巴西专利BR112013025395B1 Blister packaging and manufacturing method of a bubble wrap

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BLISTER PACKAGE FOR PHARMACEUTICAL CARTRIDGES This is a blister pack for a pharmaceutical cartridge or capsule.
公开号:BR112013025395B1
申请号:R112013025395-9
申请日:2012-03-30
公开日:2022-02-01
发明作者:Michael S. Bergey
申请人:Mannkind Corporation；
IPC主号:

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Cross-Reference with Related Orders
[001] This invention claims the benefit of US Provisional Patent Application No. 61/470,982, filed April 1, 2011, the disclosure of which is fully incorporated herein by reference. Field of Invention
[002] This invention relates to a blister pack for an injection molded pharmaceutical cartridge or capsule. Fundamentals of Invention
[003] Blister packaging systems can be used to protect medicinal products in the pharmaceutical industry such as capsules, tablets, powders and liquids. Generally, blister packs consist of a blister base plate that has open cavities or blisters and a cover plate or lid. Each blister in a package usually contains the medicinal product in the form of a powder, capsule or tablet.
[004] A medicament delivery system for inhalation may include a cartridge for delivering a dry powder formula to the pulmonary tract and lungs for the treatment of disease. The medicated formulas contained in the cartridge can be used with a dry powder inaction system, which delivers the medication contents in a safe and consistent manner. Medicinal formulas used for pulmonary inhalation with a cartridge delivery system, however, may be sensitive to degradation, for example, from exposure to moisture. In this way, a cartridge containing the powdered formula can benefit from an improved packaging design to protect the cartridge from physical damage and environmental factors. Summary of the Invention
[005] The present invention is directed to blister packs to protect cartridges containing pharmaceutical formula to be used with an inhaler. In one example, cartridges used with a dry powder inhalation system are described in US Patent Nos. D613849 and US Patent Application Serial Nos. 12/484,137 (US 2009/0308392). Blister packs can be designed to contain, protect, dispense and/or improve the stability of a pharmaceutical formula. In one embodiment, the formulas may be designed for pulmonary delivery for the treatment of diseases, including systemic and endocrine diseases such as diabetes. Blister packs can provide structural rigidity that resists leakage of used material and can also create a barrier to environmental factors such as moisture, light and/or dust; may facilitate the dispensing of a dose of medication to be administered to a patient. In one embodiment, blister packaging can provide a high moisture barrier to protect a cartridge comprising a drug formula during shipping, handling, and/or storage of the medicinal products prior to use.
[006] In one embodiment, blister packs comprise a plurality of blisters that are uniform bag-like holes, cup-like unit structures, and/or cavities arranged in rows or arrays; wherein each blister pack unit is configured to correspondingly match the structure of the pharmaceutical cartridge or capsule containing a pharmaceutical formula. In one embodiment, each bubble hole may house a corresponding cartridge. In another embodiment, blister packs may comprise one or more irregular blister holes or cavities, wherein each blister cavity or hole comprises a top, bottom, an outer surface, an inner surface, and a gap. The bottom may comprise an outer surface having a substantially rounded end or dome, and a substantially flat end or protrusion extending from the concave area. In one embodiment, the substantially flat end may have a notch or recess that forms a protrusion or cartridge-retaining appearance on the inner surface, and the gap area may be configured to house a cartridge comprising a cup-like container. In other embodiments, blister packs may comprise a plurality of single unit blister holes that are separated from one another by a spacer or segment of raw base material that is contiguous with an adjacent blister hole. In this embodiment, the blister pack may contain perforations or ribbed lines that surround each blister unit to separate the blister unit for ease of dispensing.
[007] In one embodiment, the blister packs comprise one or more blister holes per row and one or more rows per blister pack. In embodiments comprising two or more bubble holes in a row of bubbles, each bubble hole may be contiguous with another, and the internal volume or gap of each bubble hole may be in communication with all of the bubble holes. Alternatively, in some embodiments that have more than one bubble hole that are contiguous with each other, each bubble hole may be separated so that the volume and/or gap of each bubble hole cannot be in communication with a hole. bubble, any or all other adjacent bubble holes. In one embodiment, the blister packs may comprise one or more rows of blister holes, wherein each row of blisters may be separated by lines of perforation or fluted along the rows of blister holes or along lines that surround each unit of the blister pack.
[008] One embodiment comprises a blister comprising a base structure or material that has formed cavities comprised of a thermally deformable base laminate and a lid material including soft tempered aluminum foil with heat activated seal. The base material and/or structure may comprise one or more layers of a thermally deformable plastic, including a polyvinyl chloride, a polyester, and/or a fluoropolymer, for example, polychlorotrifluoroethylene (PCTFE) such as ACLAR. ® (Honeywell International Inc., NJ). In some aspects of the embodiments described herein, blister packs may comprise a base material comprising a laminated composite. In one embodiment, the laminated composite may comprise at least three selected layers of polyvinyl chloride and a fluoropolymer, such as an ACLAR layer and/or a material that has similar thermal deformation characteristics. In one embodiment, the laminated composite may comprise a three-layer film structure comprising a first layer of polyvinyl chloride, or polyethylene terephthalate (PET), a second layer of polyvinyl chloride, or PET, and a layer of a fluoropolymer including ACLAR, wherein the fluoropolymer layer comprises the intermediate layer of the laminated composite. In another embodiment, the blister baseboard may comprise a fluoropolymer such as a PET bonded PCTFE adhesive.
[009] In some embodiments, the laminated composite that forms the base material may be made to be of various thicknesses, and the thickness may depend on the degree of moisture barrier required for the formula. In one embodiment, the thickness of the laminated composite of the bubble baseboard can range from around 230 μm to around 720 μm. In another embodiment, the bubbled baseplate of the laminated composite can be approximately 360 µm to about 610 µm thick. In this embodiment, blister packs made with the base laminates result in blisters with adequate rigidity and moisture barrier protection with a thickness greater than 100 μm.
[010] In particular embodiments, blister packs may comprise one or more cavities and a cover or lid. Each cavity is configured to hold a cartridge which can be structured to fit a dry powder inhaler and the cartridge may include a formula for pulmonary delivery. The formula may comprise an active ingredient, including, but not limited to, a small molecule, peptide, nucleic acid molecule, or a combination thereof. In this and other embodiments, the cartridge may comprise a formula for treating, for example, diabetes, and the active ingredient in the formula may be selected from peptides, including, but not limited to, GLP-1 insulin, active fragments thereof, their analogues or combinations thereof. In other embodiments, the active ingredient may be selected from any peptide or agitating agent that can be delivered via the pulmonary route, including insulin, oxytocin, glucagon, parathyroid hormone, oxytomodulin, peptide YY, peptide type 1 glucagon, sumatriptan, inhibitor of peptidyl peptidase IV, parathyroid hormone, agonist and antagonist neurotransmitter, deoxyribonuclease I and active fragments thereof, analogues thereof and combinations thereof.
[011] Blister packs can be supplied for a single dosage, and/or multiple dosages, including daily dosage of a pharmaceutical formula, for two or more days, or a combination of several blisters can be provided for weekly or monthly as needed.
[012] In yet a further embodiment, blister packs may comprise a cartridge having a formula for treating a disease comprising an inhaled dry powder composition comprising a diketopiperazine. In one embodiment, the diketopiperazine may have a formula 3,6-bis-(4-X-aminobutyl)-2,5-diketo-diketopiperazine, wherein it is selected from the group consisting of succinyl, glutaryl, maleyl and fumaryl. In one embodiment, the dry powder composition may comprise a diketopiperazine salt; wherein the diketopiperazine salt may be an inorganic salt including sodium, potassium, magnesium, lithium, cesium and calcium. In one embodiment, the diketopiperazine can be an organic salt including triethylamine, butylamine, diethanolamine and triethanolamine. In yet another embodiment, dry powder compositions are provided wherein the diketopiperazine is 3,6-bis-(4- fumaryl-aminobutyl)-2,5-diketo-diketopiperazine or a salt thereof, with or without a pharmaceutically acceptable carrier. , or excipient. Blister packs may also comprise a cartridge with a formula with pharmaceutically acceptable carriers and/or excipients, but not limited to lactose, dextran, amino acids and the like. Brief Description of Drawings
[013] Figure 1 is a perspective view of a blister pack modality described herein.
[014] Figure 2 is a first side view of the blister pack in Figure 1 which describes a uniform arrangement of the rows of blisters inside the pack.
[015] Figure 3 is a second side view of the blister packing modality in Figure 1, which illustrates the rows of blisters from the opposite side of Figure 2.
[016] Figure 4 is a bottom view of the bubble packaging modality in Figure 1, which illustrates the organization of bubbles inside the package.
[017] Figure 5 is a top view of the blister packaging modality in Figure 1, which illustrates the lid.
[018] Figure 6 is a front view of the blister packaging modality in Figure 1, illustrating a row of three blisters and their configuration that describes a concave area and its notches or cartridge retention aspects.
[019] Figure 7 is a rear view of the blister packing modality in Figure 1.
[020] Figure 8 is a cross section of a row of bubbles through plane 8 to 8 as illustrated in Figure 1.
[021] Figure 9 is a longitudinal section of the blister pack through plane 9 to 9 crossing the center point of the bubble holes.
[022] Figure 10 illustrates a top view of a blister pack as described here.
[023] Figure 11A illustrates a rear view of a penetrating seal as described herein. Figure 11B illustrates a detachable seal as described herein.
[024] Figure 12 is a graph of data obtained from experiments that illustrate the Water Vapor Transmission Rate (WVTR) of the blister pack modality described here.
[025] Figure 13 illustrates a top view of a blister pack as described here.
[026] Figure 14 illustrates a thickness profile of a blister pack formed of a three-layer PVC-ACLAR-PVC material.
[027] Figure 15 illustrates a thickness profile of a blister pack formed of a two-layer PVC-ACLAR material.
[028] Figure 16 illustrates a thickness profile of a blister package formed of a two-layer CoPETG-ACLAR material.
[029] Figure 17 illustrates standard deviations for the graphs in Figures 14 to 16.
[030] The modalities of the present description are exemplary only and are not limited to the drawings described in Figures 1 to 17. Detailed Description of the Invention
[031] Described herein are blister packs configured to protect a cartridge or capsule containing a pharmaceutical formula for pulmonary delivery. Cartridges or capsules can be used in combination with an inhaler.
[032] Figure 1 illustrates an isometric view of an exemplary embodiment of blister pack 100 described herein. Blister pack 100 comprises a blister card or blister base plate 102 having a plurality of molded cavities 104, 104', 104'', 104''', 104'''', etc. arranged in one or more rows 106, 106', 106'', 106''', 106'''', etc. In one embodiment, three domes 108 may be present in each row 106. The cavity 104 may comprise a substantially round first end 108 and a somewhat flat area or ridge structure 110 which projects from the dome 108 and forms a retaining feature. cartridge cap 112 therein forming a notch or recess in the outer surface of the cavity. The dome 108 may be configured to accommodate a single-dose cartridge container or cup, and the boss 110 may be configured to contain and retain a section of a cartridge cap or top mount in a cartridge containment or pre-set configuration. -dosage. A pharmaceutical cartridge that can be packaged within may be that described, for example, in U.S. Patent. D613849 and US 2009/038390, the disclosures of which are fully incorporated herein because they all describe cartridges.
[033] The cartridge retention or protrusion aspect can hold a cap of a cartridge in place, and/or prevent cartridges in the multiple cartridge balls from contacting adjacent cartridges. In one embodiment, a cartridge stored in a blister unit is present wherein the cartridge comprises a cartridge cap and a container in a pre-dose or containment configuration, the cartridge container is fitted to the dome of the blister unit and suspended. by the cover adapted to the projection of the bubble. In this way, the cartridge holder is prevented from moving and held in the holding configuration.
[034] Figure 1 also illustrates a blister pack 100 containing five rows 106 each containing three cavities 104. This embodiment may be suitable for dosing three times a day to a patient. In some embodiments, a dose with each meal may be prescribed an inhaled dose of insulin or other medication for patients with a condition such as, but not limited to, diabetes. Alternative modalities may be used depending on the disease being treated.
[035] Other modalities may have one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen or fifteen cavities in each row. A blister pack may also include one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen or fifteen rows.
[036] The blister pack 100 illustrated in Figure 1 can be configured to seat with another blister pack so that the blisters from the opposing packs can intersperse between two rows 106 of the other pack in reducing the size of the outer pack during transport. The blister pack 100 may be joined with another blister pack facing backwards and upside down to reduce the size of the pack. Other means can be devised to reduce package size, volume, or the like.
[037] In some embodiments, bubbles can be configured to match the specific bubble size to be packaged. The size of the rows in a blister pack can also vary depending on factors such as number of blister holes and row size of blisters. In one embodiment, each bubble hole or cavity 104 may be greater than about 1 cm in length, greater than 1 cm in height at the dome 108, and greater than 1 cm in width. In one embodiment, the size of the cavity 104 can be about 1.5 cm wide, about 2.5 cm long, and about 1.5 cm high; wherein the rows 106 within a blister pack can be around 6 cm long and around 3.5 cm wide each. In this and other embodiments, cavities 104 may be centrally configured within a row of blisters or segment of a blister pack.
[038] Figures 2 and 3 illustrate opposite side views of blister pack 100 illustrated in Figure 1. Figures 2 and 3 illustrate uniform arrangement of rows 106 within blister pack 100. Figures 2 and 3 also depict comes the shape of dome 108 and plate 110 having what may be a substantially elongated general shape. The cavities 104 may have a flat end or ridge that extends laterally from a concave structure. Figures 2 and 3 also illustrate the base plate with bubbles 102 forming bubble holes or cavities 104 and the lid 114 is illustrated sealing cavities 104.
[039] Figure 4 is a bottom view of the blister pack 100 illustrated in Figure 1, illustrating the cavities 104 arranged within the blister pack 100. In that embodiment, the blister pack 100 comprises rows 106 configured having the space 116 between the rows 106. In one embodiment, the domes 106 of a first blister pack may fit in the space 116 between the rows 106 of a second blister pack and the projections 110 of the first blister pack may touch the projections 110 of the second blister pack.
[040] Figure 5 is a top view of the blister pack 100 illustrated in Figure 1, illustrating the lid seal 114 of the blister pack 100. The lid 114 can be attached or sealed so that the lid 114 can adhere to surfaces flats of the blister base plate 102. A portion of the blister base plate where the cap 144 can adhere is the space 116 between the cavities 104 and over each cavity opening. This adhesion of the cap 114 to the blister base plate 102 may close the blister pack 100 and encapsulate one or more cartridges within the cavities 104. In one embodiment, the cap 114 may be a single plate covering the entire base plate with bubbles 102 and binds within the PPB in the areas surrounding the cavities 104.
[041] In some embodiments, the cover 114 may adhere to the back of the bubble base plate 102 flush with the entire underside of the bubble base plate 102. In other embodiments, the cover 114 may adhere to the underside of the plate. blister base plate 102, but smaller than blister base plate 102. In still other embodiments, cap 114 may be larger than the underside of blister base plate 102 and wrapped around the edges. of the bubble base plate 102.
[042] Figures 6 and 7 are, respectively, front and rear views of blister pack 100 illustrated in Figure 1, illustrating blister pack 100 comprising row 106 that includes three combined cavities 104. Each cavity 104 may include the dome 108 and its lateral projection 110 with notches or cartridge retention aspects 112; wherein the rows of bubbles are sealed with cap 114.
[043] Figure 8 illustrates a cross section through a row of cavities as described in Figure 1 through plane 8 to 8. Figure 8 illustrates an inner part of three interconnected cavities and their relationship to each other within a row . That figure illustrates the inner volume 118 or row gap 106. Figure 8 also illustrates a view of an embodiment of blistered baseplate 102 illustrating the component layers. In that embodiment, the blister baseboard 102 comprises a three-layer film laminate that includes a first layer 120, second layer 122, and third layer 124. The three layers can be glued together. In other embodiments, more or less three layers can be used. For example, one, two, three, four, five, six, seven, eight, nine or ten layers can be used. In one embodiment, the number of layers used can be the number or thickness necessary to substantially prevent water ingress into the sealed package (bubble base plate and lid).
[044] In one embodiment, the bubble baseplate 102 may be manufactured using thermally deformable plastics. In certain embodiments, the blister baseboard 102 may be a thermally deformable laminate formed from films comprising a layer or more than one layer of a thermally deformable plastic, including polyester, polyvinyl chloride, and/or a fluoropolymer, such as ACLAR®. In other embodiments, blister pack 100 comprises a laminated composite comprising at least three layers selected from a layer of polyvinyl chloride, PET, and a layer of fluoropolymer, wherein at least one layer is a fluoropolymer. In one aspect of this embodiment, the blister baseplate 102 may be formed from one layer of fluoropolymer and two layers of polyvinyl chloride. In one embodiment, the first layer 120 can be polyvinyl chloride, the second layer 122 can be a fluoropolymer layer, and the third layer 124 can be polyvinyl chloride. In such an embodiment, the first layer 120 and the third layer 124, both of which are polyvinyl chloride layers, form the inner surface 126 and the outer surface 128 of each cavity 104.
[045] Other polymers that can be used alone or in combination with the above to form a blistered baseplate 102 may include poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly( ethylene-vinyl acetate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbona -to), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copolymer(ether-esters) (e.g. PEO/PLA), polyurethanes, silicones, polyesters, polyolefins, polyisobutylene and ethylene alpha olefin copolymers, acrylic polymers and copolymers, ethylene co-vinyl acetate, polybutylmethacrylate, vinyl halide and copolymers (e.g. polyvinyl chloride), polyvinyl esters (e.g. polyvinyl methyl ether), polyvinylidene halides (e.g. polyvinylidene fluoride and c polyvinylidene chloride), polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics (e.g. polystyrene), polyvinyl esters (e.g. polyvinyl acetate), styrene-acrylonitrile copolymers, ABS resins, polyamides (e.g. Nylon 66 and polycaprolactone), polycarbonates, polyoxymethylenes, polyimides, polyesters, polyurethanes, rayon, cellophane and carboxymethylcellulose.
[046] The bubble base plate 102 can be transparent, partially transparent or opaque. Partially transparent includes materials that allow around 5%, around 10%, around 15%, around 20%, around 30, around 40, around 50, around 60% , around 70%, around 80%, around 90% of light passage. Substantially opaque materials may allow no light to pass through and may be useful for housing light sensitive drugs.
[047] The thickness of the laminated material before forming the base plate with bubbles can be around 10 μm, around 25 μm, around 50 μm, around 75 μm, around 100 μm, in around 125 μm, around 150 μm, around 175 μm, around 200 μm, around 225 μm, around 250 μm, around 275 μm, around 300 μm, around 325 μm, around 350 μm, around 375 μm, around 400 μm, around 425 μm, around 450 μm, around 475 μm, around 500 μm, around 525 μm , around 500 μm, around 575 μm, around 600 μm, around 625 μm, around 650 μm, around 675 μm, around 700 μm, around 725 μm, in around 750 μm, around 775 μm, around 800 μm, around 825 μm, around 850 μm, around 875 μm, around 900 μm, around 925 μm, around 950 μm, around 975 μm, around 1000 μm, around 1025 μm, around 1050 μm, around 1075 μm, around 1100 μm, around 1125 μm, around 1150 μm, around 1175 μm, or around 1200 μm in thickness, or any thickness within a range limited by or between any of these values. In some embodiments, an overall thickness can range from around 100 μm to around 750 μm.
[048] Each layer in the laminated material can have a thickness and the total thickness of all layers represents the total thickness of the laminated material. Each layer can have a thickness of around 10 μm, around 25 μm, around 50 μm, around 75 μm, around 100 μm, around 125 μm, around 150 μm, around 175 μm, around 200 μm, around 225 μm, around 250 μm, around 275 μm, around 300 μm, around 325 μm, around 350 μm, around 375 μm, around 400 μm, around 425 μm, around 450 μm, around 475 μm, around 500 μm, around 525 μm, around 500 μm, around 575 μm, around 600 μm, around 625 μm, around 650 μm, around 675 μm, around 700 μm, around 725 μm, around 750 μm, around 775 μm, around 800 μm, around 825 μm, around 850 μm, around 875 μm, around 900 μm, around 925 μm, around 950 μm, around 975 μm, around 1000 μm, around 1025 μm, around 1050 μm, around 1075 μm, around 1100 μm, around 1125 μm, around 1150 μm, around 1175 μm or any thickness within a range limited by or between any of these values. In the modalities in which ALCAR is used, the thickness of the layers can vary from around 230 μm to around 720 μm in thickness.
[049] The bubble baseplate structure 102 can provide a required vapor and/or moisture barrier that can improve the stability of a pharmaceutical formulation, while also providing structural rigidity that resists leakage from the laminate. As noted above, the bubbled baseplate and the sealed lid combination can substantially prevent water ingress into the sealed package. The leakage of laminated material is a feature that prior art bubbles have when manufactured in the size and extent required to contain an inhaler cartridge of the sizes discussed here.
[050] The blister pack 100 in Figure 8 may also comprise a top or lid 114 which may be formed from a film or plate that includes one or more layers of a material. Suitable materials in making cap 114 can include, but are not limited to, a sheet material such as aluminum, copper, and/or polymer or copolymer. The polymers may include polyesters such as polyethylene terephthalate (PET) and/or modified polyethylene glycol terephthalate (PETG). Other polymers that can be used include poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(ethylene-vinyl acetate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride , poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly (iminocarbonate), copolymer (ethers ethers) (e.g. PEO/PLA), polyurethanes, silicones, polyesters, polyolefins, polyisobutylene and ethylene alpha olefin copolymers, acrylic polymers and copolymers, ethylene co-vinyl acetate, polybutylmethacrylate, vinyl halide and copolymers (e.g. polyvinyl chloride), polyvinyl esters (e.g. polyvinyl methyl ether), polyvinylidene halides (e.g. polyvinylidene fluoride and polyvinylidene chloride), polyacrylonitrile, ketones of polyvinyl, polyvinyl aromatics (eg e.g. polystyrene), polyvinyl esters (e.g. polyvinyl acetate), styrene-acrylonitrile copolymers, ABS resins, polyamides (e.g. Nylon 66 and polycaprolactone), polycarbonates, polyoxymethylenes, polyimides, polyesters, polyurethanes, “ rayon”, cellophane and carboxymethyl cellulose.
[051] The cover in Figure 8 comprises a two-layer film. However, in other embodiments, the cap 114 may include one, two, three, four, five, six, seven, eight, nine, or ten layers may be used. In one embodiment, the number of layers used can be the number or overall thickness needed to substantially prevent water ingress into a sealed package. The cap 114 may comprise an overall thickness from around 5 µm to around 100 µm, from around 10 µm to around 75 µm, or from around 20 µm to around 50 µm. Each layer of material used to form the cover 114 can be around 5 μm thick, at around 10 μm, around 20 μm, around 25 μm, around 30 μm, around 40 μm , around 45 μm, around 50 μm, around 55 μm, around 60 μm, around 65 μm, around 70 μm, around 75 μm, around 80 μm, in around 85 μm, around 90 μm, around 95 μm, or any thickness within a range limited by or between any of these values. In one embodiment, the cap 114 can be between about 30 µm and about 150 µm thick. In another embodiment, the cap 114 may be about 30 µm thick and manufactured from an outer layer 130 of soft tempered aluminum foil, a primer and a layer over lacquer, and an inner layer 132 of a heat-sealed polymeric coating. - you. The soft tempered blade can resist puncturing and tearing and can provide a level of durability to the packaging.
[052] Figure 9 illustrates a longitudinal cross-section of blister pack 100 comprising five rows of transverse cup blisters 108 in each of rows 106. In that figure, only a single layer 134 of polymer material is used to form baseboard with 102 bubbles, but as described above, more layers can be used. Cover 114 includes both outer layer 130 and inner layer 132. However, as described above, more or less layers can be used to form cap 114.
[053] In one embodiment, as illustrated in Figure 9, the cartridge 136 is molded to fit within a cavity 104. The cup portion 138 of the cartridge 136, in which a dry powder medication can be housed, can fit on dome 108 and top 140 of cartridge 136 may extend in combination of protrusion 110 and cartridge lid retaining feature 112. However, any cartridge may fit within a blister pack as described herein. Bubble base plates can be customized for additional fit and/or different cartridges.
[054] Figure 10 illustrates an embodiment in which a cartridge can be housed in an independent cavity 142. Here, the bubble base plate 144 can meet the cap 114 between each cavity 142, 142', 142''' in a row 106. As such, a channel 146 can be formed between each adjacent cavity 142 in which the blister base plate and the cap material can be bonded together. As above, each cavity here may further include a dome 108, a ridge 110, and the cartridge cap-retaining feature 112.
[055] Additionally, in Figure 10, the perforations 148 in the blister base plate 144 can be included so that the customer can tear a row of blister packs 100 to reduce the volume to transport. As in some embodiments, three doses per day may be prescribed, the simple detachment of a row from a blister pack can be a useful aspect of enough medicine for days. In other embodiments, perforations may be included that allow each cavity of the blister baseplate 144 to be removed individually.
[056] The connection between the cover 114 and the bubble base plate 144 (see Figure 9) may vary depending on the particular need. In one embodiment, the connection between the lid 114 and the bubble base plate 144 may be permanent such that the blade must be broken to access the contents of a cavity. As illustrated in Figure 11A, the cap 114 can be pierced 150 allowing the removal of individual cartridges from a particular cavity 104 in the blister base plate 144. In other embodiments that include the blister base plate 102 (Figure 4), the cap 114 can be pierced allowing several, for example three, cartridges to be developed.
[057] In another embodiment, the connection between the lid 114 and the bubble base plate 102 may be semi-permanent so that the blade can be repealed to access the contents of a cavity. As illustrated in Figure 11B, the cap 114 can be snapped off 152 allowing individual cartridges to be removed from a particular cavity 104 in the blister base plate 144. In other embodiments including the blister base plate 102, (Figure 4) the cap 114 can be snapped off allowing several, for example three, cartridges to be developed. In some embodiments, the latch hole 154 may be included so that after latching beyond the row 106, the cap can be torn from the latch hole 154 and discarded.
[058] In another embodiment described herein are methods of manufacturing blister packs as described herein in an automated in-line mode on a thermal blister forming machine available. The methods may comprise providing a base material or plate and a cover film; loading base material and cap film into the roll form machine, and processing base material and cap film on the machine. The process can be carried out according to the manufacturer's recommendations. In another embodiment, the base material is taken to a forming station where it can be formed using heat at a temperature ranging from around 120°C to around 150°C, or from around 120°C to around from 135°; and/or air pressure and mechanical plugs configured to form the cavities or bubble holes in a predetermined cycle, for example, between 10 and 30 cycles per minute, or in the range of 12 to around 25 cycles per minute. In one embodiment the air pressure can be adjusted to around 4 to around 7 bars, or from around 5 to around 6 bars. The heat, air pressure and mechanical plugs to use depend on the size of the bubble hole being made and the base material used. Cartridge product can be automatically loaded into the bubble cavities, then the cap stock is dragged over it. Together the filled and formed base material and the lid are dragged to the sealing station where the heated tools cause the sealing layer on the lid to activate, creating a sealed blister pack. After sealing, the formed filled bubble web is dragged to a punching station and then finally to a die cutting station which creates a final blister pack.
[059] In one embodiment, a blister pack can be designed to contain 5 cartridges filled with medication. In such an embodiment, cartridges filled with medication may be placed in five rows of three. In another embodiment, a base plate may be designed to hold 21 cartridges filled with medication. In such an embodiment, cartridges filled with medication may be placed in seven rows of three. Cartridges that can be used with blister packs may be pharmaceutical formulations intended for pulmonary delivery. In some embodiments, the pharmaceutical formulations that can be contained in the cartridges are in particular for delivering biologicals, including peptides and proteins, and other drugs that are sensitive to degradation. In some embodiments, the blister cartridge contains a formula comprising diketopyrazin such as those described in US Patent Nos. 7,794,754; 7,799,344, 7,803,404; 6,444,226; 6,555,127; 6,440,463, 6,428,771; 6,071,497; 5,352,461 and 5,503,852; and Patent Applications Nos. 12/813839 (US 2010/317574) and WO 2010/144789, the disclosures of which are fully incorporated herein as they all relate to diketopyrazin and drug formulations. An exemplary diketopyrazin includes diketopyrazine fumaryl (bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketo-diketopiperazine; FDKP). An FDKP is a diketopyrazine used for pulmonary applications and has a formula:

[060] FDKP provides a beneficial microparticle matrix because it has low acid solubility but is readily soluble at neutral or basic pH. These properties allow FDKP to crystallize and the crystals for self-assembly to microparticle form under acidic conditions and are suitable for pulmonary distribution that have a diameter between around 0.5 to around 10 microns can reach the lungs, passing successfully overcome most natural barriers. Cartridges containing formulas for pulmonary delivery that comprise diketopyrazin salts such as those described in U.S. Patent. 7,820,676 and other formulas for using the cartridges may also be packaged in the present blister pack.
[061] In one embodiment, a method is described for assembling blister packs containing a cartridge in each blister. In one embodiment, the cartridge may be a two-part cartridge (as described above) comprising a container or cup and a lid or top as illustrated and described in U.S. Patent. D6134849 and U.S. Patent Application Serial No. 12/484,137 (US 2009/0308392), respectively. The cartridge may also comprise a containment or pre-dosing configuration and a dosing configuration. In the present embodiments, the method comprises providing cartridges consisting of two injection molded parts, each cartridge comprising a lid and a cup; fill the cup with a medicated formula. Place a cartridge cap over the cup, and lock the top to the cup in a transport or containment configuration so that the medication powder is sealed in the cup. In this and other embodiments, the blister pack is designed to transport the cartridges while preventing premature movement of the cartridge cup in a dosing configuration.
[062] Therefore, blister packs can be designed to prevent movement of the cartridge within the blister cavity which is achieved by forming a series of aspects formed in the blister cavity that fit each cartridge into the blister hole and It also prevents them from touching. In this and other embodiments, blister pack 100 may be configured so that each blister or cavity 104 comprises ridge area 110 wherein the cartridge cap in a containment configuration can rest on ridge area 110, which successively allows the cup to be suspended in the dome 108 or circular gap of the bubble, protecting a medicament product from mechanical shock. In that embodiment, the cup of the blister cartridge may be surrounded on all sides by the dome-like appearance, and it may not be possible for the lid to slide into the dosing position while the cartridge is in the blister pack.
[063] In one embodiment, the blister pack 100 may also be designed and configured to mate with blisters from another blister pack so as to reduce the size of the pack delivered during shipment and storage of the product. In one embodiment, the method comprises rotating or shaking a blister pack 100 so that a pair of blister packs can turn their cavities towards each other then join them so that the undersides of the blister protrusion areas 110 in the opposing blisters make contact. This arrangement may allow the pair of blister packs to be wrapped together in a smaller footprint than if the blister packs were simply stacked. In one embodiment, a pharmaceutical package may comprise one or more blister packs as described herein; wherein the blister pack is enclosed in a rolled foil and the rolled foil comprises a soft tempered aluminum material.
[064] In an exemplary mode. 100 blister pack can be used for three times a daily use for a five day supply. Such blister pack consists of five thermally formed cavities 104 designed to hold three cartridges filled with medication 136 each per row 106. Each cavity 104 of three cartridges may be an area extending about five millimeters that forms a seal in all four sides and the sealing tool can be serrated to also increase the total sealing area.
[065] A perforation, as described above, may be provided between each blister unit, including a section, or row 106 so that each section can be separated from the adjacent section. The individual cavities 104 of, for example, one, two, three or more cartridges can be carried discreetly in a pocket or bag. In this way, an end user can carry medication only as much as is needed for a particular dosing event. In one embodiment, to remove a cartridge, the user presses on a bubble dome with a thumb or finger; causing the cartridge to break through the soft blade cap. This method of bubble removal is commonly called “push through”. If done carefully, a single cartridge can be removed from a common cavity of, for example, three that has a contiguous volume without displacing the other two. Alternative settings can be made depending on the drug to be delivered and the number of required doses that a patient will need over a period of time.
[066] In some embodiments, the processed blister packs may have laminate thicknesses of thickness in a manner that is reproducible thick through the cavities. In some embodiments, the standard deviation can be between around 0.004 mm and around 0.023 mm.
[067] In other embodiments, once sealed, a blister pack described here can resist substantially all the ingress of water for a period of around 1 week, around 1 month, around 6 months, around 1 year, around 2 years, around 3 years, around 4 years or around 5 years. For example, less than about 0.05g, less than about 0.05g, less than about 0.02g, less than about 0.01g, less than about 0.001g or less of around 0.0001 g of water can flow into a sealed blister pack or medication. In another embodiment the blister packs described herein may resist the transmission of water stored at a chilled temperature, for example at 4°C.
[068] In some embodiments, the water vapor transmission rate may be less than around 9.005 g of water per package per day. In other embodiments, the water transmission rate may be less than around 0.003 g, 0.002 g, 0.001 g, 0.0005 g, 0.00001 g or 0.000005 g of water per package per day. In one embodiment the water transmission is less than around 4.0x10-5 g of water per pack per day.
[069] The water vapor transmission rate can also be affected by the storage temperature. The blister packs described here can resist water transmission when stored at temperatures between around 10°C and around 35°C, around 15°C and around 30°C, around 20°C C and around 25°C. In one embodiment, the blister packs described herein can resist water transmission when stored at room temperature.
[070] In one embodiment, the blister packs are not only sealed, but a cartridge within the blister pack may also have a sealed container including a drug. In some embodiments, the drug is a dry powder as described herein. In some embodiments, this dry powder can resist substantially all the ingress of water for a period of around 1 week, around 6 months, around 1 year, around 2 years, around 3 years, around 4 years, around 5 years or around 10 years. Example 1 Manufacture of Blister Packaging Assembly
[071] Rolls of base material or plate and cover film are provided in connection with the commercial thermal former (Pharmworks TF-2X). The base material consists of a fluoropolymer layer sandwiched between two layers of polyvinyl chloride manufactured by Klockner Pentaplast of America. The base material is drawn to a forming station at a rate of around 12 to 25 cycles per minute (cpm), where it is formed using a combination of heat, air pressure and specifically designed mechanical plugs to the required dimensions to build the bubbles as defined in the Figures. In this example, the temperature to soften the plastic to form the bubble holes ranges from around 130°C to around 150°C. Cartridges containing the pharmaceutical formula are automatically loaded into the blister cavities, then the cap stock consisting of tempered soft aluminum foil (Alcan) is pushed over this assembly. Along with the formed and filled base material and the cover they are pushed to the sealing station where the tools heated to temperatures ranging from around 150°C to around 179°C and pressure cause the sealing layer on the cover to activate. , creating a sealed bubble. After sealing, the formed and filled blister web is pushed to a punching station and then finally to a die cutting station which creates the final blister pack. Example 2 Water Vapor Transmission Rates from Blister Packs
[072] The blister packs manufactured in Example 1 were tested for water vapor transmission rate. Sealed blister packs comprising a three-layer blister baseplate comprised an outer and inner layer of polyvinyl chloride and an intermediate layer of ACLAR and a soft temper foil lid were compared to blister packs made from of a bubble base plate consisting of a single layer of PET similar in gauge in thickness to the three layer bubble base plate and having a soft tempered blade cover. Each blister pack received an injection of 3 laminated material of water (1 laminated material in each of the three blisters) using a syringe with a 29 gauge needle (0.33 mm x 13 mm) through the base of the pack. of bubbles. After injecting water, the hole in the base material was plugged with fast-curing epoxy adhesive. The water vapor that passed through the package was analyzed over a period of time by passing a stream of clean dry nitrogen gas over the package in a sealed glass container and measuring the amount of moisture collected by the nitrogen gas. The measurement of water vapor passing through the package and released into the sealed pot was analyzed at the beginning of the experiment and for a period of time afterwards in a Mocon Permatran device.
[073] Figure 12 is a graph depicting data from the experiment illustrating the typical Water Vapor Transmission Rate (WVTR) of blister packs in which grams of moisture per day are illustrated on the vertical geometric axis, and the points time tested are shown on the horizontal axis. Curve A (three-layer bubble baseplate comprising ACLAR) and curve B (PET bubble baseplate) illustrate the results of the experiments. The data illustrate that after a short period of time where the test instrument itself clears itself of air, the WVTR quickly stabilizes to a level where the water vapor transmission rate is stable and barely detectable after six days of testing. . This demonstrates that packaging integrity is acceptable over time. The comparative data of the blister made using conventional PET laminates is illustrated in Figure 12, curve B illustrates that this material is not effective in preventing moisture transmission through the packaging. It can be seen in Figure 12 that the initial peak associated with curve A is water vapor present in the pot (atmospheric) at the beginning of the experiment, which requires around 12 hours to evacuate. Example 3Baseplate Cavity Uniformity with Bubbles
[074] In these experiments, three baseboard laminates were fabricated with different bubbles similar to those described in Example 1, using a temperature setting ranging from 120 to 125°C to manufacture the bubbled baseboards and a temperature setting ranging from 120 to 125°C. sealing temperature between 155 and 165°C in cycles of 12 to 25 per minute and at an air pressure of around 6 bars. The thickness of the bubble baseplate wells was measured at various locations as indicated in Figure 13 to determine the integrity and uniformity of the bubbles or wells.
[075] Figure 14 is a graph illustrating the thickness at different locations listed in Figure 13 along the line in cross section. The bubble baseboard here is formed from a three-layer laminate of PVC-ACLAR-PVC (7.5 mil-3.0 mil-7.5 mil; 0.19 mm-0.07 mm-0.19 mm). The thinnest point on the bubble baseplate is situated at the peak of the dome (around 0.175mm to around 0.075mm) and the thickest spots are situated on the ridges (around 0.275mm to around 0.225mm ).
[076] Figure 15 is a graph illustrating the thickness at different locations listed in Figure 13 along the line in cross section. The bubble baseboard here is formed from a two-layer PVC-ACLAR laminate (15 mil-4.0 mil; 0.38 mm-0.10 mm). The thinnest point on the bubble baseplate is situated at the peak of the dome (around 0.187mm to around 0.125mm) and the thickest spots are situated on the protrusions (around 0.225mm to around 0.275mm ).
[077] Figure 16 is a graph illustrating the thickness at different locations listed in Figure 13 along the line in cross section. The bubble baseboard here is formed from a two-layer laminate of CoPETG-ACLAR (12 mil-4.0 mil; 0.30 mm-0.10 mm). The thinnest point on the bubble baseplate is situated at the peak of the dome (around 0.125mm to around 0.165mm) and the thickest spots are situated on the protrusions (around 0.200mm to around 0.275mm ).
[078] The standard deviations for the various measurements in Figures 14 to 16 are illustrated in the graph in Figure 17. Based on the graphs in Figures 14 to 17, it can be understood by those versed in the technique that the thickness of the bubbled baseplate processed can be reproduced with standard deviations between around 0.004 and around 0.023 mm. The signal to noise in the same samples can vary from around 0.020 to around 0.135. Example 4 Moisture Vapor Penetration
[079] A blister baseplate with a foil casing was selected due to its vapor penetration characteristics and the ability to form a suitable tight package.
[080] Supplier specifications for moisture vapor penetration characteristics of blister packaging materials may be less than 0.058g water/m2/day for a laminated base film, less than 0.010g water/ m2/day for a laminated lid less than 0.010 g water/m2/day for a laminated wrapper in accordance with ASTM F1249 at 37.8°C/90%RH.
[081] A sealed assembly consisting of the bubbled baseplate and blade housing was individually tested in accordance with ASTM Method F1249 - Standard Test Method for Water Vapor Transmission Rate through Plastic Film and Cover Using a Modulated Infrared Sensor. Bubble baseplate samples were prepared by injecting 1 cc of water into each bubble strip and placing an impermeable epoxy resin over the opening created by the syringe. This created a water deposit inside the bubble card. Slide wrap packs containing blister packs were prepared by injecting 1 cc of water into the wrap and placing an impermeable epoxy resin over the opening created by the syringe. Penetration characteristics were determined by placing a sample in a Mocon Permatran instrument chamber, and flushing the top space of the chamber with dry air. The escaping water vapor can propagate and permeate through the sealed test samples and mix with the gas within the headspace of the chamber and is transported to an infrared sensor. The infrared sensor measures the fraction of infrared energy absorbed by the water vapor and produces an electrical signal whose amplitude is proportional to the water vapor concentration. The amplitude of the electrical signal produced by the test samples is then compared to the signal produced by measuring a calibration film with a known water vapor transmission rate. This information is then used to calculate the rate at which moisture is transmitted through the material being tested. The test was conducted at 25°C/100%RH.
[082] Described here is a bubble baseboard that has a layer of three laminates of ACLAR unthought of by the PVC layers as the outer layers exhibit a moisture penetration rate around 0.00004 g water/ blister pack/day, and the moisture penetration rate in the sealed assembled wrapper package is around 0.040 g water/package wrapper/day. These low values demonstrate the suitability of the packaging configuration for cartridges containing pharmaceutical formulations. The packaging configuration was confirmed in practice during long stability studies by testing Powder Tl for moisture content. The data shows no perceptible change in moisture content and stability in any condition (5°C or 25°C/60°%RH), validating the suitability for use of the blister card with the blister pack configuration. foil wrapper with TECHNOSPHERE® Insulin (Mannkind Corp., CA).
[083] While the invention has been particularly illustrated and described with reference to particular embodiments, it should be appreciated that variations of the above-described and other features and functions, or alternatives thereof, may be desirably combined in many other systems or systems. different applications. Also, various alternatives, modifications, variations or improvements not envisaged at the time may subsequently be made by those skilled in the art which are also intended to encompass the claims which follow.
[084] Unless otherwise indicated, all numbers expressing amounts of ingredients, properties such as molecular weight, reaction conditions, and so on used in the report and claims are to be understood to be modified in all cases by the term “around”. Therefore, unless otherwise indicated, the numerical parameters described in the report and in the appended claims are approximations which may vary depending on the described properties sought by the present invention. Finally, and not in an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter must at least be constructed in light of the series of reported significant digits and by the application of common rounding techniques.
[085] The terms “a”, “an”; “the”, “a” and similar references used in the context of describing the invention (especially in the context of the claims that follow) should be considered to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by the context. Mentioning ranges of values in context simply serves as a shorthand method of referring individually to each separate value that falls within the range. Unless otherwise indicated in the context, each individual value is incorporated in the report as if it were mentioned here individually. All methods described herein may be performed in any suitable order, unless otherwise indicated in the context or otherwise clearly contradicted by the context. The use of any and all of the examples, or exemplary language (e.g., "such as") provided herein is intended merely to elucidate the invention and not to limit the scope of the invention otherwise claimed. No language in the report should be deemed to indicate any unclaimed essential to the practice of the invention.
[086] The groupings or alternative elements or modalities of the invention described herein should not be considered as a limitation. Each group member may be referred to and claimed individually or in any combination with other group members or other elements found herein. It is expected that one or more elements of a group may be included in, or excluded from, a group for reasons of convenience and/or patentability. When any inclusion or exclusion occurs, the report is deemed to contain the group as modified, thereby meeting the written description of all Markush groups used in the attached claims.
[087] Described herein are certain embodiments of this invention including the best known mode for carrying out the invention. Naturally, variations on these described embodiments will become clear to those skilled in the art upon reading the preceding description. It is expected that skilled persons will employ such variations as appropriate, and that the invention will be practiced otherwise than specifically described herein. Therefore, the invention includes all modifications and equivalences of the subject matter described herein in the appended claims as permitted by applicable law. Furthermore, any combination of the above-described elements in all possible variations thereof is encompassed by the invention, unless otherwise indicated herein or clearly contradicted by context.
[088] In addition, numerous references to patents and publications in print are made throughout this report. Each of the above-cited references and printed publications are entirely individually incorporated in context by reference.
[089] In closing, it should be understood that the embodiments of the invention described herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not limitation, alternative configurations of the present invention may be used in accordance with the present teachings. Therefore, the present invention is not limited to what has been precisely shown and described.

权利要求:
Claims (26)
[0001]
1. Bubble pack (100), CHARACTERIZED in that it comprises a base plate with bubbles (102) comprising: one or more cavities (104) having a void, a concave structure (108) , a protrusion (110), an inner surface, and an outer surface, wherein each of the one or more cavities (104) is configured to grip, and a cartridge containing a pharmaceutical formula comprising a diketopiperazine and an active ingredient; a cap (114) connected to said blister pack (100); wherein the one or more cavities (104) have an outer surface and an inner surface, and wherein the protrusion (110) includes a notch in the outer surface.
[0002]
2. Blister pack (100), according to claim 1, CHARACTERIZED in that the notch is an aspect of superior cartridge retention (112) on the inner surface of the cavities (104).
[0003]
3. Blister pack (100), according to claim 1, FEATURED in that the protrusion (110) extends from the concave structure (108) and forms a flat end of the one or more cavities (104 ) and said notch forming a cartridge retaining feature (112) on the inner surface of the one or more cavities (104).
[0004]
4. Blister pack (100), according to claim 1, FEATURED in that the cartridge comprises a container and a lid or a top that extends over the container.
[0005]
5. Blister pack (100), according to claim 1, FEATURED by the fact that diketopiperazine is bis—3,6-(N-fumaryl-4-aminobutyl)-2,5-diketo-diketopiperazine.
[0006]
6. Blister pack (100), according to claim 1, CHARACTERIZED by the fact that the active ingredient is a peptide, protein, small molecule or a nucleic acid.
[0007]
7. Blister pack (100) according to claim 1, FEATURED in that the active ingredient is selected from the group consisting of insulin, glucagon type peptide 1, glucagon, oxytocin, oxytomodulin, peptide YY, sumatriptan, a peptidyl peptidase IV inhibitor, parathyroid hormone, deoxyribonuclease I and active fragments or analogues thereof.
[0008]
8. Blister pack (100), according to claim 7, FEATURED in that the active ingredient is at least one of insulin, peptide type 1 glucagon, glucagon and a peptidyl peptidase IV inhibitor.
[0009]
9. Blister pack (100), according to claim 8, CHARACTERIZED by the fact that the active ingredient is insulin.
[0010]
10. Blister pack (100), according to claim 8, FEATURED by the fact that the active ingredient is peptide type 1 glucagon.
[0011]
11. Blister pack (100), according to claim 8, FEATURED by the fact that the active ingredient is glucagon.
[0012]
12. Blister pack (100), according to claim 7, FEATURED by the fact that the active ingredient is at least one of oxytocin, oxytomodulin and peptide YY.
[0013]
13. Blister pack (100), according to claim 12, CHARACTERIZED by the fact that the active ingredient is oxytocin.
[0014]
14. Blister pack (100), according to claim 12, FEATURED by the fact that the active ingredient is oxytomodulin.
[0015]
15. Blister pack (100), according to claim 12, FEATURED by the fact that the active ingredient is peptide YY.
[0016]
16. Blister pack (100), according to claim 1, FEATURED in that the blister base plate (102) comprises at least three layers selected from polyvinyl chloride and ACLAR.
[0017]
17. Blister pack (100), according to claim 16, FEATURED by the fact that the ACLAR layer forms the intermediate layer of the blister base plate (102) which has a thickness of 230 μm at 720 µm. .m thick.
[0018]
18. Blister pack (100), according to claim 1, FEATURED in that the lid (114) comprises a sheet comprising one or more selected layers of aluminum, plastic polymer or co-polymer.
[0019]
19. Blister pack (100), according to claim 18, CHARACTERIZED by the fact that the lid (114) has a thickness of 10 μm at 75 µm. m.
[0020]
20. Blister pack (100), according to claim 1, FEATURED by the fact that the blister base plate (102) has a thickness greater than 100 μm.
[0021]
21. Method of manufacturing the blister pack (100) as defined in claim 1, wherein the blister pack (100) is configured to house one or more cartridges containing a pharmaceutical formula, CHARACTERIZED in that it comprises: binding a film the bubble base plate (102), wherein the one or more cavities (104) are molded into the bubble base plate (102) which comprises at least three selected layers of polyvinyl chloride and ACLAR; wherein the cartridge comprises a container and an upper part is in the one or more cavities (104) when the film is bonded to the blister base plate (102); and wherein the blister base plate (102) is optionally perforated to segment the cavities (104) from one another.
[0022]
22. Method, according to claim 21, CHARACTERIZED by the fact that the pharmaceutical formula comprises an active ingredient.
[0023]
23. Method, according to claim 22, CHARACTERIZED by the fact that the pharmaceutical formula comprises a diketopiperazine.
[0024]
24. Method according to claim 23, CHARACTERIZED by the fact that diketopiperazine is bis—3,6-(N-fumaryl-4-aminobutyl)-2,5-diketo-diketopiperazine.
[0025]
25. Method according to any one of claims 22 to 24, CHARACTERIZED in that the active ingredient is a peptide, protein, small molecule or a nucleic acid.
[0026]
26. Method according to any of claims 22 to 24, FEATURED in that the active ingredient is selected from insulin, peptide type 1 glucagon, glucagon, oxytocin, oxytomodulin, peptide YY, sumatriptan, a peptidyl inhibitor peptidase IV, parathyroid hormone, deoxyribonuclease I, and active fragments or analogues thereof.

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