专利摘要:
The present invention provides a disposable dispensing device that supports optimal treatment for humans and other animals by conveniently providing, in a user-friendly manner with a storage stability, a complex dosing regimen requiring administration of a storage incompatible or non-uniformly administered component. It is about. The present invention is particularly useful for humans in need of special treatment, such as pregnant women, childbirth women and menopausal women.
公开号:KR20020038698A
申请号:KR1020027000885
申请日:2000-06-30
公开日:2002-05-23
发明作者:마크 에스. 헐메린;미첼 아이. 키르쉬네르
申请人:프란시스 비이. 자콥;드러그테크 코포레이션;
IPC主号:
专利说明:

Strip Pack {STRIP PACK}
[2] Physiological requirements change from person to person, even during the life of the same person. In addition, various conditions may affect physiological requirements. For example, a pregnant woman, a woman giving birth and a menopausal woman may require a lot of nutrition, treatment or treatment, but may require less, or even endurance, other nutrition, treatment or treatment.
[3] To meet the specific physiological requirements of humans and other animals, it is necessary to use complex routine treatment plans that require the administration of various bioactive substances simultaneously or separately throughout the day. In addition, complex routine treatment plans may require simultaneous administration of bioactive substances with storage incompatibilities. Storage incompatibilities exist between two or more substances when two or more substances cannot be formulated together in a single pharmaceutical formulation unit because they are negatively interacting or cannot be stored together in direct contact. do. In addition, this storage incompatibility cannot be formulated together in a single pharmaceutical formulation unit because the total amount of the formulation formulation of two or more substances may be difficult to swallow or at least reach a single formulation formulation unit that is not optimal for swallowing. It also exists between species or more substances. In addition, storage incompatibility also exists between those two or more substances in which at least one of the two or more substances is a prescription substance, and at least one substance is a non-prescription substance.
[4] In addition to the problem of simultaneous administration of such storage incompatible substances, complex routine treatment regimens also present problems that patients do not adapt well. Indeed, according to the medical literature, about 30% to 50% of all patients do not adapt to the physician's prescription. See Libre et al., P. 107, 1981 edition of The Core of Geriatric Medicine: A Guide for Student and Practitioners. Interviews with 178 elderly outpatients revealed that 59% of them had a mistake in their medication and a tentative serious error in an average of 2.3 patients, about 25% of the entire group. See `` The Medication Mistakes Made by Chronic Aged Patients '' in American Journal of Public Health, 1962 edition 52-2018, pages 29-29, published by Schwartz et al.
[5] In addition, a study investigating the inadequacy of patients who were recently discharged from emergency care facilities found that 50% of the patients had deviated from the prescription plan. See “Departures from Prescribed Drug Treatment After Discharge,” in 1976 Edition 2, page 686 of the British Mwdical Journal, published by Parkin et al. Moreover, there is evidence that drug treatment mistakes are a major contributor to the onset. See the study of the epidemiology of unfavorable drug reactions in the 1966 edition of Hopkins Hospital Hospital Newsletter, Seidl et al., Pp. 119, pages 299-315.
[6] In addition to the reduction of special consciousness, there are a wide range of factors that contribute to weakening the patient's adaptability, including the complexity of the treatment plan, the motivation of the fragile patient, the lack of sufficient knowledge of the patient, memory loss and other cognitive dysfunctions do.
[7] Disposable medicament containers for dispensing medicaments for use in improving patient adaptability have already been disclosed. One type of pack for dispensing medication is to arrange the medication in separate recesses on a flat card to form a blister package. An example of such a packaging can be found in U.S. Patent No. 4,295,567 to Knudsen, which discloses a pharmaceutical dispensing container containing two pharmaceutical formulation units, which are symptomatic treatments for respiratory tract disorders. The first of these formulated dosage units is indicated for weekly administration and is therefore non-sedation. The second of these formulated units is indicated for nocturnal administration and is therefore calm. Means of indication include recording the time period of the dosage form and the distinctive visible characteristics of the dosage form.
[8] U.S. Pat.No. 5,358,118 to Thompson et al. Describes blister packs with stepped edges for storage and dispensing units of drug administration, such as capsules, tablets, capsules or rapid dissolving drug forms. have. This invention consists of a base sheet and a substantially flat covering sheet. The base sheet includes a plurality of blister compartments and a plurality of steps along their edges, one step adjacent to each blister compartment. The nearly planar cover sheet is releasably sealed to the base sheet except for the extended edge portion, thus forming an edge peel tap. The edge release tabs are arranged like steps along the edges of the base sheet, so that the fingers can be continuously accessed to facilitate the operation of opening each blister compartment. The cover sheet is engraved with lines of weakening to separate each blister compartment from the blister package.
[9] US Pat. No. 5,325,968, in Soden, describes a tablet maintenance package designed to be safe for children by restricting access into the package. The user must complete many successive steps in order to access the medication. First, the user grips the trapezoidal section of the access tab to expose finger depression. The user then grips a cover covering the press, which extends over the medication. Finally, the user pulls this cover back to reveal the medication.
[10] U.S. Patent 4,958,736 in the name of Urheim describes a package for oral contraceptive tablets. This package contains four rows with seven tablets per line. Three adjacent rows contain actual contraceptive tablets, while the fourth row contains placebo tablets. A cut line is provided between the placebo tablet row and the actual tablet row, thus allowing the distribution of 21 and 28 day oral contraceptive formulations using a single package.
[11] U.S. Patent No. 5,695,063 to Roulin et al. Describes a blister pack for pharmaceuticals, the blister pack comprising a base having a plurality of recesses surrounded by a shoulder. A cover foil is attached to the shoulder. Detachable contents, such as tablets, capsules or ampoules, are located in the recesses and can be separated by pressing the recesses to pierce the cover foil or remove the cover foil on the recesses. The blister pack features a movable lid or clamp element covering at least one recess, the clamp element is arranged to slide over the cover foil, and the clamp element is at least one of the cover foil perforated or peeled off. Re-close the recess or re-close at least one lid left untitled and without lid when filling.
[12] U.S. Pat. No. 5,788,974 in the name of D'Amico et al. Describes a drug dispensing container. This drug dispensing container facilitates the eradication / treatment of Helicobacter pylori and adaptation to subsequent related gastrointestinal diseases related to the infection of the bacterium, resulting in improved treatment resulting in improved treatment. A plurality of dosage unit units are maintained to aid in adaptation using repeated dosing regimens for a period sufficient to alleviate. The dosage form unit may be an antibiotic, an anti-microbial, or a combination of symptoms relief.
[13] US Pat. No. 4,889,236 to Bartell et al. Describes a robust, three-part blister pack pharmaceutical package in the form of a credit card. This medication package is particularly useful for dispensing medications that must be administered according to a daily schedule on a calendar. This package has a separate structure and can be conveniently stored in a purse.
[14] US Pat. No. 5,624,036 to Roulin et al. Describes blister packs without additional packaging of medicaments. The pack includes a base having a plurality of recesses surrounded by a shoulder and a cover foil attached to the shoulder. The recesses contain detachable contents and can be detached by pressing the recesses or by removing the cover foil on the recesses. The pack includes an accompanying leaflet that represents a portion of the blister pack and is located within a limited range of the blister pack, for example a compartment in the base or a gripping portion on one side of the blister pack.
[15] U.S. Pat.No. 5,310,060 in Bitner's name describes a novel tamper-evident, child-protective blister package for pharmaceuticals and non-pharmaceuticals that is difficult to open to children or unhealthy adults. have. Blister packaging has a pull tab designed to be pulled away from and not facing the article receiving pocket, which may be present in the package, so that a child or user of the blister pack may be intentional or accidental. Only one item receiving pocket is accessible at a time. The blister packaging of this invention is an attractive and inexpensive packaging for the commercialization of drugs and other articles constructed in a manner that is easy for mass production.
[16] This type of drug dispensing package is known in the art to have the medications arranged separately in individual recesses on the flat card to form a blister pack, which can be inserted back into the protective container, otherwise there is an additional settling distribution of the medication. have. An example of such a packaging can be found in US Pat. No. 4,376,849 to Leonard et al. This patent describes a method and apparatus that aids in the storage and dispensing of calendar-oriented drugs. The apparatus includes a carrier having a plurality of tablet-stores arranged in rows. The reservoirs are appended with numerical and / or alphanumerical representations such that each reservoir is associated with only one month to one month of the calendar. You can add one or more additional repositories in different columns to the same calendar date. Corresponding markings on opposite sides of the carrier may aid in the decision to open the reservoir. The package may also provide a visual indication of calendar dates for tablets not used by the patient, in this way providing the patient's adaptation information to the physician's prescription of such medication. This dispensing device is particularly suitable for the administration of prescription medications by date for the treatment of menopausal symptoms.
[17] US Pat. No. 5,265,728 to Allendorf et al. Describes a structure for holding blister pack tablets. The structure includes a container having at least a front cover and a rear cover, wherein a blister pack is arranged sandwiched observably through the window of the front cover between the front cover and the rear cover. The blister pack includes an indication on the surface indicating the order of the tablets to be administered and the container includes a pointer identifying the first tablet in the row of tablets to be consumed. Preferably, the container comprises a daily calendar in the form of a loop or cylinder that is movable relative to the container so that the user or prescriber can select the desired starting phrase. The loop or cylinder may be locked in its selected position. In two embodiments of this invention, the front and rear lids are pivoted about each of the front and rear covers to conceal the blister pack until a dose of tablet is needed.
[18] Kelly Patent, US Pat. No. 4,817,819, describes a tablet vessel having a cover and a sliding tray. This container is used to dispense the conception tablets for a 21 or 28 day cycle. Normally, the tray does not slide completely out of the cover and thus becomes stable with respect to the cover when opened. This case is similar to the cosmetic compact, and the conception tablets stored in the blister pack can be reused once used and the new blister pack can be easily inserted.
[19] US Pat. No. 5,377,841, in the name of Varon, describes a sleeping therapeutic package. The package includes a box with a card with medication in the form of a tablet or capsule and audiogenic recording for sleep induction. Some of the drugs are sleep-inducing drugs, and some are placebos.
[20] US Patent No. 4,889,238 to Bachelor's name discloses a drug package that improves adaptability to a treatment plan. The treatment plan includes a plurality of medications that are administered to the patient at the prescribed turn and at specific intervals. This package typically contains a number of blister cards of constant planar dimensions. Blister cards contain medications in the order of cards, cards, and individual cards. The blister card is arranged in a stacked arrangement in which the major dimensions are almost horizontal and the order in which they are first used is placed at the top. Also included is a base for storing a stacked arrangement of blister cards. The base allows direct and unobstructed access to the topmost blister card and limited access only to the edges of the blister card. A lid is used to cover the base, which can be moved to an open position to allow access to the top blister card. Each blister card typically includes an indication of the order and sequence when the contents of the individual blister cavity are consumed.
[21] U.S. Patent No. 3,397,671 to Hartman et al. Discloses a re-dispenser such as a tablet. The dispensing device comprises a holder, a carrier to be held in the holder, a plurality of tablet pockets to be opened individually on the carrier, indicator means added to the holder to indicate a period of consumption of the tablets in each pocket and to be selectively positioned relative to the carrier. Include.
[22] US Patent No. 5,109,984 to Romick's name describes a reusable plastic drug dispensing container for dispensing a medicament for a blister pack. The container includes a top, a bottom, and a retention frame molded from an integral plastic and hingedly connected to each other.
[23] Pharmaceutical dispensing packages are also known in the art, in which the drugs are arranged in separate recesses of the device rather than in a single use. An example of such a packaging can be found in US Pat. No. 4,749,085 to Denney. This patent describes a rectangular top open thin tray with sidewall covers. The tray has a display portion at the top that specifies each date of the weekly date so as to be spaced at equal intervals. A separate compartment or tablet box set for each day of the weekly date in the tray is added to each designated date of the weekly date and remains rubbed and removable in place in the tray, so that the tablet box set is separated from the tray and individually Can be removed, such that the user can conveniently retain the prescribed medication for a given date irrespective of other days of the weekly date.
[24] US Pat. No. 4,473,156 to Martin, describes an apparatus for accurately selecting, storing and dispensing a variety of different tablets at preselected time intervals, such as breakfast, lunch, dinner and night. The apparatus also includes a separate purifying vessel for each unique variety of tablets to be dispensed. Each tablet vessel is identified by color (s) that are distinguished to indicate the time interval at which the tablet contained therein will be dispensed. For example, in the morning each recess may be identified as red, at least yellow at lunch, at least blue at dinner, and at least black at night. Therefore, any particular container can be identified with at least one color and less than four colors. The tablet tray includes a plurality of tablet maintenance zones arranged in rows so as to be identified with each date of the columned weekly date. Each row represents a time interval such as breakfast, lunch, dinner and night. Each tablet maintenance zone of the morning row is red, the row representing lunch is yellow, the evening is blue, and the night is black. The tray is loaded by placing one tablet from each container into each of the zones of the same color as one of the colors identifying the container. A sliding panel is provided as a cover for each row, and the patient can access the appropriate medication by opening the appropriate zone at the appropriate time interval.
[25] Will's U.S. Patent No. 4,593,819 describes a rectangular tray configuration with an array of top open zones. This composition maintains a supply of medication arranged daily and by dosing time. The tray is coupled to a support base having a facility for storing a medicine container. The tray is provided with a case, which includes a cover to move the tray without the risk of the tablets being removed from the individual zones.
[26] U. S. Patent No. 4,039, 080 to Cappuccilli describes a tray having individual zones holding pills, capsules, or similar solid medications. Each zone is rectangular in plan view and arranged in a rectangular arrangement or seven rows and a plurality of columns. The tray can be loaded with a week's worth of medication, and each patient selects each zone according to the indication adjacent to each row representing the date of the weekly date, and the indication adjacent to each column representing the date's time. . A lid or cover is coupled to the wall means forming each zone to isolate the zones from each other when in the closed position. The inner surface of the zone is preferably rounded on at least one side to facilitate separation of the tablets.
[27] The above mentioned holders, dispensers and pharmaceutical packaging are disadvantageous in many respects. Importantly, none of the cited documents mentioned above is a convenient, simple, and effective method, particularly when the storage nonconforming material is easily and simultaneously administered when the storage nonconforming material is taken as part of a complex and ordered routine treatment plan. It is not provided. In addition, none of the above-mentioned documents specifically mentions the manner of easily administering the prescribed and unprescribed substances simultaneously as part of a complex treatment regimen. Moreover, none of the aforementioned documents addresses the problem of supporting optimal treatment for humans and other animals. Therefore, there is a need for simple, inexpensive and convenient means to support appropriate treatment for humans and animals, and in particular for optimal support for humans and animals in need of special treatment.
[1] The present invention relates to disposable dispensing devices and methods for providing nutrients and / or therapeutics to humans and other animals. In particular, the present invention relates to a storage stable blister pack having a plurality of recesses that is conveniently constructed to provide a dosing regime that requires storage incompatibility or administration of a non-uniformly administered component.
[42] 1A is an elevational view of a disposable dispensing device illustrating specific display markings in accordance with an embodiment of the present subject matter.
[43] 1B is a cut away elevational view of one intended area.
[44] 1C is a cut elevational view of one intended area after removing the backing.
[45] FIG. 2 is a perspective view of a disposable dispensing device showing the arrangement of one soft gelatin capsule and one tablet (pill) for simultaneous administration in accordance with an embodiment of the present subject matter.
[46] 3 is a perspective view of a storage container for storing a plurality of blister packs in accordance with an embodiment of the present subject matter.
[47] 4 is an elevational view of a disposable dispensing device illustrating a specific display marker with a pull tab in accordance with an embodiment of the present subject matter.
[48] FIG. 5 is an elevation view of a disposable dispensing device showing the arrangement of one soft gelatin capsule and three tablets for simultaneous administration in accordance with an embodiment of the present subject matter.
[49] 6 is a perspective view of a storage container for storing a plurality of blister packs in accordance with an embodiment of the present subject matter.
[50] 7A is an elevational view of a disposable dispensing device showing the arrangement of one soft gelatin capsule and one tablet for simultaneous administration in accordance with an embodiment of the present subject matter.
[51] FIG. 7B is a perspective view of the disposable dispensing device in which the detachable seal is partially separated. FIG.
[52] 8A is a perspective view of another embodiment of a disposable dispensing device showing the arrangement of one soft gelatin capsule and one tablet for simultaneous administration in accordance with an embodiment of the present subject matter.
[53] FIG. 8B is a perspective view of another embodiment of a disposable dispensing device with detachable seal means partially separated; FIG.
[28] The subject matter of the present invention relates to a storage stable disposable dispensing device and method that supports the optimal treatment while overcoming the shortcomings of currently available pharmaceutical packaging simply, effectively, conveniently and cost-effectively.
[29] One embodiment on the subject of the present invention provides for optimal treatment in animals by increasing the adaptability to complex dosing regimens, which may include prescription and non-prescription substances, during certain intervals of administration, thereby facilitating simultaneous administration of storage incompatible substances. A supporting storage stability disposable dispensing device comprising: a blister pack having a plurality of separate regions defining at least a first recess and a second recess, respectively, and the first recess A first dosage unit comprising a first bioactive material and containing a second bioactive material, a second dosage unit comprising a second recess and comprising a second bioactive material Corresponding to each of the separated areas, provided to the blister pack to indicate on which date the dosage unit should be administered, A date marker that can increase patient adaptability, wherein the combined dosing regimen requires simultaneous administration of the first and second bioactive materials, wherein the first bioactive material is incompatible with the second bioactive material Wherein the first and second recesses independently block intimate access of the first and second dosage form units to prevent interaction between the first and second bioactive materials. Promote simultaneous administration of the active substance while providing stability.
[30] Another embodiment of the subject matter of the present invention relates to a storage stable disposable dispensing device that increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance, The device comprises a storage stable blister pack having at least one row of a plurality of discrete regions forming at least one recess, and at least one recess of the at least one discrete region and containing non-prescription material A second pharmaceutical formulation unit occupying at least one recess of said at least one separate region and containing a prescription substance, said second formulation being arranged in said blister pack adjacent to said first formulation formulation unit A dosage form unit and a date marker provided to the blister pack corresponding to the at least one discrete region; Each of the separated regions is provided with a seal which is independently accessible, detachable or breakable.
[31] Another embodiment of the subject matter of the present invention is a storage stable disposable dispensing device which increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance. The apparatus comprises a storage stable blister pack having at least one row of a plurality of discrete regions forming at least one recess, and at least one recess of the at least one discrete region and containing non-prescription material; A second formulation which occupies at least one recess of said at least one separate region and contains a prescription substance, said second formulation being arranged in said blister pack adjacent said first formulation formulation unit A dosage unit and a date marker provided to the blister pack corresponding to the at least one discrete region, wherein The rows of the plurality of separate regions are provided with seals that can be independently accessed, separated or destroyed.
[32] Another embodiment of the subject matter of the present invention is a storage stability disposable dispensing device which increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance, The device comprises a storage stable blister pack having at least one row of a plurality of discrete regions forming at least two recesses, and a non-prescription material occupying the first recess of the first discrete regions. A second dosage form unit, a second dosage form unit occupying a second recess of the first separated region and containing a prescription substance and arranged in the blister pack adjacent to the first dosage form unit; and A date marker provided to the blister pack corresponding to at least one of the separated regions, wherein each of the separated regions is independently accessible, separated Or breakable seal means.
[33] Another embodiment of the subject matter of the present invention is a storage stable disposable dispensing device which increases the patient's adaptability to a routine treatment plan through proximity and joint access to a plurality of therapeutic ingredients to be administered simultaneously. Is a blister pack having at least one row of a plurality of discrete regions each forming two recesses, and a first formulation occupying a first recess of the first discrete region and containing a first therapeutic substance. A formulation unit, a second formulation unit that occupies a second recess of the first separated region and contains a second prescription substance, and the blister pack arranged adjacent to the first formulation unit A second dosage form unit and a date marker provided in said blister pack corresponding to at least one of said separated regions, each of said separated regions being a poison Typically it includes an access, separate or destructible sealing means (seal).
[34] Another embodiment of the subject matter of the present invention is a storage stable disposable dispensing device which increases the patient's adaptability to a routine treatment plan through proximity and joint access to a plurality of therapeutic ingredients to be administered simultaneously. Is a blister pack having at least one row of a plurality of discrete regions each forming two recesses, and a first formulation occupying a first recess of the first discrete region and containing a first therapeutic substance. A formulation unit, a second formulation unit that occupies a second recess of the first separated region and contains a second prescription substance, and the blister pack arranged adjacent to the first formulation unit A second dosage form unit and a date marker provided in said blister pack corresponding to at least one of said separated regions, each of said separated regions being a poison Typically it includes an access, separate or destructible sealing means (seal).
[35] Another embodiment of the subject matter of the present invention is a storage stability disposable dispensing device which increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance, The device comprises a blister pack having at least one row of a plurality of discrete regions forming at least one recess, at least one recess of the at least one discrete region and comprising a hormone replacement agent, a contraceptive agent, A first dosage form unit containing a prescription substance selected from the group consisting of osteoporosis agents, chemotherapeutic agents, anti-infective agents, analgesics, steroids, appetite reducing agents, weight loss agents, smoking cessation agents, cholesterol reducing agents, and combinations thereof, Occupies at least one recess of said at least one separate region and contains a prescription therapeutic substance; And a second preparation unit arranged in the blister pack adjacent to the first preparation unit, and a due date provided in the blister pack corresponding to at least one of the separated regions, wherein the separation Each of the zones provided has seals that are independently accessible, detachable or breakable.
[36] Another embodiment of the subject matter of the present invention is a disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen to facilitate the administration of heterogeneous dosages of bioactive materials. Is a blister pack having at least two rows of a plurality of separate regions, each forming a first recess in which each of the separated regions is adapted to receive a first dosage form unit and having a first visual marker A first row of separate areas, and a second row of separate areas each forming a first recess each adapted to receive a second formulation unit and having a second visual marker, One dosage form unit has an amount greater or less than the second dosage form unit by weight of the bioactive agent.
[37] Another embodiment of the subject matter of the present invention is a disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen to facilitate the administration of heterogeneous dosages of bioactive materials. The apparatus comprises a blister pack having at least two rows of a plurality of discrete regions, each of the separated regions respectively forming a first recess adapted to receive a first dosage unit and having a first visual indication A first row of separated zones, said separated zones comprising a second row of separated zones each forming a first recess adapted to receive a second dosage form unit and having a second visual marker, wherein The first preparation unit has a larger volume than the second preparation unit, has a smaller volume than the second preparation unit, and Phase is different.
[38] Another embodiment of the subject matter of the present invention is a method of supporting optimal treatment for an animal by increasing the adaptability to a complex dosing regimen to promote simultaneous administration of a storage incompatible material, the method comprising: Providing a blister pack having a plurality of discrete regions forming at least a recess, providing a second dosage form unit occupying said first recess and consisting of a first bioactive material; Providing a second formulation formulation unit occupying two recesses and composed of a second bioactive material, and providing a date marker on the blister pack corresponding to each of the separated regions so that the formulation formulation unit is on which date Increasing the patient's adaptability to the combined dosing regimen by indicating whether the dose should be administered and indicated by the due date marker. In case the non-prescription therapeutic substance and the prescription therapeutic substance of the blister pack together with the animal, wherein the combined dosing regimen requires simultaneous administration of the first and second bioactive substances and wherein the first The bioactive material has incompatibility with the second bioactive material, and the first recess and the second recess independently block close access to the first preparation unit and the second preparation unit to prevent the first preparation. And promoting the simultaneous administration of the active material while providing storage stability by preventing interaction between the second bioactive material.
[39] Another embodiment of the subject matter of the present invention is a method of increasing the patient's adaptability to a prescription therapeutic material, the method comprising providing a blister pack having at least one row of a plurality of discrete regions; Providing a first dosage form unit containing a non-prescription substance in a recess of one separate region, and providing a second dosage form unit containing a prescription therapeutic substance in a recess of the blister pack. Wherein the second preparation unit is disposed adjacent to the first preparation unit, providing a mark on the blister pack corresponding to the first and second preparation unit, And administering the prescription therapeutic substance and the non-prescription substance of the blister pack together to the animal at the time indicated by.
[40] Another embodiment of the present invention provides a method of increasing patient adaptability to a routine treatment plan, the method comprising the steps of providing a blister pack having at least one row of a plurality of discrete regions; Providing a first dosage form unit containing a prescription substance in the recess of the filled area, and providing a second dosage form unit containing a non-prescription therapeutic substance in the recess of the blister pack Two preparation formulation units are disposed adjacent to the first preparation formulation unit, providing a mark on the blister pack corresponding to the first and second preparation formulation units, and marked by the marking At a time, administering the non-prescription therapeutic substance of the blister pack and the prescription substance together to an animal.
[41] Further features and advantages of the invention are set forth in the description of the presently preferred embodiments and will be apparent from this description.
[54] As used herein, the term "animal" refers to humans, mammals, or other animals.
[55] The term "biologically-active substance" refers to a drug, active therapeutic substance, metabolite, drug, hormone, steroid, vitamin, fatty acid, amino acid, sugar, carbohydrate, polypeptide or any substance Or any substance that affects substances, anatomical tissue, or any substance that affects physiological function, an impact on an external influence on an animal or its metabolites, and as used herein, "active substance", "treatment" Substance "," agent "," active agent "," active therapeutic agent ", It means "drug", "medication", "medicine", "medicant" and the like, without limiting it.
[56] The term “complex dosing regimen” means the systematic administration of a plurality of dosage form units at a specified time during a day, including the administration of a plurality of dosage form units that are potentially confused to a patient. There is no.
[57] The term "uneven dosing" or unevenly dosed "means a dose of a bioactive substance, in which case each dose after the initial dose is either patient or health / medical Different amounts of bioactive material compared to previous doses, without any limitation, including conventional external administration of individual dosages by a specialist or internal administration via controlled variable or pulsed release systems or combinations thereof well known to those skilled in the art. The term "dose" refers to the individual release of a substance into body tissue.
[58] The term "shelf stability" or "storage stability" refers to the stability of a material that withstands changes or deterioration of its chemical, physical or biological properties when it is in use for at least six months.
[59] The term "storage-incompatible substance" means a substance or substance that cannot be formulated together in a single dosage unit unit and that cannot be stored together in direct contact because of negative interactions. By a total amount of the formulation is meant a substance which cannot be formulated together in a single formulation form unit as it may lead to a single formulation unit that is too large to swallow. The term also refers to a variety of materials that can be stored in direct contact, but one of these materials is preferably prepared in the form of a pharmaceutical formulation that is incompatible or incompatible with the materials of the remaining species. The term storage incompatibility may also mean two or more substances in which at least one substance is a prescription substance and at least one substance is a non-prescription substance.
[60] The term "storage imcompatibility" means a state that exists between a variety of storage incompatibilities as defined above.
[61] The device of the present invention increases storage adaptability to complex dosing regimens, thereby facilitating the administration of storage incompatible materials, specifically, the simultaneous administration of storage incompatible materials, thereby providing storage stable disposable distribution to support animals for optimal treatment and / or nutrition. Device. The device contains a variety of blister packs. This blister pack is characterized by a plurality of single compartments referred to hereinafter as "recesses". Each recess contains a dosage form unit and isolates it from the other dosage form unit. In this way, the bioactive material of each pharmaceutical formulation unit is not in contact with the bioactive substance of the other pharmaceutical formulation units, even though other formulation formulation units are in close proximity to the blister pack. This device facilitates the simultaneous administration of a storage incompatible material required by a complex dosing regimen that specifically supports an optimal treatment when it includes an indication of the date and time corresponding to the recess.
[62] 1A shows a novel disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen and promoting concurrent administration of a storage incompatible material, according to one embodiment of the present subject matter. Is shown. In FIG. 1A a blister pack 10 is shown in elevation, with the lid foil 11 coupled to the base 14 at the shoulder 12. The lid foil 11 covers the plurality of recesses 15. Two adjacent recesses are located in separate regions 19, respectively. Each separated area is separated from other separated areas by the perforated edge 13. In each individual recess there is a dosage form unit 16, 17. In the region of the shoulder 12, the lid foil 11 is bonded to the base 14 by, for example, sealing or adhesive bonding (not shown). The recesses 15 are arranged in four rows and seven columns. The two inner rows are separated by sequentially marked strips 18. The inner vertical edge of each separated region is bounded by sequentially marked strips of strips. Each due date marks the day of the week. Within each row range, the two formulation recessed formulation units in separate regions contain the bioactive substance and the bioactive substance having storage incompatibility, respectively, in the formulation formulation units of the remaining recesses in the separated region. For example, the dosage form unit 16 contains a bioactive material having storage incompatibility with the dosage form unit 17. A visual marker 20 is provided in each separate area to indicate the time of administration.
[63] FIG. 1B is a cutaway view of one of the plurality of discrete regions described in FIG. 1.
[64] FIG. 2 shows a novel disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen, thereby facilitating simultaneous administration of storage incompatible substances, according to one embodiment of the invention. 2 shows a blister pack 30 in a perspective view. This blister pack 30 has a plurality of recesses 31. These recesses 31 are arranged in two rows and five columns. In each individual recess there is a dosage form unit 32, 33. The dosage form unit in each recess in one row is a tablet 32. The dosage unit in each recess of the remaining rows is a soft gelatin capsule 33. Thus, in each row, the formulation formulation units of the two recesses in the separate regions each contain the bioactive substance and the bioactive substance having storage incompatibility in the formulation formulation units of the remaining recesses in the separated regions. For example, the dosage form unit 32 contains a bioactive material having a storage incompatibility with the bioactive material of the dosage form unit 33.
[65] 3 shows a storage container 40 for long term storage of a plurality of blister packs 30 as described in FIG. The storage container 40 also includes a sign 42 for identifying the product. Inside or outside the container, a method of using the product (not shown) may be provided.
[66] 4 shows a modified blister pack 50 that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen to facilitate simultaneous administration of storage incompatible materials, in accordance with an embodiment of the present invention. have. In FIG. 4, a blister pack 50 is shown in elevation, with the lid foil 51 coupled to the base 54 at the shoulder 52. The lid foil 51 covers the plurality of recesses 55. Two adjacent recesses are located in each separate area 59. Each separated area is separated from the remaining separated areas by the puncturing edge 53. Within each individual recess is a formulation unit 56, 57. In the region of the shoulder 52, the lid foil 51 is bonded to the base 54 by, for example, sealing or adhesive bonding (not shown). These recesses 55 are arranged in four rows and seven columns. The two inner rows are separated by sequentially marked strips 58. Each due date signifies the day of the week. Within each row, the two recessed formulation formulation units in separate regions each contain the bioactive substance of the formulation formulation units in the remaining recesses and the bioactive substance having storage incompatibility. . Within each row, separate pull tabs 59 respectively cover the lid foil 51 on the lid foil side opposite the base 54 of the zone in each of the separate regions. It extends beyond the outer boundary of the base. In the region of the shoulder 52, the lid foil 51 is bonded to the pulling tam 59, for example by sealing or adhesive bonding (not shown). In this way, at the appropriate time, the pull tab can be peeled off the foil covering each immediately adjacent recess containing the dosage form unit for simultaneous administration as depicted in FIG. 4.
[67] FIG. 5 shows a novel disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen, thereby facilitating simultaneous administration of storage incompatible substances, according to one embodiment of the invention. 5 shows a blister pack 70 in a perspective view. This blister pack 70 has a plurality of recesses 71. These recesses 71 are arranged in two rows and two columns. Each individual recess has a dosage form unit 72, 73. The dosage form unit in one recess is tablet 72. The formulation unit in each of the remaining recesses is a soft gelatin capsule 73. Thus, in separate blister packs, the dosage form units in one row of recesses contain the bioactive material with storage incompatibility with the bioactive material of the dosage form units in adjacent recesses. For example, the dosage form unit 72 contains a bioactive material having storage incompatibility with the dosage form unit 73.
[68] FIG. 6 shows a storage container 80 for long term storage of a plurality of blister packs 70 as detailed in FIG. 5. This storage container 80 also includes a sign 82 for identifying the product. A method of using the product (not shown) may be provided inside or outside the container.
[69] 7A and 7B show another embodiment of a novel disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to the combined dosing regimen to facilitate simultaneous administration of storage incompatible materials.
[70] 7A shows a blister pack 90 in a perspective view. This blister pack 90 is divided into an AM section for the morning formulation and a PM section for the afternoon formulation.
[71] The AM section of this blister pack 90 has a tab 91 and two recesses 92 and 94. This recess 92 contains a tablet 96 made of a bioactive material and the recess 94 contains a tablet 98 made of a bioactive material. Tablets 96 of bioactive material have storage incompatibility with tablets 98 of bioactive material. Thus, by storing tablets 96 and 98 in separate recesses 92 and 94, tablets 96 and 98 of bioactive storage incompatible materials are prevented from interacting with each other.
[72] The PM section of the blister pack 90 has a tab 99 and two recesses 100, 102. One recess 100 has a tablet 104 made of a bioactive material and the other recess 102 has a soft gelatin capsule 106 made of a bioactive material. The tablet 104 of bioactive material has a storage incompatibility with the soft gelatin capsule 106 of bioactive material. Thus, by storing the tablet 104 and the soft gelatin capsule 106 in separate recesses 100 and 102, the tablet 104 and the soft gelatin capsule 106 of the bioactive storage incompatible material interact with each other. I can't.
[73] FIG. 7B shows a blister pack 90 with detachable seals 108 partially separated using tabs 99 located in the center of the blister pack 90. Once the detachable seal 108 has been separated, the tablet 104 and soft gelatin capsule 106 may be separated from each of the recesses 100 and 102 [Note: FIG. 7B shows only the tablet 104. Depicted as separate].
[74] 8A and 8B show another embodiment of a novel disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen to facilitate simultaneous administration of storage incompatible materials.
[75] The blister pack 110 is shown in perspective view in FIG. 8A. The blister pack 110 is divided into an AM section for the morning formulation and a PM section for the afternoon formulation.
[76] The AM section of this blister pack 110 has a tab 112 and two recesses 114, 116. Recess 114 includes a tablet 118 made of a bioactive material and recess 116 also includes a tablet 120 made of a bioactive material. Tablet 118 of bioactive material has a storage incompatibility with tablet 120 of bioactive material. Thus, by storing tablets 118 and 120 in separate recesses 114 and 116, tablets 118 and 120 of bioactive storage incompatible materials are prevented from interacting with each other.
[77] The PM section of the blister pack 110 has a tab 122 and two recesses 124, 126. The recess 124 contains a tablet 128 made of a bioactive material, while the recess 126 contains a soft gelatin capsule 130 made of a bioactive material. The tablet 128 of the bioactive material has a storage incompatibility with the soft gelatin capsule 130 of the bioactive material. Thus, by storing the tablet 128 and the soft gelatin capsule 130 in separate recesses 124 and 126, the tablet 128 and the soft gelatin capsule 130 of the bioactive storage incompatible material interact with each other. You won't be able to.
[78] 8B shows a blister pack 110 with a detachable seal 132 partially separated using a tab 122 located in the center of the blister pack 110. Once the detachable seal 132 is separated, the tablet 128 and soft gelatin capsule 130 may be separated from each of the recesses 124, 126.
[79] The disposable dispensing device can be arranged in a wide variety of configurations without limitation. In general, the apparatus includes a blister pack having at least one row having a plurality of discrete regions, each region forming at least one recess. If a suitable blister pack device is intended to facilitate simultaneous administration of components that cannot be brought into direct contact for long term storage, this pack device may be used. Thus, each recess is structured to receive only one bioactive material or only one pharmaceutical formulation unit with a plurality of storage incompatible materials.
[80] Each separated region may have independent separate or breakable seals. Once sealed, each recess is wet resistant and is particularly important for protecting materials produced by freeze-drying or lyophilization. The sealing surfaces of the separated areas are individually bent or vulnerable by independent sealing means, so that the contents in one area can be easily obtained without disturbing the sealing surfaces of the adjacent areas. At the same time, the device is robust enough to protect the contents from physical stresses, in particular stresses which are likely to occur during transport.
[81] Blistuck packs of the present subject matter can be prepared by well known techniques and readily available to those skilled in the art. Various types of blister packs can be used without limitation. For example, one type of blister pack that can be used is a push-through pack. This push pull pack is such a pack, for example, in which the lid material is aluminum foil or aluminum foil laminate. Aluminum foil is the preferred material for the lid of a blister pack when the thickness of the material used requires a relatively small force to destroy this material. Therefore, the production energy is low and aluminum inherently exhibits no elasticity. The base of the blister pack can be made of plastic, such as PVC, polyamide, polyolefin, polyester and plastics such as at least one of these materials and, if desired, laminates with aluminum foil or multiple layers of material. Another blister pack features a base covered by a lid foil. This lid foil can cover the entire base area and a line of weakness is provided to the area of each recess depending on the application, or each recess can be covered with a separate lid segment. Within the line of weakness, or on each lid segment, there may be a gripping tab through which individual recesses may be exposed by gathering behind the lid segment. The base and lid may be any of the materials described above, whereby a plastic laminate may be used for the lid material.
[82] The base of the blister pack may be embossed, deep drawn, or a vacuum formed base from plastic, plastic laminate, plastic / paper laminate or plastic / metal foil laminate. Unlimited representative suitable plastics for this base are films and film laminates containing PVC, polyamides, polyolefins, polyesters, polycarbonates and combinations thereof. The base may also be characterized by a barrier layer against gases and vapors. Such a barrier layer may be a metal foil, such as an aluminum foil embedded in a plastic laminate or, preferably, a ceramic layer or a metal layer embedded between two plastic layers. Ceramic layers can be prepared by depositing these materials on plastic substrates by evaporating various metals, oxides and nitrides of aluminum, silicon and other metals, and various semimetals in vacuum. This method is known as chemical vapor deposition and physical vapor deposition or sputtering. The ceramic layer preferably comprises aluminum oxide or silicon oxide, and may be a mixture of various oxides, if necessary, mixed with a metal such as silicon or aluminum. The metal layer may be formed by evaporating the metal in vacuum to deposit the metal on the plastic substrate, and the aluminum layer may be mentioned herein as a representative example. The plastic substrate may be a plastic film or plastic base made of the above-mentioned plastic. In general, the lid material for the push-out pack is aluminum foil or laminate containing aluminum foil. It has also been proposed to replace aluminum foil with plastics that exhibit low elasticity and poor draw properties. Such plastics can be obtained when a large amount of filler is added to the plastic. The last mention makes it possible to obtain wastes which are easily classified, such as mixtures of metals and plastics. Plastics and plastic laminates can also be used for blister packs that strip off the lid material.
[83] The base is usually characterized by having 4 to 28 recesses in the form of cups or dishes, but is not limited thereto. These recesses can be surrounded by a shoulder, which shoulders together form an interconnected flat plane. The base is made, for example, as an endless strip with the contents in the recess, and in particular is combined with a lid material in the form of a lid foil similar to that of the endless strip. This lid foil completely covers the base and is bonded to the base at the shoulder, for example by sealing or adhesive bonding. This lid foil may be sealed or adhesively bonded to the shoulder over the entire area, or such sealing or bonding may be made in part by selecting a special sealing tool or bonding pattern that is suitable for the purpose. Then, for example, an infinite strip of each capped base portion can be cut to the desired size. This can be done for example using a stamping tool. At the same time, the blister pack can have an appearance or can be provided with a vulnerable portion in the lid material or base so that the blister pack can bend or form a lid segment, thereby facilitating the separation of the lid segment and the contents. It can be done.
[84] Certain formulation forms and combinations thereof are contemplated by the present invention. Examples of such pharmaceutical formulation forms include, but are not limited to, chewable tablets, rapid dissolving tablets, effervescent tablets, reconstituted powders, elixirs, liquids, solutions, suspensions, emulsions, tablets, multilayer tablets, bilayer tablets, capsules , Soft gelatin capsules, hard gelatin capsules, caplets, lozenges, beads, powders, granular materials, dispersible granular materials, cachets, douche, suppositories, Creams, topical, inhalants, implants, storage implants, dragees, ampoules, ingestibles, injectables, infusions, medical rods, liquids, foods, nutritional foods , Functional foods, yoghurt, gelatin, cereals, cereal coatings, animal foods, or combinations thereof. The preparation of any of the formulation forms described above can be carried out by well known methods and techniques and can be readily used by one of ordinary skill in the art.
[85] The date marker is integrated into the blister pack of the present invention. This date mark may take a variety of forms, with no limitation. This due date marker corresponds to at least two separate recesses. For example, the date marker is not limited, but may be a specific date of the week, such as Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday, or an abbreviation of such date, or a specific date, or one, two, three, etc. It may also be a continuous date in general. The date marker may be indicated on another part of the blister pack or directly on the formulated unit.
[86] Visual markers may also be incorporated into the blister pack of the present invention. This visual marker can take any form without limitation. This time mark corresponds to at least two separate periods, but may correspond to any number of individual periods without limitation. For example, this time mark indicates without limitation the general time of the date corresponding to each of the separated areas or the specific time of the date corresponding to each of the separated areas. An unlimited representative general view of the date can be any of the following: AM, PM, morning, afternoon, evening, day, night, day, night and combinations thereof. Each individual row or column of the blister pack of the present invention may indicate the time of day, respectively, such as for example, AM and PM doses of the drug. Each separate region of the blister pack of the present invention may be color coded for visual marking. This blister pack may further include a key that defines or describes the color code processing. For example, an isolated area containing a dosage form to be taken in the morning may be yellow, while a separate area containing a dosage form to be taken in the afternoon may be orange. There is no limit. In addition, the formulation form may also be directly color coded. For example, each formulation formulation form to be administered in the morning can be identified by red color, and the formulation formulation form to be administered at night can be identified by blue color, without limitation. In addition, each individual recess may be color coded individually for visual marking. Since each recess can be made of a permeable or semipermeable material, color code treatment for the formulation form unit can be seen while the formulation form unit is housed in the recess. For example, each recess for an AM dose can be green and easily visible while in the blister pack. Optionally, this recess can be of opaque color. Color annotations may be provided in the blister pack to indicate the color corresponding to the date or time of taking. This marker provides a reliable and effective feedback system because the marker on the blister pack can be compared with a calendar or clock so that the patient can determine whether the proper formulation is taken at the right time on the right date. The patient can easily determine whether the dose is wrong, or whether more than one dose has been taken at the wrong time and has been detrimental.
[87] The dosage form unit of the subject matter of the present invention may consist of any bioactive material, but there is no limitation thereto. Preferably, the formulation unit of the present invention is vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, vitamin K, essential fatty acids, folic acid, iron, calcium, magnesium, potassium, copper, chromium, Zinc, molybdenum, iodine, boron, selenium, manganese, derivatives thereof or combinations thereof. Unlimited examples of bioactive materials of the present subject matter include diamines, diamine pyrophosphates, riboflavin, flavin mononucleotides, flavin adenine, dinucleotides, niacin, nicotinic acid, nicotinamide, niacinamide, Nicotinamide adenine dinucleotide, tryptophan, biotin, pantothenic acid, ascorbic acid, retinol, retinal, retinoic acid, beta-carotene, 1,25-dihydroxycholecalciferol, 7 Dehydrocholesterol, alpha-tocopherol, tocopherol, tocotrienol, menadione, menaquinone, piloquinone, naphthoquinone, calcium, calcium carbonate, calcium sulfate, calcium oxide, calcium hydroxide, calcium apatite, calcium sheet Calcium citrate-malate, calcium gluconate, calcium lactate, calcium phosphate, calcium levulinate, phosphorus, potassium, sulfur, sodium, docusate sodium, salt Cargoes, magnesium, magnesium stearate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium sulfate, copper, iodine, zinc, chromium, molybdenum, carbonyl iron, ferrous fumarate, polysaccharide iron, and Combinations and derivatives thereof may be included, without limitation. Unlimited examples of vitamin compounds include salts, alkaline salts, esters and chelates of certain vitamin compounds.
[88] The dosage form unit may be a prescription substance or a nonprescription substance, but there is no limitation thereto. Prescription substances include hormone replacement agents, contraceptive agents, osteoporosis agents, analgesics, steroids, appetite reducing agents, weight loss agents, smoking cessation agents, cholesterol reducing agents, and combinations thereof.
[89] Unlimited examples of prescription substances include erythromycin, penicillin, cephalosporin, theophylline, albuterol, terbutalin, diltiazem, propranolol, nifedepine, clonidine, thiolidazine, diazepam, meclizin , Ergoroid, mesylate, chlorpromazine, carbidopa, levodopa, beclomethasone, diproprionate, budesonide, dexamethasone, flunisolid, fluticasone proprionate, mometasone furoart , Triamcinolone, acetoid, beconase, pulmikort, linocourt, tecadron, erovide / nasolide, florvent / flonase, azmacort, amprenavir, adefovir difficile, leadership Tin, Azidothymidine, AZT, Paclitaxel, Cyclophosphamide, Teniposide, Taxol, Cytosan, Bumon, Methotrexite, Cisplatin, Carboplatin, Oxaliplatin, Platinol, Paraplatin, Adriamycin , Ble Omicin, dactinomycin, daunorubicin, doxorubicin, indarubicin, mitomycin, blenoic acid, cosmegen, cerubidine, rubix, indamycin, mutacin, BCNU, streptozosin, vinblastine, Thiodepa, conjugate estradiol, ethynyl estradiol, methoxyprogesterone, meprobamate, desogestrel, levonorestrel, noretindron, norretindrode acetate, norchestimate, norchestrel, raloxyphene, tamoxifen , Methyltestosterone, quinapril, losartan, sotarol, arendronate, atorvastatin, cholestipol, clofibrate, and combinations thereof.
[90] Unlimited substances included in the first or second dosage form are vitamins or derivatives thereof, or mineral compounds or derivatives thereof. Vitamil or mineral compounds include thiamine, thiamine pyrophosphate, riboflavin, flavin mononucleotides, flavin adenine dinucleotides, niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide adenine dinucleotides, tryptophan, biotin, folic acid , Pantothenic acid, ascorbic acid, retinol, retinal, retinoic acid, beta-carotene, 1,25-dihydroxycholecalciferol, 7-dehydrocholesterol, alpha-tocopherol, tocopherol, tocotrienol, Menadione, Menaquinone, Philoquinone, Naphthoquinone, Calcium, Calcium Carbonate, Calcium Sulfate, Calcium Oxide, Calcium Hydroxide, Calcium Apatite, Calcium Citrate-malate, Calcium Gluconate , Calcium acetate, calcium phosphate, calcium levulinate, phosphorus, potassium, sulfur, sodium, docusate sodium, chloride, magnesium, magnesium stearate, carbon Magnesium acid, magnesium oxide, magnesium hydroxide, magnesium sulfate, copper, iodine, zinc, chromium, molybdenum, carbonyl iron, ferrous fumarate, polysaccharide iron, and combinations and derivatives thereof There is no limit to this. Unlimited examples of vitamin compounds include, but are not limited to, salts, alkaline salts, esters and chelates of certain vitamin compounds. In addition, nonprescription materials include, but are not limited to, vegetable compounds, vegetable extracts, derivatives thereof, or combinations thereof.
[91] The first dosage form unit is aligned adjacent to the second dosage form unit in a blister pack. The first and second dosage form units occupy different recesses in the same discrete area. The first and second dosage form units each take an independent oral dosage form. Oral dosage forms are chewable tablets, rapid dissolving tablets, effervescent tablets, enteric skin tablets, hard gelatin capsules, soft gelatin capsules, reconstituted powders, suspensions, elixirs, tablets, caplets, liquid forms And combinations thereof. More preferably, when either one of the first and second dosage form units is a tablet, the other dosage form unit is a soft gelatin capsule. While this soft gelatin capsule may contain a material that is ideally suited for administration in the form of a soft gelatin capsule, the tablet is ideally administered simultaneously with the material of the soft gelatin capsule but is incompatible with the form of the soft gelatin preparation formulation. And, for example, vitamin C, but there is no limitation thereto.
[92] Storage incompatible substances may result in a single formulation formulation unit that is too large to swallow, or that the total amount of any substance or formulation formulation that cannot be formulated together in a single formulation formulation unit or that cannot be stored together in direct contact because of negative interactions. And may not be formulated together in a single dosage unit. In addition, storage incompatible materials include various materials that can be stored in direct contact, but it is preferred that one of these materials be formulated in the form of a formulation that is incompatible or incompatible with the rest of the material. This storage incompatible material may include any storage incompatible material, but there is no limitation thereto.
[93] For example, storage incompatible materials include hydrophobic and hydrophilic compounds, olefin compounds and non-olefin compounds, pH sensitive compounds and pH insensitive compounds, materials requiring anhydrous environments and materials requiring non-anhydrous environments, Acidic drugs, basic drugs, effervescent tablets and highly functional drug or pharmaceutical formulation forms, gelatin capsules and aldehydes, quaternary ammonium compounds, nonionic materials or combinations thereof.
[94] Unlimited examples of storage incompatible materials include ascorbic acid and aluminum hydroxide, ascorbic acid and sodium bicarbonate, citric acid and sodium carbonate, folic acid and calcium carbonate, activated charcoal and amyl nitrate, gelatin capsules and formaldehyde, Gelatin capsules and gluteraldehyde, kosinin chloride and soap, ethylpyridinium chloride and sodium stearate and combinations thereof.
[95] The separated regions are arranged in a structure such that the first and second dosage form units can be easily separated together and administered together. Simultaneous administration can easily be made in a wide variety of ways. For example, simultaneous administration may be achieved by the intimate approach of the first and second dosage form units in a blister pack, by the use of two dosage form units at the same time, by the marking that both of them may be administered simultaneously. By means of a safety seal, it is easily possible by means of simultaneously releasing or forcing the dosage form unit out of the blister pack, or by a combination thereof, without limitation.
[96] Each separated region is visually represented by at least one line forming an adjacent separated region. This line can be perforated. Where the blister pack has one or more discrete regions, the one or more discrete regions are suitable for storage if the at least one discrete region in the blister pack contains storage incompatibilities in the respective recesses. It may include a substance.
[97] The apparatus also has a container for receiving and storing a blister pack. This vessel is divided into a plurality of individual compartments. At least one compartment is for accommodating and storing a blister pack, and at least one compartment is for accommodating and storing a loose or unpacked double-bath form. The apparatus of the present invention may be composed of a sheet molded body, a rolled molded body, a multi-dimensional molded body, or other molded body.
[98] The devices and methods of the present invention may incorporate non-uniform or unequal administration over a whole day or period of 24 hours. For example, a blister pack may provide certain amounts of certain vitamins for morning administration and different amounts of the same vitamin for afternoon administration. In addition, the kinds of morning and afternoon materials need not be identical. The use of the substance may alternatively be in the form of a dosage form, for example, once every other time, without limitation, the formulation of a particular vitamin may be the same, or may be in a single dosage form every other time, That is, the presence or absence of certain vitamins alternates. The use of the substance is gradual, without limitation, for example, the amount of certain compounds may be administered in increasing amounts throughout the course of the regimen.
[99] The methods and devices of the present subject matter can be used by any human or other animal. The methods and apparatus of the present invention may be particularly suitable individually in the case of special treatment needs or specific treatment needs, especially where such needs benefit from complex treatment regimens. For example, the device and method are particularly suitable for menopausal women, women giving birth, pregnant women, men and women considering pregnancy of their children, individuals suffering from pathological conditions, or in combination with those situations. There is no restriction on this.
[100] Subjects of the present invention include methods of supporting optimal treatment for animals by increasing the adaptability to the combined dosing regimen to facilitate simultaneous administration of storage incompatible substances. In addition, the subject matter includes methods of increasing the patient's adaptability to prescription therapeutic substances. The method consists of firstly providing a blister pack having at least one row of a plurality of discrete regions. Preferably, each separated region has an independently accessible, detachable or breakable seal. Each heat likewise has an independently accessible, detachable or breakable seal. The method includes providing a first dosage form unit containing a non-prescription substance in a recess of one separate region. This nonprescription substance may be a therapeutic agent. Therapeutic agents include thiamine, thiamine pyrophosphate, riboflavin, flavin mononucleotide, flavin adenine dinucleotide, niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide adenine dinucleotide, tryptophan, biotin, pantothenic acid, ascorbic acid, Retinol, retinal, retinoic acid, beta-carotene, 1,25-dihydroxycholecalciferol, 7-dehydrocholesterol, alpha-tocopherol, tocopherol, tocotrienol, menadione, menaquinone, phyllo Quinones, naphthoquinones, calcium, calcium carbonate, calcium sulfate, calcium oxide, calcium hydroxide, calcium apatite, calcium citrate-malate, calcium gluconate, calcium nitrate, calcium phosphate, Calcium levulinate, phosphorus, potassium, sulfur, sodium, docusate sodium, chloride, magnesium, magnesium stearate, magnesium carbonate, magnesium acid Cargo, Magnesium Hydroxide, Magnesium Sulfate, Copper, Iodine, Zinc, Chromium, Molybdenum, Carbonyl Iron, Ferrous Fumarate, Polysaccharide Iron, Linolenic Acid, Linoleic Acid, Docosahexanoic Acid, Archidonic acid and combinations and derivatives thereof, including, but not limited to.
[101] The method also provides a second dosage form unit containing a prescription therapeutic substance in the recess of the blister pack such that the second dosage form unit is disposed adjacent to the first dosage form unit. This prescription substance includes hormone replacement agents, contraceptives, osteoporosis agents, chemotherapeutic agents, anti-infective agents, analgesics, steroids, appetite reducers, weight loss agents, smoking cessation agents, cholesterol reducing agents, and combinations thereof. This prescription therapeutic substance may be an ingredient that may be a nonprescription drug or a drug available by prescription when the dosage form is small, but there is no limitation thereto.
[102] The method also includes providing a mark on the blister pack corresponding to the first and second dosage form units. In addition, this marker provides a reliable and effective feedback system, by comparing the marker on the blister pack with a calendar or clock, allowing the patient to determine whether the correct formulation was taken at the right time on the right date. to be. The patient can easily determine whether the dose is wrong, or whether more than one dose has been taken at the wrong time and has been detrimental.
[103] The method of the present invention comprises administering to the animal a storage non-conformant of the blister pack and / or a prescription and non-prescription therapeutic substance together at the time indicated by the marker. The method of the present invention includes a treatment plan. This treatment plan is preferably a routine treatment plan. More preferably, this treatment plan is a complex routine treatment plan.
[104] One or more blister packs within the above-described configuration may be embedded in a suitable dispense box with printed materials and / or hearing / visual aids to support the adaptation state thereto.
[105] The method of the present subject matter is not strictly limited to blister packs. Any conventional medication container (s) similar in structure to the blistuck pack may be suitable. Unlimited examples of such containers include bottles, vials, tubes, canisters, envelopes, and the like.
[106] Therefore, since the present invention has been described, it will be apparent that the present invention can be variously modified. Such modifications are to be considered as not departing from the spirit and scope of the invention, and all such modifications are intended to be within the scope of the appended claims.
权利要求:
Claims (85)
[1" claim-type="Currently amended] In a disposable dispensing device that increases the adaptability to a complex dosing regimen and supports optimal treatment for animals by facilitating simultaneous administration of storage-incompatible materials,
A blister pack having two or more separate regions each having at least a first recess and a second recess formed therein;
A first pharmaceutical formulation unit occupying said first recess and comprising a first bioactive material,
A second pharmaceutical formulation unit occupying said second recess and comprising a second bioactive material,
The complex dosage regimen requires simultaneous administration of the first and second bioactive materials, the first bioactive materials being storage-incompatible with the second bioactive materials,
The first and second recesses independently block intimate access of the first and second dosage form units to prevent interaction between the first and second bioactive materials to provide storage stability. Disposable device for dispensing, while promoting the simultaneous administration of the active substance.
[2" claim-type="Currently amended] The complex dosing plan of claim 1, further comprising an expiration date mark provided on the blister pack, wherein the expiration date mark indicates on which date the dosage form unit should be administered corresponding to each of the separated regions. Disposable dispensing device to increase the patient's adaptability to.
[3" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein each separate region comprises a seal that is independently accessible, detachable, or breakable.
[4" claim-type="Currently amended] 4. The disposable dispensing device of claim 3 wherein said sealing means is a safety seal.
[5" claim-type="Currently amended] 4. The disposable dispensing device of claim 3 wherein the sealing means is a pull-tab.
[6" claim-type="Currently amended] 6. The disposable dispensing device of claim 5 wherein the pull-tab has a visual marker.
[7" claim-type="Currently amended] 2. The disposable dispensing apparatus of claim 1, further comprising a time marker in the blister pack for displaying a general time for a date corresponding to each of the separated areas.
[8" claim-type="Currently amended] 8. The disposable dispensing device of claim 7, wherein said visual marker is color coded.
[9" claim-type="Currently amended] 8. The disposable dispensing device of claim 7, wherein the general time of day is selected from the group consisting of AM, PM, morning, afternoon, evening, day, night, day, night and combinations thereof.
[10" claim-type="Currently amended] 2. The method of claim 1, wherein the time displayed at the first row position of the plurality of separated regions is aligned with an AM, and the time displayed at the second row position of the plurality of separated regions is aligned with a PMM. Disposable Dispenser.
[11" claim-type="Currently amended] 11. The method of claim 10, wherein the first dosage form unit of each separated region in the first row and the second dosage form unit of each separated region in the second row are of different kinds or non-uniform amounts of bioactive material. Disposable dispensing device containing a.
[12" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein each separate region is visually represented by at least one line forming an adjacent region.
[13" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein each separate region is formed by at least one perforation line delimiting the region from an adjacent region.
[14" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the blister pack includes one or more rows of the plurality of discrete regions.
[15" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the first recess contains a soft gelatin capsule and the second recess contains a tablet.
[16" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the first bioactive material is a hydrophobic compound and the second bioactive material is a hydrophilic compound.
[17" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the first bioactive material is an olefin compound and the second bioactive material is a non-olefin compound.
[18" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the first bioactive material is a pH sensitive compound and the second bioactive material is a pH insensitive compound.
[19" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the first bioactive material requires an anhydrous environment and the second bioactive material requires a non-anhydrous environment.
[20" claim-type="Currently amended] The method of claim 1, wherein the first and second bioactive substances are vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, vitamin V, essential fatty acids, folic acid, iron, calcium, magnesium, Disposable dispensing device independently selected from the group consisting of potassium, copper, chromium, zinc, molybdenum, iodine, boron, selenium, manganese, derivatives thereof or combinations thereof.
[21" claim-type="Currently amended] The method of claim 1, wherein the first and second bioactive materials are thiamine, thiamine pyrophosphate, riboflavin, flavin mononucleotide, flavin adenine dinucleotide, niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide adenine Dinucleotide, tryptophan, biotin, pantothenic acid, ascorbic acid, retinol, retinal, retinoic acid, beta-carotene, 1,25-dihydroxycholecalciferol, 7-dehydro Cholesterol, Alpha-Tocopherol, Tocopherol, Tocotrienol, Menadione, Menaquinone, Philoquinone, Naphthoquinone, Calcium, Calcium Carbonate, Calcium Sulfate, Calcium Oxide, Calcium Hydroxide, Calcium Apatite, Calcium Citrate-Mal Calcium citrate-malate, calcium gluconate, calcium lactate, calcium phosphate, calcium levulinate, phosphorus, potassium, sulfur, sodium, docusate sodium, chloride, magnesium, Magnesium Tearate, Magnesium Carbonate, Magnesium Oxide, Magnesium Hydroxide, Magnesium Sulfate, Copper, Iodine, Zinc, Chromium, Molybdenum, Carbonyl Iron, Ferrous Fumarate, Polysaccharide Iron, Linolenic Acid, Linoleic Acid, Docosa Disposable dispensing device is selected independently from the group consisting of hexanoic acid, archidonic acid and combinations and derivatives thereof.
[22" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the first and second bioactive materials are independently vitamin compounds or derivatives thereof.
[23" claim-type="Currently amended] The method of claim 1, wherein the first formulation unit and the second formulation unit is a dosage form, oral, buccal, sublingual, rectal, parenteral, applied, inhaled, injectable and Disposable dispensing device independently selected from the group consisting of transdermal.
[24" claim-type="Currently amended] The formulation of claim 23, wherein the oral formulation is a chewable tablet, a quick dissolving tablet, a foamable tablet, a hard gelatin capsule, a soft gelatin capsule, a reconstituted powder, a suspension, an elixir, a tablet, a caplet Disposable device, which is selected from the group consisting of (caplet), and combinations thereof.
[25" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the date mark is color coded.
[26" claim-type="Currently amended] The disposable dispensing device of claim 1 further comprising a container for receiving and storing the blister pack.
[27" claim-type="Currently amended] 27. The container of claim 26, wherein the container is divided into a plurality of individual compartments, at least one of the compartments is for receiving and storing the blister pack, and at least one of the compartments is adapted for loose or unpackaged formulations. Disposable dispensing device for use in storage and storage.
[28" claim-type="Currently amended] The disposable dispensing apparatus of claim 1, wherein the blister pack includes one or more rows of the plurality of discrete regions.
[29" claim-type="Currently amended] The disposable dispensing device according to claim 1, wherein the dispensing device is composed of a rolled molded body.
[30" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the first and second dosage form units are marked with a date label and the top of the recess consists of a permeable material.
[31" claim-type="Currently amended] The disposable dispensing device of claim 1 wherein the first and second dosage form units are marked with visual markers and the top of the recess is comprised of a permeable material.
[32" claim-type="Currently amended] The disposable dispensing device of claim 1 further comprising a treatment device.
[33" claim-type="Currently amended] The disposable dispensing device of claim 1, wherein the treatment device is for reducing or eliminating nausea,
[34" claim-type="Currently amended] A storage stable disposable dispensing device which increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance,
A storage stability blister pack having at least one row of a plurality of discrete regions each of which at least one recess is formed,
A first pharmaceutical formulation unit occupying at least one recess formed in said at least one discrete region and being a non-prescription substance;
A second formulation formulation unit occupying at least one recess of said at least one discrete region, said formulation being a prescription substance and arranged in said blister pack adjacent said first formulation formulation unit,
A date mark provided to the blister pack corresponding to the at least one separated region;
And wherein each of the separated regions is provided with a seal that is independently accessible, detachable or breakable.
[35" claim-type="Currently amended] 35. The storage stability disposable device of claim 34, further comprising a time mark provided in the blister pack and displaying a general time for the date corresponding to each of the separated regions.
[36" claim-type="Currently amended] 35. The storage stability disposable device of claim 34, wherein said visual marker is color coded.
[37" claim-type="Currently amended] 35. The storage stability disposable dose device of claim 34, wherein the general time of day is selected from the group consisting of AM, PM, morning, afternoon, evening, day, night, day, night and combinations thereof.
[38" claim-type="Currently amended] 35. The storage stability disposable dispensing device of claim 34, wherein said first and second dosage form units occupy the same area.
[39" claim-type="Currently amended] 35. The storage stability disposable dispensing device of claim 34 wherein each separated region is visually represented by at least one line forming an adjacent region.
[40" claim-type="Currently amended] 35. The storage stability disposable device of claim 34, wherein each separate region is formed by at least one perforation line delimiting the region adjacent to the region.
[41" claim-type="Currently amended] 35. The storage stability disposable device of claim 34, wherein the blister pack comprises one or more rows of the plurality of discrete regions.
[42" claim-type="Currently amended] 35. The storage stable disposable device of claim 34, wherein the non-prescription substance is a therapeutic agent.
[43" claim-type="Currently amended] 35. The storage stable disposable dispensing device of claim 34, further comprising a third dosage form unit containing a second non-prescription substance.
[44" claim-type="Currently amended] 35. The storage stable disposable dispensing device of claim 34, further comprising a third dosage form unit containing a second prescription therapeutic substance.
[45" claim-type="Currently amended] 35. The storage stable disposable device of claim 34, wherein the non-prescription substance is a vitamin compound or derivative thereof.
[46" claim-type="Currently amended] 35. The storage stable disposable device of claim 34, wherein the non-prescription material is an acceptable mineral compound or derivative thereof.
[47" claim-type="Currently amended] 35. The storage stable disposable device of claim 34, wherein the non-prescription substance is a vegetable compound or a derivative thereof.
[48" claim-type="Currently amended] 35. The method of claim 34, wherein the first and second dosage forms are oral, buccal, sublingual, rectal, parenteral, applied, inhaled, injectable and A storage stability disposable dispensing device selected from the group consisting of transdermal forms.
[49" claim-type="Currently amended] 49. The oral formulation of claim 48, wherein the oral formulation is a chewable tablet, a quick dissolving tablet, a foamable tablet, a hard gelatin capsule, a soft gelatin capsule, a reconstituted powder, a suspension, an elixir, a tablet, a caplet. A storage stability disposable dispensing device selected from the group consisting of a caplet, and combinations thereof.
[50" claim-type="Currently amended] 35. The storage stability disposable device of claim 34, wherein the date mark is color coded.
[51" claim-type="Currently amended] 35. The storage stability disposable dispensing device of claim 34, further comprising a container for containing and storing the blister pack.
[52" claim-type="Currently amended] 53. The container of claim 51, wherein the container is divided into a plurality of individual compartments, at least one of the compartments is for receiving and storing the blister pack, and at least one of the compartments is adapted for loose or unpacked formulations. Storage stability disposable dispensing device for use in storage and storage.
[53" claim-type="Currently amended] 35. The storage stability disposable device of claim 34, wherein the blister pack has one or more rows of the plurality of discrete regions.
[54" claim-type="Currently amended] 35. The storage stability disposable device according to claim 34, wherein the dispensing device is composed of a rolled molded body.
[55" claim-type="Currently amended] 35. The storage stability disposable dispensing device of claim 34, wherein said first and second dosage form units comprise a date mark and the top of said recess consists of a permeable material.
[56" claim-type="Currently amended] A storage stable disposable dispensing device which increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance,
A storage stable blister pack having at least one row of a plurality of discrete regions each of which at least one recess is formed,
A first pharmaceutical formulation unit occupying at least one recess formed in said at least one discrete region and containing a non-prescription substance;
A second formulation formulation unit occupying at least one recess formed in said at least one separate region, containing a prescription substance and arranged in said blister pack adjacent to said first formulation formulation unit,
A date mark provided to the blister pack corresponding to the at least one separated region;
And wherein the rows of the plurality of discrete zones have seals that are independently accessible, detachable or breakable seals.
[57" claim-type="Currently amended] 57. The storage stability disposable device of Claim 56, wherein the dispensing device is comprised of a rolled molded body.
[58" claim-type="Currently amended] 58. The container of claim 57, wherein the container is divided into a plurality of individual compartments, at least one of the compartments is for receiving and storing the blister pack, and at least one of the compartments is adapted for loose or unpacked formulations. Storage stability disposable dispensing device for use in storage and storage.
[59" claim-type="Currently amended] A storage stable disposable dispensing device which increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance,
A storage stable blister pack having at least one row of a plurality of discrete regions each of which at least two recesses are formed,
A first preparation formulation unit occupying a first recess of the first separation region and containing a non-prescription substance;
A second formulation formulation unit occupying a second recess of the first separation region, containing a prescription substance, and arranged in the blister pack adjacent to the first formulation formulation unit;
A date mark provided to the blister pack corresponding to at least one of the separated regions;
And wherein each of the separated regions is provided with a seal that is independently accessible, detachable or breakable.
[60" claim-type="Currently amended] 60. The storage stability disposable device of claim 59, wherein the dispensing device is comprised of a rolled molded body.
[61" claim-type="Currently amended] 60. The storage stability disposable dispensing device of claim 59, further comprising a container for containing and storing the blister pack.
[62" claim-type="Currently amended] 62. The container of claim 61, wherein the container is divided into a plurality of individual compartments, at least one of the compartments is for receiving and storing the blister pack, and at least one of the compartments is adapted for loose or unpackaged formulations. Storage stability disposable dispensing device for use in storage and storage.
[63" claim-type="Currently amended] 60. The storage stability disposable dispensing device of claim 59, wherein the first and second dosage form units comprise a date mark and the top of the recess consists of a permeable material.
[64" claim-type="Currently amended] A storage stability disposable dispensing device which increases patient's adaptability to daily treatment plans through proximity and joint access to multiple therapeutic ingredients to be administered simultaneously,
A blister pack having at least one row of a plurality of discrete regions each having two recesses,
A first dosage form unit occupying a first recess of the first separation region and containing a first therapeutic substance,
A second preparation formulation unit occupying a second recess of the first separation region and containing a second prescription substance;
The second formulation formulation unit arranged in the blister pack adjacent to the first formulation formulation unit,
A date mark provided to the blister pack corresponding to at least one of the separated regions;
And wherein each of the separated regions is provided with a seal that is independently accessible, detachable or breakable.
[65" claim-type="Currently amended] A storage stable disposable dispensing device which increases patient's adaptability to taking at least one prescription substance through proximity and joint access to at least one non-prescription substance,
A blister pack having at least one row of a plurality of discrete regions in which at least one recess is formed,
Occupies at least one recess formed in the at least one separate region and reduces hormone replacement agents, contraceptives, osteoporosis agents, chemotherapy agents, anti-infective agents, analgesics, steroids, appetite reducers, weight loss agents, smoking cessation agents, cholesterol reduction A first dosage form unit containing a prescription substance selected from the group consisting of an agent and combinations thereof,
A second dosage form unit occupying at least one recess formed in said at least one separate region, containing a prescription therapeutic substance, and arranged in said blister pack adjacent to said first dosage form unit,
A date mark provided to the blister pack corresponding to at least one of the separated regions;
And wherein each of the separated regions is provided with a seal that is independently accessible, detachable or breakable.
[66" claim-type="Currently amended] 66. The method of claim 65, wherein the container is divided into a plurality of individual compartments, at least one of the compartments is for receiving and storing the blister pack, and at least one of the compartments is adapted for loose or unpacked formulations. Storage stability disposable dispensing device for use in storage and storage.
[67" claim-type="Currently amended] In a disposable dispensing device that supports the optimal treatment for animals by increasing the adaptability to the combined dosing regimen to facilitate the administration of heterogeneous doses of bioactive substances,
A blister pack having at least two rows of a plurality of separate regions,
A first recess in each of the separated regions, each recess having a first formulation formulation unit formed therein, the first row of the separated regions having a first visual marker,
A first recess each formed in each of the separated regions adapted to receive a second dosage unit, comprising a second row of separated regions having a second visual marker,
And wherein said first dosage form unit has an amount greater or less than said second dosage form unit by weight of a bioactive agent.
[68" claim-type="Currently amended] 69. The blister pack of claim 67, wherein the blister pack further includes a date marker, wherein the date marker corresponds to each of the separated regions to indicate on which date the dosage form unit should be administered. Storage stability disposable dispensing device to increase the patient's adaptability to.
[69" claim-type="Currently amended] 69. The method of claim 68, wherein the date mark is Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 23, 24, 25, 26, 27, 28, 29, 30, 31, one, two, three, four, five, six, Seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty, twenty-one, twenty-one, twenty-two, twenty-three, twenty-four, twenty-five, twenty-four Six, twenty-seven, twenty-eight, twenty-nine, thirty, thirty-one, January, February, March, April, May, June, July, August, September, October, November, 12 Storage stability disposable dispensing device which is a wall and combinations thereof.
[70" claim-type="Currently amended] A disposable dispensing device that supports optimal treatment for animals by increasing the adaptability to a complex dosing regimen to facilitate the administration of heterogeneous doses of bioactive materials,
A blister pack having at least two rows of a plurality of separate regions,
A first recess in each of the separated regions, each recess being adapted to receive a first formulation unit, a first row of the separated regions having a first visual marker,
The separated regions each having a first recess formed to receive a second formulation unit, each comprising a second row of the separated regions having a second visual marker,
The first formulation dosage unit has a larger volume than the second formulation, a smaller volume than the second formulation, or is different in shape from the second formulation. Device.
[71" claim-type="Currently amended] 71. The blister pack of claim 70, wherein the blister pack further includes a date marker, wherein the date marker corresponds to each of the separated regions to indicate on which date the pharmaceutical formulation unit should be administered. Storage stability disposable dispensing device to increase the patient's adaptability to.
[72" claim-type="Currently amended] 72. The method of claim 71 wherein the date mark is Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 23, 24, 25, 26, 27, 28, 29, 30, 31, one, two, three, four, five, six, Seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty, twenty-one, twenty-one, twenty-two, twenty-three, twenty-four, twenty-five, twenty-four Six, twenty-seven, twenty-eight, twenty-nine, thirty, thirty-one, January, February, March, April, May, June, July, August, September, October, November, 12 Storage stability disposable dispensing device which is a wall and combinations thereof.
[73" claim-type="Currently amended] A method of supporting optimal treatment for animals by increasing the adaptability to a complex dosing regimen to facilitate concurrent administration of storage-incompatible materials,
Providing a blister pack having a plurality of discrete regions forming at least a first and a second recess,
Providing a second dosage form unit occupying said first recess and consisting of a first bioactive material;
Providing a second dosage form unit occupying said second recess and consisting of a second bioactive material;
Providing a date marker on the blister pack to increase the patient's adaptability to the complex dosing schedule by indicating on which date the dosage form unit should be administered corresponding to each of the separated regions;
Administering the non-prescription therapeutic substance and the prescription therapeutic substance of the blister pack together to the animal when indicated by the date label,
The complex dosage regimen requires simultaneous administration of the first and second bioactive materials, the first bioactive material being storage-incompatible with the second bioactive material,
The first recess and the second recess independently block intimate access to the first formulation unit and the second formulation unit to prevent interaction between the first and second bioactive materials while Providing storage stability by facilitating simultaneous administration of the substance.
[74" claim-type="Currently amended] 74. The method of claim 73, wherein said animal is a pregnant female.
[75" claim-type="Currently amended] The method of claim 73, wherein the animal is a female giving birth.
[76" claim-type="Currently amended] 74. The method of claim 73, wherein said animal is a menopausal female.
[77" claim-type="Currently amended] The method of claim 73, wherein the animal is a male or pregnant female preparing to conceive a child.
[78" claim-type="Currently amended] In a method of increasing the patient's adaptability to a prescription therapeutic substance,
Providing a blister pack having at least one row of a plurality of distanced regions,
Providing a first pharmaceutical formulation unit containing a non-prescription substance in the recess of the one separate region,
Providing a second dosage form unit containing a prescription therapeutic substance in the recess of the blister pack, such that the second dosage form unit is disposed adjacent to the first dosage form unit,
Marking the blister pack in correspondence to the first and second dosage form units;
Administering the prescription therapeutic substance and the non-prescription substance of the blister pack together to the animal at the time indicated by the marker.
[79" claim-type="Currently amended] 79. The method of claim 78, wherein said separated region has sealing means that can be independently accessed, separated, or destroyed.
[80" claim-type="Currently amended] 79. The method of claim 78, wherein the rows of the plurality of discrete regions have sealing means that can be independently accessed, separated, or disrupted.
[81" claim-type="Currently amended] 79. The method of claim 78, wherein the non-prescription substance is a nutrient.
[82" claim-type="Currently amended] In the method of increasing patient adaptability to the daily treatment plan,
Providing a blister pack having at least one row of a plurality of discrete regions,
Providing a first dosage form unit containing a prescription substance in the recess of the one separate region;
Providing a second dosage form unit containing a non-prescription therapeutic substance in the recess of the blister pack, such that the second dosage form unit is disposed adjacent to the first dosage form unit,
Marking the blister pack in correspondence to the first and second dosage form units;
And administering the nonprescription therapeutic substance of the blister pack and the prescription substance together to the animal at the time indicated by the marker.
[83" claim-type="Currently amended] 83. The method of claim 82, wherein the routine treatment plan is a complex routine treatment plan.
[84" claim-type="Currently amended] A method of supporting optimal treatment for an animal by increasing adaptability to a complex dosing regimen to facilitate the administration of a heterogeneous dose of at least one bioactive substance,
Providing a bioactive material to a blister pack having a first row of a plurality of separate regions and a second row of the plurality of discrete regions, each of the separated regions of the first row comprising a first formulation formulation unit A recess for accommodating the second column, wherein each of the separated regions of the second row receives a second formulation unit;
The separated region of the first column corresponds to a first visual marker, the separated region of the second column corresponds to a second visual marker,
Providing a second row of separate regions having a second visual marker, each of the separated regions respectively forming a first recess adapted to receive a second formulation unit,
Wherein said first and second dosage form units contain said heterogeneous amount of bioactive material.
[85" claim-type="Currently amended] 85. The method of claim 84, wherein the blister pack has a date marker corresponding to each discrete area to increase patient adaptability to the complex dosing schedule by indicating on which day the dosage unit should be administered. How to be.
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同族专利:
公开号 | 公开日
EP1207850B1|2008-10-22|
CA2378378A1|2001-02-21|
EP1207850A1|2002-05-29|
WO2001007012A1|2001-02-01|
ES2182729T1|2003-03-16|
DE1207850T1|2003-01-09|
AT411794T|2008-11-15|
US6375956B1|2002-04-23|
JP2003505154A|2003-02-12|
ES2182729T3|2009-03-16|
BR0013173A|2002-04-02|
DE60040605D1|2008-12-04|
AU5780100A|2001-02-13|
AU780297B2|2005-03-17|
EP1207850A4|2006-03-22|
MXPA02000806A|2002-07-22|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题
法律状态:
1999-07-22|Priority to US09/358,540
1999-07-22|Priority to US09/358,540
2000-06-30|Application filed by 프란시스 비이. 자콥, 드러그테크 코포레이션
2000-06-30|Priority to PCT/US2000/017959
2002-05-23|Publication of KR20020038698A
优先权:
申请号 | 申请日 | 专利标题
US09/358,540|US6375956B1|1999-07-22|1999-07-22|Strip pack|
US09/358,540|1999-07-22|
PCT/US2000/017959|WO2001007012A1|1999-07-22|2000-06-30|Strip pack|
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