card can be about 50 mm to about 120 mm wide, about 60 mm to about 100 mm wide, and about 65 mm to about 95 mm wide, and about 30 mm to about 100 mm in height, about 40 mm to about 90 mm in height, about 50 mm to about 80 mm in height, and from about 60 mm to about 70 mm in height height. In another embodiment, the blister card can be from about 50 mm to about 150 mm wide, from about 70 mm to about 130 mm wide, from about 90 mm to about 120 mm wide, and about from 40 mm to about 120 mm in height, from about 50 mm to about 180 mm in height, and from about 65 mm to about 140 mm in height. In another example, the blister card can be from about 20 mm to about 90 mm wide, in another embodiment from about 30 mm to about 70 mm wide, and in another embodiment from about 40 mm to about 60 mm wide, and about 20 mm to about 90 mm high, in another embodiment of about 30 mm to about 70 mm in height, and in another embodiment of about 40 mm to about 60 mm of height.
[00063] Blister packs can include one or more blister sheets on the front sides and a tear-off layer on the back sides, the combination of which contains one or more dosage units. The blister sheet provides envelopes, in any suitable size and / or shape, for one or more dosage units of any suitable size, shape or shape. The tear-off layer allows the dosing unit to be removed from the blister pack. The tear-away layer can be formed by all or a portion of the blister foil. The tear-off layer can be affixed to the blister sheet by applying heat and pressure or by adhesive, as examples. Such blister cards may also comprise a backing layer that can be arranged on or over the breakable layer, to prevent rupture and involuntary release of the dosing units. Such a backing layer can be peeled off to expose the breakable layer when the release of a dosage unit is desired. Such support layers can be formed over all or a portion of the breakable layer. Such a backing layer can be attached to the breakable layer and / or the blister layer using, for example, an adhesive.
[00064] Blister layers can be produced from a variety of suitable materials, the non-limiting examples of which include, thermoplastic materials, polyolefins, glycol modified polyethylene terephthalate (PETG), and combinations thereof. The blister sheet may be partially opaque or transparent and may be colorless or colored.
[00065] Breakable layers can be produced from a variety of suitable materials, some non-limiting examples of which include metal laminate, tempered metal laminate, cardboard, polyvinyl chloride, polyolefins, polystyrenes, polyesters, fluoropolymer resins, and combinations thereof. The breakable layer can also be formed as a laminate composed of a plurality of laminated layers of different materials, as long as its basic operation and breaking ability are not affected. The tear-off layer can be any desired color.
[00066] The backing layers can be produced from a variety of suitable materials, some non-limiting examples of which include paper, plastic, polyvinyl chloride, and combinations thereof. The support layer can be of any desired color. In some instances, blister cards may include features resistant to children or tampering. And in another example, the blister pack is resistant to children by North American standards. North American standards for child resistant packaging can be found in the Code of Federal Regulations, Title 16: Part 1700.
[00067] Blister cards can include any number of blisters and unit doses. In one example, the blister pack includes about 24 hours of unit doses, according to the dosing instructions, in another example the blister pack includes about 16 hours of unit doses, according to the dosing instructions, and in another For example, the blister pack includes about 12 hours of unit doses according to the dosing instructions. In one example, the blister pack may contain only medication intended for the daytime period, for example, the pack may contain three daily unit doses of cold / flu MSR.
[00068] Each blister can have a unit dose or a plurality of unit doses. In one example, each blister can have a unit dose, in another example the blister can comprise two unit doses, and in another embodiment each blister can have more than 2 unit doses. In one example, the carton may have 1 blister, in another example 2 blisters, and in another example 3 blisters, in another example 4 blisters, and in another example 5 blisters. Each blister can contain a unit dose. In one example, each blister can contain 1 tablet, in another example each blister can contain 2 tablets, and in another example each blister can contain more than 2 tablets.
[00069] It has been found that users prefer no more than five unit doses for twenty-four hours of treatment. In one example, the blister card can contain 5 unit doses, in another example 4 unit doses, in another example 3 unit doses, and in another example 2 unit doses. The unit dose can have the same composition or a different composition. In one example there may be 3 unit doses all with active ingredients for colds / flu daytime MSR. In another example, there may be 2 unit doses all with active MSR for daytime cold / flu. In another example, there may be 4 unit doses and 3 unit doses that are active for daytime cold / flu MSR and 1 dose that is for nighttime cold / flu active ingredients.
[00070] The blister card can be packed with other blister cards as in Figure 1 or it can be packed with other items. In one example, the kit may comprise a first blister pack and a second blister pack, the first blister pack may contain a first active ingredient and the second pack may contain a second active ingredient and the first active ingredient and the second active ingredient may be many different. In one example, the first active ingredient may consist of active ingredients for daytime MSR cold / flu a second active ingredient may be active ingredients for nighttime MSR cold / flu. In another example, the first blister pack can comprise from about 12 hours to about 16 hours of active ingredients according to the dosing instructions and the second blister pack can contain one or more unit doses of night active ingredients.
[00071] In another example, the kit may comprise a blister pack and liquid unit doses. The blister card can comprise from about 12 hours to about 16 hours of active ingredients according to the dosing instructions and the liquid unit doses can comprise a different active ingredient, for example, an active ingredient that is intended to be taken at night, as a dose for colds / flu MRS night. In another example, the kit may comprise more than one blister card.
[00072] The active ingredients carried by the blister cards can be selected from the following non-limiting list of active ingredients: pharmaceutical active ingredients without a prescription, pharmaceutical active ingredients with a prescription, vitamins, minerals, elements, derived materials plants, energetic materials, probiotics, fibers, prebiotics, and combinations thereof. Such active ingredients are generally grouped below, for ease of presentation, but as would be understood by those skilled in the art, there is overlap in the use of many of the active ingredients described here - for example, such active ingredients as anti-inflammatories and / or analgesic actives that can be used for respiratory conditions, gastrointestinal conditions, muscle and joint conditions, menstrual conditions and the like. When used in systems, methods and cards, the prescription active ingredients can be administered according to a prescribed regimen and can be combined into a system or kit with additional active ingredients, sold without a prescription.
[00073] The dosage units and systems of the present invention can comprise one or more active ingredients useful for treating a respiratory condition. Respiratory conditions cover a wide range of conditions, including viral infections like colds and flu, bacterial infections, as well as allergies, sinusitis, rhinitis, and the like. Respiratory conditions can present any of a variety of symptoms, such as runny nose, nasal and / or chest congestion, coughing, sneezing, pressure, headaches, muscle pain, fever, fatigue and / or sore throat. Active ingredients typically used to treat these symptoms generally fall into the following classifications: decongestants, anticholinergics, expectorants, antihistamines, antitussives, analgesics, antivirals, mucolytics, demulcents, anesthetics, and antibiotics. Such active ingredients may include over-the-counter pharmaceutical active ingredients and over-the-counter pharmaceutical active ingredients.
[00074] Dosage units for the treatment of respiratory symptoms associated with respiratory conditions can be manufactured in numerous product forms. Some non-limiting examples of the most common include tablets, pills, capsules, gel capsules, capsules filled with solid material, capsules filled with liquid, enteric coated forms, forms with prolonged release, solid tablets, liquid filled tablets, tablets for mouth and throat, chewing gum, confectionery, "gummy candies", effervescent tablets, dry dissolvable powders (for example, in sachets or thin packages), dissolvable strips, sublingual tablets, oral tablets, syrups, elixirs and liquids for ingestion, sweets, cookies, plasters for transdermal administration of an active ingredient, topical microbicidal compositions, as well as inhalants, topical creams and lotions that release volatile agents that are inhaled through the nose into the respiratory tract, and combinations thereof. Oral compositions are typically swallowed immediately, or slowly dissolved in the mouth.
[00075] Such dosage units can be prepared by any known technique or, otherwise, effective, as would be understood by those skilled in the art.
[00076] Some non-limiting examples of over-the-counter pharmaceutical active ingredients and over-the-counter pharmaceutical active ingredients suitable for use with respiratory conditions include: decongestants, some non-limiting examples of which include pseudoephedrine, phenylephrine, phenylpropanolamine, oxymetazoline , xylometazoline, naphazoline, 1-deoxiefedrine, ephedrine, propylhexedrine, and combinations thereof; anticholinergics, some non-limiting examples of which include ipratropium, chlorpheniramine, brompheniramine, diphenhydramine, doxylamine, clemastine, triprolidine, and combinations thereof; expectorants, some non-limiting examples of which include guaifenesin, ambroxol, bromhexine, and combinations thereof; antihistamines, some non-limiting examples include chlorpheniramine, desloratadine, levocetirizine, diphenhydramine, doxylamine, triprolidine, clemastine, pheniramine, brompheniramine, dexbrompheniramine, loratadine, cetirizine and fexofenylamine, boxamine, amine, derivatives, amyxamine, amine derivatives, alkoxamine , ketotifen, nedocromil, omalizumab, dimethinden, oxatomide, pemirolast, pyrrobutamine, pentigetide, tenaldin, picumast, tolpropamine, ramatroban, repirinast, suplatast tosylate aminoalkylester, tazanolast, bromodiphenylamine, tramadine, triloxamine, triloxamine, trilaminamine, trilaminamine , moxastin, orphenadrine, phenyltoloxamine, setastine, ethylenediamine derivatives, chloropyramine, chloroten, metapyrilene, pyrilamine, talastine, tenildiamine, tonzilamine hydrochloride, tripelinen, piperazine, chlorcycline, clocinizine, promethazine, tricochyzazine, hydroxychazine a methylsulfate, azatadine, cyproheptadine, deptropin, desloratadine, isotipendil, olopatadine, rupatadine, antazoline, astemizole, azelastine, bepotastine, clemizole, ebastine, emedastine, epinastine, levocabastine, mizamine, trindle, mizamine, combination of these; antitussives (cough inhibitors), some non-limiting examples of which include dextromethorphan, menthol, codeine, clofedianol, levodropropizine, and combinations thereof, analgesics, inflammatory and antipyretics, with some non-limiting examples of these including acetaminophen, ibuprofen, ketoprofen, diclofenac, naxoprene, aspirin, and combinations thereof, as well as prescription painkillers, some non-limiting examples of which include propoxyphene HCl, codeine, meperidine and combinations thereof, antivirals, some non-limiting examples of which include amantidine , rimantidine, pleconaryl, zanamivir, oseltamivir, and combinations thereof; mucolytics, some non-limiting examples of which include ambroxol, N-acetylcysteine, and combinations thereof; demulcent, some non-limiting examples of which include glycerin, honey, pectin, gelatin, Indian rhubarb peel, liquid sugar, glycyrrhizin (licorice) and combinations thereof; anesthetics, some non-limiting examples of which include phenol, menthol, diclonin HCl, benzocaine, lidocaine, hexylresorcinol, and combinations thereof; antibiotics, some non-limiting examples of which include nitroimidazole antibiotics, tetracyclines, penicillin-based antibiotics such as amoxicillin, cephalosporins, carbopenemas, aminoglycosides, macrolide antibiotics, lincosamide antibiotics, 4-quinolones, fluoroquinolones, rifamycin, fluoroquinolones, rifamycins, and rifamycin, themselves, and any pharmaceutically acceptable salts, metabolites, and combinations thereof of the active ingredients listed above.
[00077] In one example, dosage units are cold / flu MSR units that can comprise one or more cold / flu active ingredients and can be used to treat one or more cold / flu symptoms.
[00078] Cold / flu symptoms can be selected from the group consisting of nasal / sinus congestion, runny nose, sneezing, headache, dry cough, sore throat, sinus pressure or pain, chest congestion, continuous muscle pain or no, wet / chest cough, fever and combinations thereof.
[00079] The active ingredients of cold / flu can include decongestants, expectorants, antitussive antihistamines, analgesics, and combinations thereof. In one example, the decongestant is selected from the group consisting of pseudoephedrine, phenylephrine, and combinations thereof. In one example, the expectorant may be guaifenesin. In one example, the antihistamine can be chlorpheniramine. In one example, the antitussive may be selected from the group consisting of dextromethorphan, codeine, and combinations thereof. In one example, analgesics, anti-inflammatories and pain-relieving agents may include acetaminophen, ibuprofen, or combinations thereof. In one example, the dosage unit for cold / flu, in particular the daytime formulation, may additionally comprise caffeine, which is a stimulant.
[00080] In one example, the dosage units comprise one or more active ingredients for cold / flu, in another example the dosage units comprise two or more active ingredients for cold / flu, in another example the dosage units comprise three or more active ingredients for cold / flu, and in other examples of dosage units comprise four or more active ingredients for cold / flu. In one example, the dosage unit comprises exactly one active ingredient for cold / flu, in another example exactly two active ingredients for cold / flu, in another example exactly three active ingredients for cold / flu, and in another example exactly four active principles for cold / flu. In another example, the dosage units comprise acetaminophen, dextromethorpan, and phenylephrine.
[00081] The dosage units of the present invention can comprise from about 0% to about 90%, alternatively from about 0.0001% to about 75%, alternatively from about 0.001% to about 50%, alternatively from about 0.01% to about 25%, alternatively from about 0.01% to about 15%, and alternatively from about 0.01% and 10% of respiratory active ingredient or active ingredient for cold / flu by weight of the composition that forms the dosage unit.
[00082] Dosage units may comprise from about 0.001 milligram (mg) to about 1000 mg, alternatively from about 2.5 mg to about 750 mg, and alternatively from about 5 mg to about 650 mg of respiratory active ingredient or active ingredient for cold / flu, per dosage unit. In one example, the dosage units may comprise from about 100 mg to about 700 mg of analgesic, anti-inflammatory and pain relieving agent, and another example from about 200 mg to about 600 mg, and in another example of about 275 mg to about 550 mg, per dosage unit. In another example, the dosage units may comprise from about 2 mg to about 15 mg of anti-cough, in another example about 4 mg to about 14 mg, and in another example from about 7 mg to about 12 mg per dosage unit. In another example, the dosage units may comprise from about 50 mg to about 400 mg of expectorant, in another example about 75 mg to about 300 mg, and in another example from about 150 mg to about 250 mg per dosage unit. In another example, the dosage units may comprise from about 1 mg to about 10 mg of decongestant, in another embodiment from about 3 mg to about 8 mg, and in another embodiment from about 4 mg to about 6 mg , per dosage unit.
[00083] Dosage units may also comprise other active ingredients useful for treating respiratory conditions, some non-limiting examples of which include vitamins, minerals, elements, plant-derived materials, energetic materials, probiotics, fibers, prebiotics, and combinations of themselves. Such other active ingredients are described below.
[00084] Dosage units can be administered in a single daily dose, or in multiple daily doses.
[00085] The dosage units and systems of the present invention may comprise one or more active ingredients useful for treating a gastrointestinal condition. Gastrointestinal conditions cover a wide range of conditions, including viral infections, bacterial infections, autoimmune conditions, genetic conditions and the like. Gastrointestinal conditions can present any of a variety of symptoms, associated with a disturbance in the function of the digestive system, such as diarrhea, constipation, stomach upset, vomiting, stomach heartburn, colic, gas, bloating, stomach pain, and the like. Active ingredients typically used to treat these symptoms generally fall into the following classifications: laxatives, antidiarrheals, antiemetics, anti-inflammatories, antacids, RAFT mechanism agents and antiflatulents. Such active ingredients may be over-the-counter pharmaceutical active ingredients and over-the-counter pharmaceutical active ingredients.
[00086] Dosage units for the treatment of gastrointestinal symptoms associated with gastrointestinal conditions can be manufactured in numerous product forms, some non-limiting examples of the most common ones include tablets, pills, capsules, gel capsules, capsules filled with solid material, capsules liquid filled, enteric coated forms, prolonged release forms, solid tablets, liquid filled tablets, mouth and throat tablets, chewing gum, confectionery, "gummy candies", effervescent tablets, dry dissolving powders, dissolvable strips , sublingual tablets, oral tablets, syrups, elixirs and liquids for ingestion, plasters for transdermal administration of an active ingredient, sweets, cookies, suppositories, as well as topical creams and lotions that release agents that are absorbed into and through the skin and / or mucous membranes into the gastrointestinal tract, and combinations thereof.
[00087] Some non-limiting examples of over-the-counter and prescription pharmaceutical active ingredients suitable for use with gastrointestinal conditions include: antidiarrheals, non-limiting examples of which include loperamide, compositions containing bismuth, subsalicylate, colloidal bismuth subcitrate , bismuth subcitrate, kaolin, pectin, clays such as atapulgite, activated carbon, and combinations thereof; laxatives, some non-limiting examples of which include fiber, resistant starch, resistant maltodextrin, pectin, cellulose, modified cellulose, polycarbophil, senna, senosides, bisacodyl, sodium phosphate, docusate, magnesium citrate, mineral oil, glycerin, aloe, castor oil, magnesium hydroxide, and combinations thereof, anti-nauseating and anti-emetic, some non-limiting examples of which include compositions containing bismuth, phosphate carbohydrates, diphenhydramine, cyclizine, meclizine, and combinations thereof; antacids, some non-limiting examples of which include sodium bicarbonate, sodium carbonate, calcium carbonate, magnesium carbonate, magnesium hydroxide, aluminum hydroxide, magnesium silicates, alginic acids, sodium alginate, magaldrate, and combinations of themselves; antiflatulent / antigen, non-limiting examples of which include simethicone, activated carbon, lactase, alpha-galactosidase enzymes, and combinations thereof; H2 receptor antagonists, some non-limiting examples of which include famotidine, ranitidine, cimetidine, nizatidine, and combinations thereof; proton pump inhibitors, some non-limiting examples of which include omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole, and combinations thereof, anti-inflammatories, some non-limiting examples of which include mesalamine, and any pharmaceutically acceptable salts, metabolites , and combinations thereof. non-limiting examples of RAFT mechanism agents include alginates; pectins and polysaccharides, and combinations of the same active ingredients mentioned above.
[00088] Dosage units may comprise from about 0.001% to about 99%, alternatively from about 0.01% to about 99%, alternatively from about 0.1% to about 99%, alternatively from about 1% to about 99%, and, alternatively, from about 5% to about 95% of pharmaceutical active ingredient sold without a prescription or sold with a prescription, based on the total weight of the composition that forms the dosing unit.
[00089] Dosage units may comprise from about 0.001 mg to about 5 g, alternatively from 0.01 mg to about 2 g, alternatively from 0.1 mg to about 1000 mg, and alternatively, from about 1 mg to about 1000 mg of pharmaceutical active ingredient sold without a prescription or sold with a prescription, per dosage unit.
[00090] Dosage units may also comprise other active ingredients useful for treating gastrointestinal conditions, some non-limiting examples of which include vitamins, minerals, elements, plant-derived materials, energetic materials, probiotics, fibers, prebiotics, and combinations of themselves. Such other active ingredients are described below.
[00091] Dosage units can be administered in a single daily dose, or in multiple daily doses.
[00092] The dosage units and systems of the present invention can comprise one or more other active ingredients used to treat and / or prevent respiratory conditions, can be used to treat and / or prevent gastrointestinal conditions, and can be used to treat and / or avoid several other conditions and / or also provide health and well-being benefits as a whole. Health and well-being as a whole encompasses a wide range of benefits and types of benefits desired, including respiratory health, gastrointestinal health, immune system health, muscle and joint health, cardiovascular health, skin health, oral health / dental, hair health, eye health, reproductive health (including menstrual health), upper airway health, and the like.
[00093] Users may desire a variety of benefits, some non-limiting examples of which include reduced incidence and severity of respiratory conditions and symptoms, reduced incidence and severity of gastrointestinal conditions and symptoms, reduced incidence and severity of symptoms menstrual periods, reduced incidence and severity of symptoms of upper airway disorders, reduced incidence and severity of symptoms and effects of: inflammatory disorders, immunodeficiency, cancer (particularly those of the gastrointestinal and immune systems), appendicitis, autoimmune disorders, multiple sclerosis, disease Alzheimer's disease, amyloidosis, rheumatoid arthritis, arthritis, diabetes mellitus, insulin resistance, bacterial infections, viral infections, fungal infections, periodontal disease, urogenital disease, surgery-associated trauma, surgery-induced metastatic disease, sepsis, weight loss, gain weight, accumulation of excessive adipose tissue, anorexia, fever control, cachexia, wound healing, ulcers, intestinal barrier infection, circulatory disorders, coronary heart disease, anemia, blood clotting system disorders, kidney disease, central nervous system disorders, disease liver disease, ischemia, nutritional disorders, osteoporosis, endocrine disorders, and epidermal disorders.
[00094] Some non-limiting examples of health benefits include improving or reducing the effects of aging including attention and levels of mental activity, thereby preventing weight loss during and after an infection, improving glucose control, including improving insulin sensitivity , reducing insulin resistance and attenuating postprandial glucose absorption, good, maintained and / or improved joint and mobility function, decreased cholesterol and decreased blood pressure, improved skin appearance and tone, enhanced hair appearance and texture , and combinations thereof.
[00095] Some non-limiting examples of such other active ingredients used to provide such benefits include vitamins, minerals, elements, plant-derived materials, energetic materials, probiotics, fibers, prebiotics, and combinations thereof.
[00096] Dosage units suitable for use with other active ingredients of the present invention are manufactured in numerous product forms, some non-limiting examples of the most common ones including tablets, pills, capsules, gel capsules, capsules filled with solid material, capsules filled with liquid, enteric coated forms, extended release forms, solid tablets, liquid filled tablets, mouth and throat tablets, chewing gum, confectionery, "gummy candies", effervescent tablets, dry dissolvable powders, dissolvable strips, syrups, elixirs and liquids for ingestion, suppositories, sublingual tablets, oral tablets, plasters for transdermal administration of active ingredients, drinks, and food products including sweets and cookies, as well as topical microbicidal compositions, creams and lotions for topical use that release agents that are absorbed into and through the skin and / or mucous membranes, inhalants, creams and lotions and topical use that release volatile agents that are inhaled through the nose into the respiratory tract.
[00097] The dosage units and systems of the present invention may comprise one or more vitamins, some non-limiting examples of which include pro-vitamins and all forms of vitamins C, D, A, B, E, and combinations thereof .
[00098] When certain vitamins (and also certain minerals, metals, elements and the like) are included as components in the form of capsules, tablets and powders, the actual proportions of these various components, in grams per unit dose, are often extremely small , and make individual components difficult to handle, measure and process. Therefore, such components are commonly prepared or purchased as a premix in a vehicle such as sucrose or lactose. Regarding the percentage, by weight, of a certain vitamin as a percentage of a premix or vitamin carrier mixture, such percentages can vary widely depending on the vitamin and the amount of vitamin desired, as would be understood by one skilled in the art. In general, however, for vitamins in a vehicle, the vitamin may comprise, as a percentage, by weight, of the vitamin in relation to the vehicle, from about 0.0001% to about 50%, alternatively from about 0.001% to about 45%, alternatively from about 0.001% to about 40%, by weight, of the vitamin carrier composition.
[00099] The dosage units and systems of the present invention can comprise vitamin C. It is believed that more than 20% of individuals with colds have suboptimal levels of vitamin C. The preferred form of vitamin C for use in the present invention is as acid ascorbic acid or an equivalent salt of ascorbic acid (i.e., calcium ascorbate) or an equivalent derivative of ascorbic acid. Vitamin C can be either in an immediate release form or in a prolonged release form.
[000100] Vitamin C can be administered in a single daily dose, or in multiple daily doses.
[000101] Dosage units may comprise from about 1 mg to about 5000 mg, alternatively from about 20 mg to about 2000 mg, alternatively from about 60 mg to about 1500 mg, and alternatively from about 100 mg to about 1000 mg of vitamin C, per dosage unit.
[000102] The systems can deliver from about 1 mg to about 5000 mg, alternatively from about 20 mg to about 2000 mg, alternatively from about 60 mg to about 1500 mg, and alternatively from about 100 mg to about 1000 mg of vitamin C per day.
[000103] Dosage units and systems may comprise vitamin D. Non-limiting examples of vitamin D suitable for use in the present invention include vitamin D3 (cholecalciferol), vitamin D2 (ergocalciferol) and combinations thereof. Some additional non-limiting examples include metabolites of vitamin D, including calcidiol, calcitriol, and combinations thereof. Vitamin D can be derived from natural or synthetic sources, including from an extract of Solanum glaucophyllum (malacoxylon), Trisetum flavescens (goldhafer) or Cestrum diurnum. Both vitamin D and / or vitamin D glycosides can be used. Vitamin D can be used to treat and / or prevent a respiratory condition, and / or provide general health and well-being benefits.
[000104] Vitamin D can be administered in a single daily dose, or in multiple daily doses.
[000105] Dosage units can deliver, in a single daily dose or in multiple daily doses, from about 50 IU to about 500,000 IU, alternatively from about 500 IU to about 500,000 IU, alternatively from about 1,000 IU at about 500,000 IU, alternatively from about 2,000 IU to about 100,000 IU, alternatively from about 10,000 IU to about 50,000 IU, and alternatively from about 20,000 IU to about 40,000 IU of cholecalciferol per day.
[000106] To treat symptoms of a respiratory condition that is already underway in a mammal, for example a human, can be administered, in a single daily dose, or multiple daily doses, from about 50 IU to about 500,000 IU , alternatively from about 500 IU to about 500,000 IU, alternatively from about 1000 IU to about 500,000 IU, alternatively from about 5,000 IU to about 500,000 IU, alternatively from about 10,000 IU to about 100,000 IU, and alternatively, from about 20,000 to about 50,000 IU cholecalciferol per day.
[000107] To treat or prevent the symptoms of a respiratory condition in a mammal, a single dose or multiple daily doses, from about 50 IU to about 10,000 IU, alternatively from about 500 IU to about 10,000 IU, alternatively from about 1,000 IU to about 5,000 IU, alternatively from about 2,000 IU to about 5,000 IU, and alternatively from about 2,000 IU to about 4,000 IU of cholecalciferol per day.
[000108] Dosing units and systems can also supply vitamin D2 (ergocalciferol). Dosage units can deliver, in a single daily dose or in multiple daily doses, from about 50 IU to about 500,000 IU, alternatively from about 500 IU to about 500,000 IU, alternatively from about 1,000 IU to about 500,000 IU, and alternatively from about 5,000 IU to about 500,000 IU of vitamin D2 per day.
[000109] Dosage units can comprise from about 1.25 microgram (μg) to about 12.5 mg, alternatively from about 12.5 μg to about 12.5 mg, alternatively from about 25 μg to about 12.5 mg, and alternatively about 125 μg to about 12.5 mg of vitamin D3 and / or D2, per dosage unit.
[000110] The dosage units and systems of the present invention can also comprise vitamin A and / or pro-vitamin forms of vitamin A as carotene (s). Vitamin A and carotene can be obtained from sources or animals or vegetables. The animal form of carotene is divided between retinol and dehydroretinol, while vegetable carotene can be divided into four extremely potent groups - alpha-carotene, beta-carotene, gamma-carotene and crypto-carotene. Vitamin A can provide a variety of health and general wellness benefits.
[000111] Some non-limiting examples of vitamins A useful in the present invention include vitamin A, retinol, retinyl palmitate, retinyl acetate, retinyl propionate, beta-carotene, alpha-carotene, beta-cryptoxanthin, and mixtures thereof.
[000112] Vitamin A can be administered in a single daily dose, or in multiple daily doses.
[000113] Dosing units and systems can deliver, in a single daily dose or in multiple daily doses, from about 100 IU to about 10,000 IU, alternatively from about 300 IU to about 5,000 IU, alternatively from about 400 IU to about 2,000 IU, and alternatively from about 500 IU to about 1,000 IU of vitamin A per day. The number of vitamin A species can be expressed as IU or as EAR (equivalent to retinol activity), which is equal to an equivalent amount of retinol in micrograms. For example, 10,000 IU of vitamin A is equivalent to 3000 EAR or 3000 μg retinol.
[000114] Dosage units can comprise from about 30 μg to about 4545 μg, alternatively from about 90 μg to about 1500 μg, alternatively from about 120 μg to about 600 μg, and alternatively about 150 μg to about 300 μg of vitamin A (as retinol), per dosage unit.
[000115] The dosage units and systems of the present invention can comprise one or more B complex vitamins. Compositions containing eight specific B vitamins are generally referred to as "vitamin B complexes". Individual vitamin B compositions are referred to by the specific name of each vitamin (for example, B1, B2, B3, etc.). B-complex vitamins often work together to deliver numerous health benefits and these include, but are not limited to, maintaining and supporting metabolic rate, maintaining healthy skin and muscle tone, improving nervous and immune system function, promoting cell growth and division and together they can also help fight symptoms of stress, depression, and cardiovascular disease. All B vitamins are water soluble and are dispersed in the body. Most B vitamins need to be replenished daily, as the excess is eliminated in the urine.
[000116] Some non-limiting examples of B vitamins useful in the present invention include vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine) , vitamin B7 (biotin), vitamin B9 (folic acid), vitamin B12 (cyanocobalamin), and combinations thereof.
[000117] The B vitamins described below can be administered in a single daily dose, or in multiple daily doses.
[000118] Dosage units can comprise from about 200 μg to about 50 mg, alternatively from about 400 μg to about 20 mg, and alternatively from about 500 μg to about 10 mg of vitamin B1, per unit dosage. The systems can deliver from about 200 μg to about 50 mg, alternatively from about 400 μg to about 20 mg, and alternatively from about 500 μg to about 10 mg of vitamin B1, per day.
[000119] Dosage units can comprise from about 100 μg to about 200 mg, alternatively from about 200 μg to about 100 mg, and alternatively from about 500 μg to about 50 mg of vitamin B2, per unit dosage. The systems can deliver from about 100 μg to about 200 mg, alternatively from about 200 μg to about 100 mg, and alternatively from about 500 μg to B2 about 50 mg of vitamin, per day.
[000120] Dosage units may comprise from about 1 mg to about 500 mg, alternatively from about 2 mg to about 250 mg, and alternatively from about 5 mg to about 100 mg of vitamin B3, per unit dosage. The systems can deliver from about 1 mg to about 500 mg, alternatively from about 2 mg to about 250 mg, and alternatively from about 5 mg to about 100 mg of vitamin B3, per day.
[000121] Dosage units may comprise from about 500 μg to about 1000 mg, alternatively from about 1000 μg to about 500 mg, and alternatively from about 2000 μg to about 100 mg of vitamin B5, per unit dosage. The systems can deliver from about 500 μg to about 1000 mg, alternatively from about 1000 μg to about 500 mg, and alternatively from about 2000 μg to about 100 mg of vitamin B5, per day.
[000122] Dosage units may comprise from about 200 μg to about 500 mg, alternatively from about 500 μg to about 250 mg, and alternatively from about 1000 μg to about 100 mg of vitamin B6, per unit dosage. The systems can deliver from about 200 μg to about 500 mg, alternatively from about 500 μg to about 250 mg, and alternatively from about 1000 μg to about 100 mg of vitamin B6, per day.
[000123] Dosage units can comprise from about 200 μg to about 500 mg, alternatively from about 500 μg to about 250 mg, and alternatively from about 1000 μg to about 100 mg of vitamin B6, per unit dosage. The systems can deliver from about 200 μg to about 500 mg, alternatively from about 500 μg to about 250 mg, and alternatively from about 1000 μg to about 100 mg of vitamin B6, per day.
[000124] Dosage units can comprise from about 50 μg to about 2000 μg, alternatively from about 100 μg to about 1000 μg, and alternatively from about 200 μg to about 500 μg of vitamin B9, per unit dosage. The systems can deliver from about 50 μg to about 2000 μg, alternatively from about 100 μg to about 1000 μg, and alternatively from about 200 μg to about 500 μg of vitamin B9, per day.
[000125] Dosage units may comprise from about 0.5 μg to about 3000 μg, alternatively from about 1 μg to about 1500 μg, and alternatively from about 2 μg to about 750 μg of vitamin B12, for example dosing unit. The systems can comprise from about 50 μg to about 2000 μg, alternatively from about 100 μg to about 1000 μg, and alternatively from about 200 μg to about 500 μg of vitamin B9, per day.
[000126] Dosage units and systems may comprise vitamin E. Vitamin E is a soluble antioxidant lipid and provides defenses against damage by cellular oxidation. The term "vitamin E" typically includes eight different chemical forms: four tocopherols and four tocotrienools. The most biologically active form of vitamin E is alpha-tocopherol.
[000127] Vitamin E can be administered in a single daily dose, or in multiple daily doses.
[000128] Dosage units may comprise from about 1 mg to about 1000 mg of vitamin E, alternatively from about 1 mg to about 800 mg of vitamin E, and alternatively from about 2 mg to about 200 mg of vitamin E, per dosage unit.
[000129] The systems may comprise from about 1 mg to about 1000 mg of vitamin E, alternatively from about 1 mg to about 800 mg of vitamin E, and, alternatively, from about 2 mg to about 200 mg of vitamin E per day.
[000130] The dosage units and systems of the present invention can comprise minerals, metals and / or elements. Some non-limiting examples of minerals, metals and elements useful in the systems of the present invention include: zinc, iron, calcium, iodine, copper and selenium. Adequate intake of iron, zinc, copper and selenium supports a Th1 cytokine-mediated immune response that helps to circumvent a Th2 anti-inflammatory response and an increased risk of extracellular infections. When present, minerals, metals and / or elements may be in or on a suitable vehicle, and comprise from about 1% to about 50% by weight, and alternatively from about 2% to about 30% by weight of the composition comprising the mineral, metal or element and the vehicle.
[000131] The minerals, metals and elements described here can be administered in a single daily dose or in multiple daily doses.
[000132] The dosage units and systems of the present invention can comprise zinc. Zinc is a trace element in many biochemical and biological routes. Zinc salts are effective against pathogens in direct application, and both zinc gluconate and zinc gluconate glycine have been shown to shorten the duration of symptoms of the common cold.
[000133] Dosage units may comprise zinc in an amount of about 1 mg to about 50 mg, alternatively about 1 mg to about 30 mg, and alternatively about 1 mg to about 25 mg of vitamin , per dosage unit.
[000134] The systems can supply zinc in an amount of about 1 mg to about 50 mg, alternatively from about 1 mg to about 30 mg, and alternatively from about 1 mg to about 25 mg of vitamin, for example day.
[000135] Dosing units and systems can comprise iron. Iron (like Fe2 +, ferrous ion) is a trace element necessary for all living organisms. It is used for the production of hemoglobin that carries oxygen to cells. An insufficient amount of iron causes anemia, which results in fatigue and tiredness and is associated with decreased cellular immunity. However, excess iron can be lethal.
[000136] A non-limiting example of an iron suitable for use in the present invention is the iron bisglycinate salt form, available under the trade name "Ferrochel", from Albion Laboratories Inc., Clearfield, Utah, USA.
[000137] Dosage units may comprise from about 2 mg to about 18 mg, alternatively from about 3 mg to about 15 mg, and alternatively from about 3 mg to about 10 mg of iron, per unit of dosage.
[000138] The systems can deliver from about 2 mg to about 18 mg, alternatively from about 3 mg to about 15 mg, and alternatively from about 3 mg to about 10 mg of iron, per day.
[000139] Dosing units and systems can comprise calcium. Calcium is essential for all living organisms, and is the main material used in the mineralization of bones and carcasses. Calcium is essential for the normal development and maintenance of bones and teeth.
[000140] Dosage units can comprise from about 200 mg to about 1500 mg, alternatively from about 250 mg to about 1200 mg, and alternatively from about 500 mg to about 1000 mg of calcium, per unit of dosage.
[000141] The systems can deliver from about 200 mg to about 1500 mg, alternatively from about 250 mg to about 1200 mg, and alternatively from about 500 mg to about 1000 mg of calcium, per day.
[000142] Dosing units and systems may comprise iodine. Iodine is needed in trace amounts in most living organisms and is commonly used in medicine. Although generally only present and necessary in trace amounts, iodine plays an important role in overall well-being, particularly in children.
[000143] Dosage units may comprise from about 20 μg to about 1 mg of iodine, alternatively from about 30 μg to about 500 μg, and alternatively from about 30 μg to about 100 μg of iodine, for example dosing unit.
[000144] The systems can supply from about 20 μg to about 1 mg of iodine, alternatively from about 30 μg to about 500 μg, and alternatively from about 30 μg to about 100 μg of iodine, per day.
[000145] Dosing units and systems may comprise copper. Copper is a trace element that is used for biological electron transport, wound healing, erythrocyte production, and immune system support and performance. Copper was used as an antimicrobial and anti-arthritic agent.
[000146] Dosage units can comprise from about 200 μg to about 10 mg, alternatively from about 500 μg to about 9 mg, and alternatively from about 1 mg to about 9 mg, per unit dosage.
[000147] The systems can deliver from about 200 μg to about 10 mg, alternatively from about 500 μg to about 9 mg, and alternatively from about 1 mg to about 9 mg of iron, per day.
[000148] Dosing units and systems can comprise iron. Although selenium is toxic in large doses, it is an essential micronutrient for animals. In humans, selenium is a nutrient trace element that works as a cofactor for reducing antioxidant enzymes. Selenium can act as an antioxidant and / or enhance immune activity.
[000149] Dosage units may comprise from about 15 μg to about 400 mg, alternatively from about 20 μg to about 300 mg, and alternatively from about 50 μg to about 200 mg of selenium, per unit of dosage.
[000150] The tapping units can deliver from about 15 μg to about 400 mg, alternatively from about 20 μg to about 300 mg, and alternatively from about 50 μg to about 200 mg of selenium, per day.
[000151] Dosing units and systems may comprise materials derived from plants. For use in the present invention, some non-limiting examples of plant-derived materials include those used in traditional Native American, Chinese, Ayurvedic and Japanese medicine, including flowers, leaves, stems and roots of plants, as well as extracts and components active ingredients isolated from flowers, leaves, stems and roots of plants.
[000152] Some particularly useful plant-derived materials are described below. Particularly useful plant-derived materials are those that have beneficial respiratory, gastrointestinal, general health and energy effects.
[000153] Plant-derived materials can be administered in a single dose or in multiple daily doses.
[000154] The dosage units and systems of the present invention may also comprise materials derived from plants which may be particularly useful in the prevention and / or treatment of respiratory conditions, and / or in the maintenance of respiratory health. Some non-limiting examples of such other plant-derived materials include: Andrografis (Andrographis paniculata), Garlic (Allium sativum L.), Eleutherococcus senticosus (Siberian ginseng), a guaiacol component (cassia oils (Cinnamomum aromaticum), cloves of India (Syzygium aromaticum, Eugenia aromaticum, Eugenia caryophyllata), or cinnamon (Cinnamomum zeylanicum, Cinnamomum verum, Cinnamomum loureiroi, Cinnamomum camphora, Cinnamomum tamala, Cinnamomum burmannii)), borage seed oil (Borago officinalis), sage lavandulaefolia, Salvia lavandulifolia), astragalus (Astragalus membraneceus), eupatorium (Eupatorium perfoliatum), chamomile (Matricaria recutita, Chamaemelum nobile), Cordyceps (Cordyceps sinensis), echinacea (Echinacea angustifolia DC, Echinacea purpurea, Echinacea purida, Echinacea purida, Echinacea purida) L.), Euphorbia, Ginseng (American ginseng, Asian ginseng, Chinese ginseng, Korean red ginseng, Panax ginseng: Panax ssp. including P. ginseng CC Meyer, and P. quinquefolius L.), Golden seal (Hydrastis canadensis L.), greater celandine (Chelidonium majus), horseradish (Armoracia rusticana, Cochlearia armoracia), Kiwi (Actinidia delicious, Actinidia chinensis), Maitake mushrooms (Grifola frondosa) mistletoe (Visvum album L.), geranium (Pelargonium menosides), mint / mint oil (mint x peperita L.), propolis, American elm (Ulmus rubra Muhl, Ulmus fulva Michx), Sorrel (Rumex acetosa L., Rumex acetosella L.), thyme / thymus extract (Thymus vulgaris L.), wild indigo (Baptisia australis), quercetin (a flavanol) and combinations and / or mixtures thereof.
[000155] Some non-limiting examples of plant-derived materials include Andrographis paniculata, Allium sativum, Eleutherococcus senticosus (Siberian ginseng) and a guaiacol component which are described below.
[000156] The dosage units and systems of the present invention may comprise an andrograph extract, an active component thereof, or mixtures thereof. For use in the present invention, andrografis is a plant of the genus Andrographis, which has a limited number of species in that genus widely present in Asia. Only some of the species are medicinal. In one embodiment, the plant belongs to the species Andrographis paniculata, which can be called Kalmegh in Ayurvedic medicine. Andrographis is typically standardized by quantifying the total amount of andrographolides, which often form 5 to 20% of the extract.
[000157] Andrografis has been shown to be effective in the treatment of colds and flu, and can help to reduce, to some extent, the symptoms or duration of colds. Andrographolides are the main components of andrografis.
[000158] Dosage units can comprise Andrographis paniculata and amounts of about 5 mg to about 50 mg, alternatively from about 10 mg to about 40 mg, and alternatively from about 15 mg to about 30 mg of andrographolides , per dosage unit.
[000159] The systems may comprise Andrographis paniculata in amounts of about 5 mg to about 50 mg, alternatively from about 10 mg to about 40 mg, and alternatively from about 15 mg to about 30 mg of andrographolides, for example day.
[000160] Dosing units and systems may comprise Allium sativum (garlic). Allium sativum has been shown to be effective in reducing many of the cytokines and chemokines involved in the immune response to viral infections. A combination of Allium sativum, and / or allicin, a component of Allium sativum, in the compositions of the present invention can provide relief from cold and flu symptoms.
[000161] Dosage units can comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and, alternatively, about 3% to about 10% of Allium sativum, by weight, of the composition per dosage unit.
[000162] Dosage units can comprise from about 100 mg to about 10,000 mg, alternatively from about 200 mg to about 5000 mg, and alternatively from about 500 mg to about 2000 mg of Allium sativum, per unit dosage.
[000163] The systems can deliver from about 100 mg to about 10,000 mg, alternatively from about 200 mg to about 5000 mg, and alternatively from about 500 mg to about 2000 mg of Allium sativum, per day.
[000164] Dosing units may comprise from about 1000 μg to about 100,000 μg, alternatively from about 2000 μg to about 50,000 μg, and alternatively, from about 5000 μg to about 20,000 μg of allicin, per unit of dosage.
[000165] The systems can deliver from about 1000 μg to about 100,000 μg, alternatively from about 2000 μg to about 50,000 μg, and alternatively from about 5000 μg to about 20,000 μg of allicin per day.
[000166] The dosage units and systems of the present invention can comprise Eleutherococcus senticosus extract. Eleutherococcus is an adaptogen, anti-cholesteremic, moderate anti-inflammatory, antioxidant, which can enhance immune function, and is a relaxing and immune tonic.
[000167] Dosage units may comprise from about 0.001 mg to about 1500 mg, alternatively from 0.01 mg to about 1000 mg, alternatively from 0.1 mg to about 500 mg, alternatively from about 1 mg to about 250 mg, and alternatively, from about 1 mg to about 100 mg of Eleutherococcus senticosus extract, per dosage unit.
[000168] The systems can comprise from about 0.001 mg to about 1500 mg, alternatively from 0.01 mg to about 1000 mg, alternatively from 0.1 mg to about 500 mg, alternatively from about 1 mg to about 250 mg, and alternatively, from about 1 mg to about 100 mg of Eleutherococcus senticosus extract, per day.
[000169] The dosage units and systems may comprise a guaiacol component. The guaiacol component can be a composite mixture containing guaiacol or a 4-substituted derivative thereof. Some non-limiting examples of such 4-substituted guaiacol derivatives include eugenol, isoeugenol, dihydroeugenol, vanylyl butyl ether, vanillin (4-formyl-guaiacol), 5-propenylguaetol, 4-ethyl-2-methoxyphenol, acetate 4 -allyl-2-methoxyphenol, and 4-methyl guaiacol. In one embodiment, the 4-substituted guaiacol derivative is eugenol.
[000170] Cassia, cloves and cinnamon each contain guaiacol or 4-substituted derivatives of these substances, or mixtures thereof. Consequently, essential oils, extracts and any product derived from cassia, cloves, cinnamon, or any mixture thereof can be used as a source of the guaiacol component of the present invention. Essential oils of cassia, cloves, or cinnamon can be particularly useful. Clove oil can be particularly useful. Products derived from cassia, cloves or cinnamon may contain eugenol in useful levels.
[000171] The guaiacol component can comprise from about 0.0001% to about 1%, alternatively from about 0.001% to about 0.5%, alternatively from about 0.001% to about 0.07%, and alternatively, from about 0.001% to about 0.02%, by weight, of the composition of a dosage unit.
[000172] Other plant-derived materials useful in the systems of the present invention may have beneficial effects on the gastrointestinal tract, some non-limiting examples of which include calming or demulcent effects, gas-reducing or carminative effects, antidiarrheal or astringent effects, laxative effects , purgatives, cathartics, purgatives or laxatives, analgesic effects, antispasmodic or relaxation effects, stimulating or exciting effects, or digestive aid effects.
[000173] Some non-limiting examples of such other plant-derived materials useful in the methods and systems of the present invention include the ginger family (Zigiberaceae), licorice root (Glycyrrhizin glabra), marshmallow root (Althea officinalis, Althea radix), chamomile (Matricariae flos, Chamaemelum nobile), fennel oil, fennel seed (Foeniculum vulgare), caraway oil, caraway seed (Carum carvi, Carvi fructus, Carvi aetheroleum), melissa (Melissae folium, Melissa), herb heather (Murrubii herba), linseed, linseed alpha-linoleic acid (Lini semen), and combinations thereof.
[000174] Materials from the ginger family (Zigiberaceae), such as the non-limiting example Zingiber officinale, are particularly useful.
[000175] Ginger can be used in a form selected from the group consisting of rhizome (root), equivalent extract, tincture, oil, infusion, decoction, crystals, powder, and combinations thereof.
[000176] Dosage units may comprise from about 50 mg to about 10 grams (g), alternatively from about 50 mg to about 5 g, and alternatively from about 100 mg to about 5 g of ginger ( Zingiber officinale), per dosage unit.
[000177] The systems can comprise from about 50 mg to about 10 g, alternatively from about 50 mg to about 5 g, and alternatively from about 100 mg to about 5 g of ginger (Zingiber officinale), for example dosing unit.
[000178] The dosage units and systems of the present invention can comprise materials that have energy boosting / boosting benefits. Such energy benefits are useful for health and well-being as a whole, as well as for treating conditions such as respiratory and gastrointestinal conditions, to provide individuals afflicted by such conditions with more energy or a perception of more energy, to allow such individuals maintain their daily routines while treating a condition such as a respiratory or gastrointestinal condition.
[000179] Some non-limiting examples of these materials include the following, many of which provide multiple benefits including benefits for respiratory and gastrointestinal conditions: caffeine (a stimulant and diuretic), vitamin B complex, green tea and black tea (which can be used for the stimulating and diuretic properties of the caffeine contained therein), taurine, rhodiola rosea, Siberian ginseng (Eleutherococcus senticosus), vitamin C, iron, CoQ10, L-carnitine, L-theanine, vitamin D, guarana (Paullinia cupana), magnesium, Schizandra chinensis, yerba mate (Ilex paraguariensis), goji (Wolfberry), quercetin (a flavanol), sarandi (gooseberry from India), açaí (of the genus Euterpe), maca (Lepidium meyenii), ginkgo biloba, glucuronolactone, ginseng panax ( of a species within Panax, a genus of 11 species of slow-growing perennial plants with succulent roots, in the Araliaceae family), Equinacea (genus of nine species of herbaceous plants in the Asterac family eae), red shrub (Aspalathus linearis), DHEA, aromas and aromatherapy, noni (Morinda citrifolia), mangostin (Garcinia mangostana), and selenium.
[000180] The energy reinforcing material can be administered is a single daily dose or in multiple daily doses.
[000181] The dosage units may comprise from 1 μg to about 10 g, alternatively from about 1 mg to about 5 g, and alternatively, from about 100 mg to about 5 mg of energizing / boosting material, per dosage unit.
[000182] The systems can deliver from about 1 μg to about 10 g, alternatively from about 1 mg to about 5 g, and alternatively from about 100 mg to about 5 g of energy boosting / enhancing material, per day.
[000183] The dosage units and systems can comprise a probiotic. Probiotics can be useful in the treatment and / or prevention of respiratory conditions, treatment and / or prevention of gastrointestinal conditions, as well as in providing general health benefits. For use in the present invention, the "probiotic" includes natural and / or genetically modified, viable or dead microorganisms, processed compositions of microorganisms, their constituents and components such as proteins and carbohydrates, or purified fractions of bacterial yeasts, which affect beneficially a host. The general use of probiotics in the present invention is in the form of viable cells. However, the use can be extended to non-viable cells such as dead cultures or compositions containing beneficial factors expressed by the probiotic. Exterminated cultures can include thermally exterminated microorganisms, or microorganisms exterminated by exposure to altered pH or subjected to pressure. For the purpose of the present invention, the "probiotic" is additionally designed to include metabolites generated by microorganisms during fermentation, if they are not indicated separately. These metabolites can be released in the fermentation medium, or they can be stored inside the microorganism. For use in the present invention, the "probiotic" also includes bacteria, bacterial homogenates, bacterial proteins, bacterial extracts, bacterial yeast supernatants, and mixtures thereof, which perform beneficial functions to a host animal when supplied in a therapeutically effective amount.
[000184] For use in the present invention, the term "therapeutically effective amount" with reference to the probiotic described herein, means that the amount of probiotic is sufficient to provide the desired effect or benefit to a host animal that needs treatment, but lowers the sufficient to avoid adverse effects such as toxicity, irritation, or an allergic response, in proportion to a reasonable risk / benefit ratio when used in the manner indicated in the present invention. The specific "therapeutically effective amount" will vary with such factors as the particular health problem being treated, the physical condition of the host animal, the duration of treatment, the nature of the concomitant therapy (if any), the specific dosage form a be used, the vehicle employed, the solubility of the dosage form, and the specific dosage regimen.
[000185] The abbreviation "UFC" refers to "colony-forming units" and, for use in the present invention, designates the number of probiotic cells revealed by microbiological counts on agar plates, as is commonly understood in the art.
[000186] Some non-limiting examples of probiotic bacteria suitable for use in the present invention include strains of Streptococcus lactis, Streptococcus cremoris, Streptococcus diacetylactis, Streptococcus thermophilus, Lactobacillus bulgaricus, Lactobacillus acidophilus, lactobacillus, lactobacillacillus plantarum, Lactobacillus rhamnosus, Lactobacillus delbruekii, thermophilus Lactobacillus, Lactobacillus fermentii, salivarius Lactobacillus, Lactobacillus reuteri, Lactobacillus brevis, Lactobacillus paracasei, Lactobacillus gasseri, Pediococcus cerevisiae, Bifidobacterium longum, Bifidobacterium infantis, adolescentis Bifidobacterium bifidum Bifidobacterium, Bifidobacterium animalis, Bifidobacterium pseudolongum, Bifidobacterium thermophilum, Bifidobacterium lactis, Bifidobacterium bulgaricus, Bifidobacterium breve, Bifidobacterium subtilis, Escherichia coli and strains of the genera that include Bacillus, Bacteroi des, Enterococcus (for example, Enterococcus faecium) and Leuconostoc, and mixtures and / or combinations thereof.
[000187] Modalities of the dosage units of the present invention comprise strains of lactic acid-forming bacteria selected from the genus Lactobacillus and Bifidobacterium, such as Lactobacilius acidophilus, and Bifidobacterium lactis, and combinations and / or mixtures thereof.
[000188] In one embodiment, the dosage unit comprises a composition comprising a therapeutically effective amount of Lactobacillus.
[000189] Non-limiting examples of Lactobacillus suitable for use in the present invention include strains of Lactobacillus bulgaricus, Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bifidus, Lactobacillus casei, Lactobacillus lactis, Lactobacillusillacillusillus, lactobacillusillus Lactobacillus salivarius, Lactobacillus reuteri, Lactobacillus brevis, Lactobacillus paracasei, Lactobacillus gasseri and combinations thereof.
[000190] The probiotic can be administered in a single daily dose or in multiple daily doses.
[000191] Dosage units may comprise at least about 103 CFU, alternatively from about 103 to about 1014 CFU, alternatively from about 106 to about 1012 CFU, and, alternatively, from about 108 to about 1011 CFU UFC of Lactobacillus, per dosage unit. Lactobacillus can be administered either in viable form, or as dead cells, or distillates, isolates or other fractions of the Lactobacillus fermentation products used here, or any mixture or combination thereof.
[000192] The systems can deliver at least about 103 CFU, alternatively from about 103 to about 1014 CFU, alternatively from about 106 to about 1012 CFU, and alternatively from about 108 to about 1011 CFU of Lactobacillus, per day.
[000193] In one embodiment, the dosage units comprise a composition comprising a therapeutically effective amount of a Bifidobacterium strain, which may be mammalian. The treated mammal and a mammalian source of Bifidobacterium isolation can be, but need not be, independent.
[000194] Non-limiting examples of Bifidobacterium suitable for use in the present invention include strains of Bifidobacterium longum, Bifidobacterium infantil, Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium animalis, Bifidobacterium pseudolongum, Bifidobacterium bifidifacterium, Bifidobacterium bacterium, thermophilic and mixtures and / or combinations thereof.
[000195] In one embodiment of the present invention, the dosage units may comprise at least about 103 CFU, alternatively from about 103 to about 1014 CFU, alternatively from about 106 to about 1012 CFU, and, alternatively, from about 108 to about 1011 CFU of Bifidobacterium, per dosage unit. Bifidobacterium can be administered or in viable form, or as dead cells, or distillates, isolates or other fractions of the fermentation products of the Bifidobacterium used herein, or any mixture or combination thereof.
[000196] The systems can supply at least about 103 UFC, alternatively from about 103 to about 1014 UFC, alternatively from about 106 to about 1012 UFC, and, alternatively, from about 108 to about 1011 UFC in Bifidobacterium, per day.
[000197] As a portion of the dosage unit compositions, the probiotic, as a freeze-dried powder (as would be understood by one skilled in the art) can comprise from about 1% to about 50%, alternatively from about 1 % to about 40%, alternatively from about 1% to about 30%, and, alternatively, from about 2% to about 20%, by weight, of the composition of the dosage unit.
[000198] Dosing units and systems may also comprise fibers. A fiber can be useful in the treatment and / or prevention of gastrointestinal conditions, as well as in providing general gastrointestinal health benefits. For use in the present invention, the term "fiber" means carbohydrate polymers, including those naturally occurring in ready-to-eat foods, those having been obtained from food raw materials through physical, enzymatic or chemical means, and carbohydrate polymers synthetics, which are resistant to digestion and absorption in the small intestine and have partial fermentation in the large intestine.
[000199] Some non-limiting examples of suitable fiber and analogous carbohydrate polymers include pectins, plantago, guar gum, xanthan gum, algins, arabic gum, fructo-oligosaccharides, inulin, agar, beta-glucans, chitins, dextrins, lignin, celluloses non-starch polysaccharides, carrageenan, reduced starch, and mixtures and / or combinations thereof.
[000200] In one embodiment, the fiber is a glucose polymer, preferably one that has branched chains. Among such suitable fibers, one is available under the trade name "Fibersol2", available commercially from Matsutani Chemical Industry Co., Itami City, Hyogo, Japan.
[000201] Other non-limiting examples of suitable fibers include oligosaccharides, such as inulin and their hydrolysis products commonly known as fructo-oligosaccharides, galactooligosaccharides, xylooligosaccharides and starch oligoderivatives.
[000202] The fiber can be supplied in any suitable form. A non-limiting example is in the form of a plant material containing the fiber. Non-limiting examples of suitable plant materials include asparagus, artichoke, onion, wheat, chicory, beet pulp, residues of these source materials and mixtures and / or combinations thereof.
[000203] A non-limiting example of a fiber of this material of plant origin is the inulin extract obtained from the chicory extract. Suitable inulin extracts can be obtained from Orafti SA of Belgium under the registered trademark Raftiline®. Alternatively, the fiber may be in the form of a fructo-oligosaccharide that can be obtained from Orafti SA of Belgium under the registered trademark Raftilose®. Alternatively, an oligosaccharide can be obtained by hydrolyzing inulin, using enzymatic methods, or by using microorganisms, as will be understood by those skilled in the art. Alternatively, the fiber can be inulin and / or inulin with removed sugar available from Cargill Health & Food Technologies, Wayzata, MN, USA, or from Cosucra SA, Warcoing, Belgium.
[000204] In another modality, the fiber can be plantago, which can be obtained from The Procter & Gamble Company, Cincinnati, OH, under the trademark Metamucil®.
[000205] Fiber can be administered in a single daily dose, or in multiple daily doses.
[000206] Dosage units may comprise from about 10 mg to about 100 g, alternatively from about 50 mg to about 50 g, alternatively from about 100 mg to about 50 g, alternatively from about 500 mg at about 50 g, and alternatively from about 1 g to about 40 g of fiber, per dosage unit.
[000207] Dosage units can deliver from about 10 mg to about 100 g, alternatively from about 50 mg to about 50 g, alternatively from about 100 mg to about 50 g, alternatively from about 500 mg at about 50 g, and alternatively from about 1 g to about 40 g of fiber per day.
[000208] Dosing units and systems may comprise a prebiotic. Prebiotics can be useful in the treatment and / or prevention of gastrointestinal conditions, as well as in providing general gastrointestinal health benefits.
[000209] For use in the present invention, the term "prebiotic" includes substances or compounds that beneficially affect the host mammal, selectively promoting the growth and / or activity of one or more probiotic bacteria in the gastrointestinal tract of the host animal, forms the normal health of or improving the health of the host. Typically, prebiotics are carbohydrates, (like oligosaccharides), but the term "prebiotic" for use in the present invention does not exclude non-carbohydrates. Several forms of "fiber" have some level of prebiotic effect. Thus, there is a considerable overlap between substances that can be classified as "prebiotics" and those that can be classified as "fibers".
[000210] Some non-limiting examples of prebiotics suitable for use in compositions and methods include plantago, fructo-oligosaccharides, inulin, oligofructose, galacto-oligosaccharides, isomalto-oligosaccharides, xylo-oligosaccharides, soy-oligosaccharides, gluco-oligosaccharides, mangoes , arabinogalactan, arabinoxylan, lactosucrose, glucomannan, lactulose, polydextrose, oligodextran, genci-oligosaccharide, pectic oligosaccharide, xanthan gum, arabic gum, hemicellulose, resistant starch and its derivatives, reduced starch, and mixtures and / or combinations thereof.
[000211] The prebiotic can be administered in a single daily dose, or in multiple daily doses.
[000212] Dosage units can comprise from 100 mg to about 100 g, alternatively from about 500 mg to about 50 g, and alternatively, from about 1 g to about 40 g of prebiotic, per dosage unit.
[000213] The systems can comprise from about 100 mg to about 100 g, alternatively from about 500 mg to about 50 g, and alternatively from about 1 g to about 40 g of prebiotic, per day.
[000214] Dosing units and systems can comprise at least one polyphenol. Polyphenols are known to have antioxidant activity and anti-inflammatory effects, and thus can be useful in the treatment and / or prevention of respiratory and gastrointestinal conditions, as well as in providing general health benefits. Some non-limiting examples of polyphenol sources useful in the present invention include tea extract, rosemary extract, rosmarinic acid, coffee extract, caffeic acid, tourmic extract, blueberry extract, grape extract, grape seed extract, soy, and mixtures and combinations thereof.
[000215] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and, alternatively, about 3% to about 10% polyphenol, by weight, of the composition of the dosage unit.
[000216] Non-limiting sources of tea extract for use in the present invention include black tea, white tea, oolong tea, and / or green tea.
[000217] When tea extract is present, the dosage units can comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and, alternatively, from about 3% to about 10% of tea extract, by weight, of the composition of the dosage unit.
[000218] When the tea extract is green tea, the dosage units can comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1 % to about 15%, alternatively from about 1% to about 10%, and, alternatively, from about 3% to about 10% of tea extract, by weight, of the composition of the dosage unit.
[000219] Constituents of rosemary or rosemary extract are caffeic acid and its derivatives, such as rosmarinic acid. These compounds have antioxidant activity and anti-inflammatory effects. Non-limiting sources of rosemary extract suitable for use in the present invention include rosemary.
[000220] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and alternatively about 3% to about 10% rosemary extract, by weight, of the composition of the dosage unit.
[000221] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and, alternatively, about 3% to about 10% rosmarinic acid, by weight, of the composition of the dosage unit.
[000222] The main constituent of the coffee extract is caffeic acid and, without sticking to the theory, it appears to have an antioxidant activity.
[000223] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and alternatively about 3% to about 10% coffee extract extract, by weight, of the composition of the dosage unit.
[000224] When coffee extract is present, non-limiting sources of coffee extract include coffee bean, coffee, coffee seed, coffee fruit. When caffeic acid is present, non-limiting sources of caffeic acid suitable for use in the present invention include tea, berries, coffee bean, coffee, coffee seeds, coffee fruits, rosemary extract, and / or grape seed extract.
[000225] Dosage units can comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and, alternatively, about 3% to about 10% caffeic acid, by weight, of the composition of the dosage unit.
[000226] Turmeric is a spice that comprises a main active compound which is curcumin. Curcumin is a bioactive polyphenol vegetable pigment. Without sticking to the theory, curcumin is believed to have antioxidant activity. A non-limiting source of turmeric extract for use in the present invention is tumeral (turmeric)
[000227] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and, alternatively, from about 3% to about 10% of turmeric extract, by weight, of the composition of the dosage unit.
[000228] Dosing units and systems may comprise blueberry extracts. Blueberry extract is rich in anthocyanins that have antioxidant activity. A non-limiting source of blueberry extract is blueberry.
[000229] The dosage unit may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and, alternatively, about 3% to about 10% blueberry extract, by weight, of the composition of the dosage unit.
[000230] Dosing units and systems may comprise grape seed extract. Grape seed extract is rich in procyanidins that have antioxidant activity. The grape seed extract comprises about 38.5% procyanidin. A non-limiting source of grape seed extract is grape seed.
[000231] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10% and, alternatively, from about 3% to about 10% of grape extract, by weight, of the composition of the dosage unit.
[000232] Dosing units and systems may comprise grape extracts. Grape extract is rich in resveratrol, which has antioxidant activity. A non-limiting source of grape extract consists of whole grapes.
[000233] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and alternatively about 3% to about 10% grape extract, by weight, of the composition of the dosage unit.
[000234] Dosage units and systems may comprise soy extract. Soy extract is rich in isoflavonoids, such as genistein and diadzein, which have diverse properties beneficial to health. A non-limiting source of soy extract is soy.
[000235] Dosage units may comprise from about 0.01% to about 90%, alternatively from about 0.1% to about 35%, alternatively from about 1% to about 15%, alternatively from about 1% to about 10%, and alternatively about 3% to about 10% soy extract, by weight, of the composition of the dosage unit.
[000236] Dosing units and systems may also comprise active ingredients particularly useful for animals, some non-limiting examples of which include dogs, cats, cows, rabbits and horses. Such active ingredients can treat and / or prevent respiratory and / or gastrointestinal conditions, as well as maintain and optimize the health of the animal as a whole. While the types of active ingredients described above can be used by both humans and other mammals, such as pets, the units and dosage systems of the present invention can also include active ingredients particularly useful for non-human animals. In addition, although the active ingredients described in this section are particularly useful for non-human animals, several of the active ingredients described in this section are also suitable for use in humans.
[000237] Some non-limiting examples of such active ingredients include polyphosphates such as sodium hexametapostate (SHMP), sodium pyrophosphate, sodium tripolyphosphate, zinc chloride, copper gluconate, stannous chloride, stannous fluoride, sodium fluoride, trichosan, hydrochloride glucosamine, chondroitin sulfate, green shell mussels, blue shell mussels, methyl sulfonyl methane (MSM), boron, boric acid, phytoestrogens, phytoandrogens, genistein, diadzein, L-carnitine, chromium picolinate, chromium tripicolinate chromium, anti-glucose metabolites including 2-deoxy-D-glucose, 5-thio-D-glucose, 3-O-methyl glucose, anhydrous sugars including 1,5-anhydrous-D-glycitol, 2,5-anhydrous -D-glycitol, and 2,5-anhydrous-D-mannitol, manoeptulose, avocado extract comprising manoeptulose, fiber; prebiotics including, in particular, fructo-oligosaccharides, acid / base modifiers, potassium citrate, potassium chloride, calcium carbonate, calcium chloride, sodium bisulfate, eucalyptus, lavender, peppermint, and combinations thereof.
[000238] The active ingredient can be administered in a single daily dose, or in multiple daily doses. The active ingredient can be incorporated into several types of dosage units, as described above. Some non-limiting examples of dosage units that are particularly useful for animals are snacks and biscuits.
[000239] Dosage units, that is, each snack or biscuit, can comprise from about 0.0001 mg to about 10 g, alternatively from about 0.001 mg to about 10 g, alternatively from about 0.01 mg to about 10 mg, alternatively from about 1 mg to about 10 g, alternatively from about 10 mg to about 5 g, alternatively from about 30 mg to about 5 g, alternatively from about 30 mg to about of 3 g, alternatively from about 300 mg to about 3 g, alternatively from about 300 mg to about 1.5 g of active ingredient, alternatively from about 30 mg to about 600 mg, alternatively from about 30 mg to about 300 mg of active ingredient, per dosage unit.
[000240] The systems can deliver from about 0.0001 mg to about 10 g, alternatively from about 0.001 mg to about 10 g, alternatively from about 0.01 mg to about 10 mg, alternatively from about 1 mg to about 10 g, alternatively from about 10 mg to about 5 g, alternatively from about 30 mg to about 5 g, alternatively from about 30 mg to about 3 g, alternatively from about 300 mg to about 3 g, alternatively from about 300 mg to about 1.5 g of active ingredient, alternatively from about 30 mg to about 600 mg, and alternatively from about 30 mg to about 300 mg of active ingredient per day.
[000241] The units and dosage systems of the present invention may also comprise optional materials, some non-limiting examples of which include amino acids, fatty acids, carotenoids, antioxidants, and combinations thereof. Optional materials can be administered in a single daily dose or in multiple daily doses.
[000242] When protein is degraded by digestion, the result is 22 known amino acids. Eight are essential (they cannot be produced by the body), the others are non-essential (that is, they can be produced by the body with proper nutrition).
[000243] When an amino acid is present, it is selected from the group consisting of l-tryptophan, taurine, histidine, carnosine, alanine, cysteine, and mixtures and / or combinations thereof.
[000244] Dosage units may comprise at least about 0.05%, alternatively from about 0.05% to about 10%, and, alternatively, from about 0.2% to about 5% of a amino acid, by weight, of the composition of the dosage unit.
[000245] Dosage units may comprise from about 250 mg to about 2500 mg, alternatively from about 300 mg to about 2000 mg, and alternatively from about 400 mg to about 1000 mg of amino acid, per unit of dosage.
[000246] The systems can deliver from about 250 mg to about 2500 mg, alternatively from about 300 mg to about 2000 mg, and alternatively from about 400 mg to about 1000 mg of amino acid, per day.
[000247] A "carotenoid" is a class of pigments that exists in the tissues of aquatic plants, algae, bacteria and fungi. When a carotenoid is present, the carotenoid is selected from the group consisting of lutein, astaxanthin, zeaxanthin, bixin, lycopene, beta-carotene and mixtures and / or combinations thereof.
[000248] Dosage units may comprise at least about 0.01%, alternatively from about 0.01% to about 20%, and, alternatively, from about 0.05% to about 10% carotenoid by weight of the composition of the dosage unit.
[000249] Dosage units and systems may comprise an antioxidant in addition to the vitamins, plant-derived materials, elements, and carotenoids described above that have antioxidant properties. As used here, an antioxidant is an enzyme or other organic molecule that can neutralize the effects of oxygen on tissues.
[000250] When an antioxidant is present, some non-limiting examples of such antioxidants include tocopherols (vitamin E, described above), vitamin C (described above), vitamin A (described above), plant-derived materials (described above), carotenoids (described above), selenium (described above), CoQ10, and mixtures and / or combinations thereof.
[000251] The dosage units and systems of the present invention can comprise coenzyme Q10 (CoQ10). The dosage units comprise at least about 0.01%, alternatively from about 0.01% to about 10%, and, alternatively, from about 0.2% to about 5% of coenzyme Q10, by weight , of the composition of the dosage unit.
[000252] Dosage units may comprise from about 1 mg to about 400 mg, alternatively from about 2 mg to about 400 mg, and alternatively from about 3 mg to about 300 mg of Coenzyme Q10, per unit dosage.
[000253] The systems can deliver from about 1 mg to about 400 mg, alternatively from about 2 mg to about 400 mg, and alternatively from about 3 mg to about 300 mg of Coenzyme Q10, per day.
[000254] The dosage units and systems may comprise a fatty acid. Long-chain fatty acids play an important role in arachidonic acid metabolism that could be useful in modulating pain and inflammation. Currently, long-chain fatty acids, like omega-6 fatty acids, are used for their immunological and antioxidant health benefits.
[000255] Some non-limiting examples of suitable long-chain fatty acids include alpha-linoleic acid, gamma-linolenic acid, linoleic acid, eicosapentanoic acid and docosahexanoic acid. Fish oils are an adequate source of eicosapentanoic acids (EPA) and docosahexanoic acid (DHA).
[000256] Dosage units comprise at least about 0.05%, alternatively at least about 0.1%, and, alternatively, at least about 0.15% DHA, by weight, of the composition of the unit. dosage.
[000257] The dosage units comprise at least about 0.05%, alternatively at least about 0.1%, and, alternatively, at least about 0.15% EPA, by weight, of the composition of the unit. dosage.
[000258] The dosage units of the present invention can also comprise an excipient, as would be understood by those skilled in the art with regard to the production of various types of dosage units. Some non-limiting examples of excipients include microcrystalline cellulose, dicalcium phosphate, stearic acid, magnesium stearate, corn starch, lactose, sodium croscarmellose, sodium starch glycolate, polyvinylpyrrolidone, gelatin, and combinations thereof.
[000259] Dosage units may comprise from about 1% to about 99%, alternatively from about 2% to about 70%, alternatively from about 3% to about 50%, alternatively from about 5% about 30%, and, alternatively, about 6% to about 25%, excipient, by weight, of the composition of the dosage unit.
[000260] The dosage units of the present invention can also comprise one or more of a wide range of optional ingredients and process aids, as would be understood by those skilled in the art with regard to the production of various dosage forms. Some non-limiting examples of optional ingredients include plasticizers, dyes, flavors, sweeteners, buffering agents, slip aids, vehicles, pH adjusting agents, natural ingredients, stabilizers, biological additives such as enzymes (including proteases and lipases), chemical additives, refrigerants, chelating agents, denaturants, medicinal astringents, emulsifiers, external analgesics, fragrance compounds, humectants, opacifying agents (such as zinc oxide and titanium dioxide), antifoaming agents (such as silicone), preservatives (such as butylated toluene hydroxy (BHT) and butylated anisol hydroxy (BHA), propyl gallate, benzalkonium chloride, EDTA, benzyl alcohol, potassium sorbate, parabens and mixtures thereof), reducing agents, solvents, hydrotropes, solubilizing agents, suspending agents (non-surfactants), solvents, viscosity-increasing agents (aqueous and non-aqueous), scavengers, keratolytics, and the like air, and mixtures and / or combinations thereof.
[000261] In general, unless otherwise specified, dosage units may comprise from about 0.001% to about 99%, alternatively from about 0.01% to about 80%, alternatively from about 0.01% to about 50%, and, alternatively, from about 0.01% to about 10%, of optional ingredient (s), by weight, of the composition of the dosage unit.
[000262] The blister cards and systems described above provide intuitive dosing instructions that assist users in administering numerous dosing units during different time periods, such as daily. Blister cards can be sized to be easily accommodated in a pocket or handbag. If all dosing units are not consumed, the information provided by the blister cards can provide an indication to the user when the forgotten dosage units should be consumed.
[000263] It should be noted that terms such as "preferably", "generally," "commonly", and "typically" are not used in the present invention to limit the scope of the modalities claimed or even imply that certain resources are critical, essential , or even important for structures or functions. Instead, these terms are intended merely to highlight alternative or additional features that may or may not be used in a given modality.
[000264] For the purpose of describing and defining the various modalities, it should also be noted that the term "substantially" is used in the present invention to represent the inherent degree of uncertainty that can be attributed to any quantitative comparison, value, measurement , or other representation. The term "substantially" is also used in the present invention to represent the degree to which a quantitative representation can vary from a stated reference without resulting in a change in the basic function of the subject in question.
[000265] The dimensions and values presented in the present invention should not be understood as being strictly limited to the exact numerical values mentioned. Instead, unless otherwise specified, each of these dimensions is intended to mean both the mentioned value and a range of functionally equivalent values around that value. For example, a dimension displayed as "40 mm" is intended to mean "about 40 mm".
[000266] Each of the documents cited in the present invention, including any cross-reference, related patent or patent application, is hereby incorporated in its entirety, by way of reference, unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art in relation to any invention presented or claimed in this document, or that it, alone or in any combination with any other reference or references, teaches, suggest or present any invention like that. In addition, if there is a conflict between any meaning or definition of a term mentioned in this document and any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document will take precedence.
[000267] Although particular embodiments of the present invention have been illustrated and described, it should be apparent to those skilled in the art that various other changes and modifications can be made without departing from the character and scope of the invention. Therefore, it is intended to cover in the appended claims all such changes and modifications that fall within the scope of the present invention.

权利要求:
Claims (6)
[0001]
1. Daily blister card comprising: a back side (18); a front side (16) opposite the rear side, the front side comprising: a face (20) having an outer periphery (22) and a total flat area bounded by the outer periphery; one or more blisters (34, 36, 38) extending outwardly on the face containing at least three unit doses (13, 13, 15), each of the one or more blisters includes a shoulder (83) which contacts the cavity support surface (306) and a projected cavity area (85) delimited by the shoulder that is projected onto the shoulder delimited cavity area that is projected onto the cavity support surface, the at least three unit doses being visible from outside the one or more blisters; and dosing instructions; characterized by the fact that the unit doses are adapted to be consumed within 12 hours to 24 hours and at least one unit dose is a daytime unit dose comprising phenylephrine or pseudophedrine and at least one unit dose is a night unit dose comprising succinate doxylamine.
[0002]
2. Daily blister card, according to claim 1, characterized by the fact that said daytime unit dose is non-sedative and said nighttime unit dose comprises a sedative.
[0003]
3. Daily blister card, according to claim 1 or 2, characterized by the fact that the total projected cavity area (85) of the one or more blisters is not greater than 45 percent of the total flat area bounded by the outer periphery ( 22).
[0004]
4. Daily blister card according to any one of claims 1 to 3, characterized by the fact that the outer periphery (22) is circular in shape and the total projected cavity area (85) of the one or more blisters is not greater than 40 percent of the total flat area bounded by the outer periphery (22).
[0005]
5. Daily blister card according to any one of claims 1 to 4, characterized by the fact that the outer periphery (22) is rectangular in shape and the total projected cavity area (85) of the one or more blisters is not greater than 25 percent of the total flat area bounded by the outer periphery (22).
[0006]
6. Daily blister card according to any one of claims 1 to 5, characterized by the fact that the total flat area bounded by the outer periphery is not greater than 125 cm2.

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引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

---

US2578444A|1943-10-12|1951-12-11|Nicolle Charles|Multicapsule sheet|

---

US3003273A|1958-11-06|1961-10-10|Tapper Samuel|Prescription label panels|

---

US3503493A|1968-01-08|1970-03-31|Hoffmann La Roche|Medicament packaging device|

---

GB1601885A|1978-05-30|1981-11-04|Sterwin Ag|Packaging|

---

IL58649A|1978-11-10|1982-04-30|Beecham Group Ltd|Pharmaceutical dispensing container|

---

US4669613A|1983-12-07|1987-06-02|Richard Collens|Medical reminder device|

---

US4553670A|1981-10-30|1985-11-19|Richard Collens|Medical reminder device|

---

US4473156A|1982-11-05|1984-09-25|St. Paul-Ramsey Hospital Medical|Method and apparatus for accurately selecting storing and dispensing pills|

---

US4958736A|1986-03-18|1990-09-25|Gynex, Inc.|Package for oral contraceptive tablet|

---

SE465317B|1986-09-25|1991-08-26|Astra Laekemedel Ab|MEDICINAL PACKAGING AND COMBINATION PACKAGING FOR MEDICINAL PRODUCTS AND APPLICATION OF MEDICINAL PACKAGING FOR PREPARING A COMBINATION PACKAGING|

---

ES2107499T3|1991-04-29|1997-12-01|Berlex Lab|DEVICE FOR CONTAINING TABLETS IN BLISTER CONTAINERS.|

---

US5265728A|1991-04-29|1993-11-30|Berlex Laboratories, Inc.|Arrangement for retaining blister pack tablets|

---

USD370625S|1994-01-21|1996-06-11|John Wyeth & Brother Limited|Pharmaceutical package|

---

US5785180A|1995-06-22|1998-07-28|G. D. Searle & Co.|Child-resistant package|

---

SE515129C2|1996-07-01|2001-06-11|Astrazeneca Ab|Blister pack, apparatus and method for manufacturing a blister pack and use of a blister pack|

---

US5788974A|1996-09-11|1998-08-04|D'amico; Steven A.|Helicobacter pylori treatment compliance pack|

---

DE29719070U1|1996-10-29|1998-05-14|Byk Gulden Lomberg Chem Fab|Blister for combination therapy|

---

JP2001504372A|1996-11-19|2001-04-03|ザプロクターアンドギャンブルカンパニー|COMPLIANCE PACKAGES AND METHODS TO IMPROVE OR ASSIST PATIENT COMPLIANCE WITH REGULATIONS OF COMPLEX DRUG|

---

US5848976A|1997-02-19|1998-12-15|Weinstein; Robert E.|Allergic rhinitis relief system and process|

---

US6564945B1|1997-07-14|2003-05-20|Robert E. Weinstein|Medication assemblage for use in sinusitis treatment regimens|

---

US6077530A|1997-07-28|2000-06-20|Weinstein; Robert|Analgesic dosage units for coordinated administration|

---

WO1999021556A1|1997-10-29|1999-05-06|J-Med Pharmaceuticals, Inc.|Antihistamine/decongestant regimens for treating rhinitis|

---

WO1999051214A2|1998-04-07|1999-10-14|Akzo Nobel N.V.|Progestogen-only contraceptive kit|

---

US6375956B1|1999-07-22|2002-04-23|Drugtech Corporation|Strip pack|

---

WO2001045636A1|1999-12-20|2001-06-28|Merck & Co., Inc.|Pharmaceutical kit|

---

US20050139506A1|2000-07-21|2005-06-30|Lorenzato Raymond M.|Medication distribution system|

---

US20020045184A1|2000-10-02|2002-04-18|Chih-Ming Chen|Packaging system|

---

US20020066691A1|2000-12-04|2002-06-06|Varon Steven C.|Therapy pack|

---

US6588180B2|2001-02-02|2003-07-08|R. P. Scherer Technologies, Inc.|Constricted neck blister pack and apparatus and method for making the same|

---

US6651816B2|2001-05-04|2003-11-25|Robert E. Weinstein|Antihistamine/decongestant regimens for treating rhinitis|

---

US20030168376A1|2001-12-19|2003-09-11|Rajneesh Taneja|Packaging system for separately storing and dispensing together separate medication components|

---

US20030111479A1|2001-12-19|2003-06-19|Rajneesh Taneja|Packaging system for separately storing and dispensing together separate medication components|

---

US20040064215A1|2002-08-05|2004-04-01|Greeven John C.|Pharmaceutical dispenser system|

---

US7017748B2|2003-01-17|2006-03-28|Weinstein Robert E|System and method to reduce uncertainty in procuring over-the-counter medication|

---

US7188728B2|2003-03-20|2007-03-13|Wade Everette Williams-Hartman|Child-resistant and senior-friendly blister card package|

---

US7905355B2|2003-03-20|2011-03-15|Key-Pak Technologies, Llc|Theft-resistant and senior-friendly packaging of consumer products|

---

EP1622817B1|2003-03-20|2011-10-26|Wade E. Williams-Hartman|Child-resistant and senior-friendly blister card package|

---

US7086532B2|2003-07-16|2006-08-08|Allergan, Inc.|Titration/compliance pack with increasing doses|

---

US7210580B2|2003-10-28|2007-05-01|Future Technology Ltd|Dispensing containers|

---

WO2005109948A2|2004-04-24|2005-11-17|Inrange Systems, Inc.|Universal medication carrier|

---

ITRM20040307A1|2004-06-23|2004-09-23|Sigma Tau Ind Farmaceuti|PACKAGE OF AT LEAST TWO DIFFERENT PRODUCTS TO SELL AND USE TOGETHER.|

---

US7243798B2|2004-08-04|2007-07-17|Fisher Clinical Services|System and a method for a V-indent blister opening cavity|

---

US7971414B1|2007-05-30|2011-07-05|Walgreen Co.|Multi-dose filling machine|

---

US20090202635A1|2008-02-08|2009-08-13|Stephen Michael Scott|Delivery System, Application, and Method|

---

BRPI0908718A2|2008-03-17|2019-09-24|Procter & Gamble|user customizable dosing system|US8123036B2|2004-10-01|2012-02-28|Edge Medical Properties, Llc|Pill assembly for pill packaging and delivery systems|

---

US20130299381A9|2004-10-01|2013-11-14|Edge Medical Properties, Llc|Dual dispensing tablet container|

---

US9334096B2|2004-10-01|2016-05-10|Edge Medical Properties, Llc|Multiple inspection system and method that inspects different medications|

---

US10435192B2|2011-05-16|2019-10-08|Edge Medical Properties, Llc|Multiple inspection system and method that inspects different medications|

---

US8789700B2|2004-10-01|2014-07-29|Edge Medical Properties, Llc|System and method for communicating and inspecting a multiple tablet order|

---

US9238518B2|2004-10-01|2016-01-19|Edge Medical Properties, Llc|Inspection system and method with a control process that inspects different medications|

---

US10315450B1|2006-10-24|2019-06-11|Edge Medical Properties, Llc|System and method for generating an integrated label for container housing multi-script pouches|

---

US9710866B2|2005-09-30|2017-07-18|Edge Medical, Llc|System and method for processing a multiple prescription order|

---

US20120305584A1|2011-06-06|2012-12-06|Omnicare Inc.|Administration methods and packagings for oral medications|

---

CA2864920C|2012-02-17|2021-10-12|Bernard Fresco|First-aid kit with backing member|

---

JP2015525093A|2012-05-22|2015-09-03|ザ プロクター アンド ギャンブルカンパニー|Personal air freshener|

---

US9511945B2|2012-10-12|2016-12-06|Aesynt Incorporated|Apparatuses, systems, and methods for transporting medications from a central pharmacy to a patient in a healthcare facility|

---

US10176735B2|2012-11-30|2019-01-08|Cvs Pharmacy, Inc.|Packaged medication assembly and associated method|

---

US9150119B2|2013-03-15|2015-10-06|Aesynt Incorporated|Apparatuses, systems, and methods for anticipating and delivering medications from a central pharmacy to a patient using a track based transport system|

---

US20140299490A1|2013-04-04|2014-10-09|The Procter & Gamble Company|Package for a Medicament|

---

KR20160033123A|2013-06-26|2016-03-25|스위스로그 이탈리아 에스.피.에이.|Support for a unit dose drug|

---

USD731171S1|2013-10-07|2015-06-09|Abbvie Inc.|Template for a prescription medicine container|

---

USD731782S1|2013-10-07|2015-06-16|Abbvie Inc.|Template for a prescription medicine container|

---

USD731783S1|2014-04-16|2015-06-16|Abbvie Inc.|Template for a prescription medicine container|

---

US9642773B2|2015-02-03|2017-05-09|Chiasma Inc.|Overlay for medication card|

---

KR20180075504A|2015-09-23|2018-07-04|리옥신 이노베이션 그룹, 엘엘씨|Flavonoid compositions and methods of use|

---

USD831330S1|2015-10-19|2018-10-23|Abbvie Inc.|Medication packaging combined with dispensing container|

---

JP1561139S|2016-01-25|2016-10-17|

---

US20170333291A1|2016-05-19|2017-11-23|Edge Medical Properties, Llc|Pill assembly for pill packaging and delivery systems|

---

USD930974S1|2018-03-22|2021-09-21|Abbvie Inc.|Child-resistant medication container|

---

US11052021B2|2018-03-22|2021-07-06|Abbvie Inc.|Medicine container, method of assembling the container, and method of dispensing the medicine from the container|

---

USD930973S1|2018-03-22|2021-09-21|Abbvie Inc.|Child-resistant medication container|

---

USD882243S1|2018-03-26|2020-04-28|Abbvie Inc.|Child-resistant medication container assembly|

---

EP3941421A1|2019-03-18|2022-01-26|Galderma Holding SA|Pharmaceutical packaging system and method of manufacturing same|

---

FR3100532B1|2019-09-10|2021-10-01|Neovia|COMPLEMENTARY FEED PACKAGING KIT|

法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-04-28| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2020-09-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US12/971,677|2010-12-17|

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US12/971,677|US8752704B2|2010-12-17|2010-12-17|Blister cards promoting intuitive dosing|

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PCT/US2011/065343|WO2012083109A1|2010-12-17|2011-12-16|Blister cards promoting intuitive dosing|

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