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CN-119731028-B - Application package and method for its production

CN119731028BCN 119731028 BCN119731028 BCN 119731028BCN-119731028-B

Abstract

The present invention relates to an application package and a method for its production. The application package includes a base portion and a cover obtained from a multilayer film.

Inventors

  • M-A. Claire

Assignees

  • 勃林格殷格翰动物保健有限公司

Dates

Publication Date
20260508
Application Date
20230925
Priority Date
20220930

Claims (20)

  1. 1. An administration package (1) for a pharmaceutical product (2), comprising: a bottom part (3), the bottom part (3) having a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) surrounding the cavity (5), A cover (4) covering and completely closing the cavity (5), A predetermined breaking zone (9) for opening the application package (1) by breaking the breaking zone (9), Wherein the bottom part (3) is formed from a plastic sheet (200) in the form of a multilayer film, and Wherein the cover (4) is a cover sheet (300) in the form of a multilayer film, Wherein the plastic sheet (200) of the bottom part (3) comprises at least 5 layers: an outer thermoformable layer (201), A cycloolefin copolymer (COC) layer (202), wherein the cycloolefin copolymer (COC) is obtained by copolymerization of a cyclic monomer of 8,9, 10-triazacyclopentene (norbornene) or 1,2,3, 4a,5,8 a-octahydro-1, 4:5, 8-dimethylnaphthalene (tetracyclododecene) with ethylene, An inner thermoformable layer (203), A barrier layer (204), and A sealing layer (205), and Wherein the cyclic olefin copolymer layer (202) is arranged between the outer thermoformable layer (201) and the inner thermoformable layer (203), and wherein the barrier layer (204) is arranged between the sealing layer (205) and the inner thermoformable layer (203).
  2. 2. The application package (1) according to claim 1, wherein the outer thermoformable layer (201) comprises or consists of a polymer selected from the group consisting of Polystyrene (PS), polyvinyl chloride (PVC), amorphous polyethylene terephthalate (APET), ethylene Butyl Acrylate (EBA), ethylene Vinyl Acetate (EVA), polypropylene (PP), polyethylene (PE), low Density Polyethylene (LDPE), linear Low Density Polyethylene (LLDPE) and mixtures thereof.
  3. 3. Application package (1) according to claim 1, wherein the outer thermoformable layer (201) and the inner thermoformable layer (203) are composed of the same polymer.
  4. 4. The application package (1) according to claim 1, wherein the barrier layer (204) comprises a polymer selected from the group consisting of ethylene vinyl alcohol (EVOH), ethylene Vinyl Acetate (EVA), polyvinylidene chloride (PVDC), polytrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl Methacrylate (EMA), ethylene Butyl Acrylate (EBA), ethylene Ethyl Acrylate (EEA), poly (methyl methacrylate) (PMMA), ethylene/methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.
  5. 5. The application package (1) according to claim 1, wherein the sealing layer (205) comprises a polymer selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low Density Polyethylene (LDPE), linear Low Density Polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very Low Density Polyethylene (VLDPE), ionomers of acid copolymers, ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethyl Methacrylate (EMA), ethylene vinyl alcohol (EVOH) or mixtures thereof.
  6. 6. The application package (1) according to claim 1, wherein the cyclic olefin copolymer layer (202) has a thickness in the range from 200 to 600 μιη.
  7. 7. Application package (1) according to claim 1, wherein the thickness of the cyclic olefin copolymer layer (202) relative to the thickness of the outer thermoformable layer (201) and/or the thickness of the inner thermoformable layer (203) is in the range of 5:1 to 30:1.
  8. 8. Application package (1) according to claim 1, wherein the plastic sheet (200) of the bottom portion (3) comprises an intermediate layer (206).
  9. 9. Application package (1) according to claim 1, wherein the plastic sheet (200) of the bottom portion (3) comprises at least 5 layers with the following layer sequence: the outer thermoformable layer (201) is followed by The cycloolefin copolymer (COC) layer (202) is followed by The inner thermoformable layer (203) is followed by Optionally, the intermediate layer (206) is followed by The barrier layer (204) is followed by The sealing layer (205).
  10. 10. The application package (1) according to claim 9, wherein the outer thermoformable layer (201) comprises a polymer selected from the group consisting of Polystyrene (PS), polyvinyl chloride (PVC), amorphous polyethylene terephthalate (APET), ethylene Butyl Acrylate (EBA), ethylene Vinyl Acetate (EVA), polypropylene (PP), polyethylene (PE), low Density Polyethylene (LDPE), linear Low Density Polyethylene (LLDPE), and mixtures thereof.
  11. 11. The application package (1) according to claim 9, wherein the plastic sheet (200) comprises the following layer structure having the following layer sequence: (a) An outer thermoformable layer (201) comprising PP, followed by (B) A cycloolefin copolymer layer (202) comprising COC is followed by (C) An inner thermoformable layer (203) comprising PP, followed by (D) Optionally, the intermediate layer (206) comprising PE, followed by (E) Barrier layer (204) comprising EVOH, followed by (F) A sealing layer (205) comprising PE.
  12. 12. The application package (1) according to claim 1, wherein the cover sheet (300) comprises the following layers: a protective layer (301), A first barrier layer (302), An intermediate layer (303), A second barrier layer (304) A sealing layer (305), Wherein the first barrier layer (302) is arranged between the protective layer (301) and the intermediate layer (303), and wherein the second barrier layer (304) is arranged between the intermediate layer (303) and the sealing layer (305).
  13. 13. Application package (1) according to claim 1, wherein the cover sheet (300) comprises the following layer structure with the following layer sequence: (i) The protective layer (301) is followed by (Ii) The first barrier layer (302) is followed by (Iii) The intermediate layer (303) is followed by (Iv) The second barrier layer (304) is followed by (V) A sealing layer (305).
  14. 14. Application package (1) according to claim 1, wherein the cover (4) and the bottom part (3) are at least partly joined by means of the plastic sheet (200) of the bottom part (3) and the sealing layer (205, 305) of the cover sheet (300) of the cover (4).
  15. 15. Application package (1) according to claim 1, wherein the plastic sheet (200) of the bottom portion (3) comprises the following layer structure: (a) An outer thermoformable layer (201), (B) A cycloolefin copolymer layer (202), (C) An inner thermoformable layer (203), (D) An intermediate layer (206), (E) A barrier layer (204), and (F) A sealing layer (205), and Wherein the cover sheet (300) comprises the following layer structure: (i) A protective layer (301), (Ii) A first barrier layer (302), (Iii) An intermediate layer (303), (Iv) A second barrier layer (304) (V) A sealing layer (305).
  16. 16. Application package (1) according to claim 1, wherein the plastic sheet (200) of the bottom portion (3) comprises the following layer structure having the following layer sequence: (a) An outer thermoformable layer (201), followed by (B) A cycloolefin copolymer layer (202) is followed by (C) An inner thermoformable layer (203), followed by (D) Optionally, the intermediate layer (206) is followed by (E) Barrier layer (204), followed by (F) A sealing layer (205), and Wherein the cover sheet (300) comprises the following layer structure: (i) The protective layer (301) is followed by (Ii) The first barrier layer (302) is followed by (Iii) The intermediate layer (303) is followed by (Iv) The second barrier layer (304) is followed by (V) A sealing layer (305).
  17. 17. A method for producing and filling an application package (1) for a pharmaceutical product (2), Wherein the application package (1) has a bottom portion (3), the bottom portion (3) having a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) surrounding the cavity (5), Wherein the application package (1) has a cover cap (4), the cover cap (4) covering and completely closing the cavity (5), Wherein the application package (1) has a predetermined breaking zone (9) for opening the application package (1) by breaking the breaking zone (9), Wherein the bottom part (3) is formed from a plastic sheet (200) in the form of a multilayer film, and wherein the cover (4) is a cover sheet (300) in the form of a multilayer film, Wherein the plastic sheet (200) of the bottom part (3) comprises at least the following 5 layers: an outer thermoformable layer (201), A cycloolefin copolymer (COC) layer (202), wherein the cycloolefin copolymer (COC) is obtained by copolymerization of a cyclic monomer of 8,9, 10-triazacyclopentene (norbornene) or 1,2,3, 4a,5,8 a-octahydro-1, 4:5, 8-dimethylnaphthalene (tetracyclododecene) with ethylene, An inner thermoformable layer (203), A barrier layer (204), A sealing layer (205), Wherein the cycloolefin copolymer layer (202) is arranged between the outer thermoformable layer (201) and the inner thermoformable layer (203), and wherein the barrier layer (204) is arranged between the sealing layer (205) and the inner thermoformable layer (203), The method comprises the following steps: heating a multilayered plastic sheet (200) at least partially, Forming a bottom portion (3) of the application package (1) by stretching the plastic sheet (200) onto and/or into a moulding tool (102), the bottom portion (3) having a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) surrounding the cavity (5), A predetermined breaking zone (9) is created in the bottom part (3) using the moulding tool (102) and/or during the step of forming the bottom part (3), Filling the cavity (5) with the pharmaceutical product (2), and Covering the cavity (5) with a cover (4) and fixing the cover (4) to the rim (8) such that the cavity (5) is completely closed.
  18. 18. The method according to claim 17, wherein the cavity (5) comprises a chamber (6) and an application channel (7) in fluid communication with the chamber (6).
  19. 19. Method according to claim 17, wherein the predetermined breaking zone (9) is formed only in the area of the cavity (5).
  20. 20. An administration package (1) for a pharmaceutical product (2), comprising: a bottom part (3), the bottom part (3) having a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) surrounding the cavity (5), and A cover (4) covering and completely closing the cavity (5), Wherein the bottom part (3) is formed from the plastic sheet (200) in the form of a multilayer film, Wherein the plastic sheet (200) of the bottom part (3) comprises at least the following 5 layers: an outer thermoformable layer (201), A cycloolefin copolymer (COC) layer (202), wherein the cycloolefin copolymer (COC) is obtained by copolymerization of a cyclic monomer of 8,9, 10-triazacyclopentene (norbornene) or 1,2,3, 4a,5,8 a-octahydro-1, 4:5, 8-dimethylnaphthalene (tetracyclododecene) with ethylene, An inner thermoformable layer (203), A barrier layer (204), A sealing layer (205), Wherein the cyclic olefin copolymer layer (202) is arranged between the outer thermoformable layer (201) and the inner thermoformable layer (203), and wherein the barrier layer (204) is arranged between the sealing layer (205) and the inner thermoformable layer (203).

Description

Application package and method for its production Technical Field The present invention relates to an application package for preferably liquid pharmaceutical products and to a method for producing and filling an application package and to the use of a plastic sheet for producing an application package. The application package is produced in particular by thermoforming. Thermoforming is a process in which a plastic sheet, particularly a film or foil, is heated to a bendable forming temperature and then formed into a specific shape in a mold. Furthermore, the plastic sheet is preferably trimmed after molding in the mold. Administration packages, particularly for liquid pharmaceutical products, which house the product or store the product therein and which may also be used for administration of the product to a patient. The package is in particular a pipette or can be used as or converted into a pipette. The pharmaceutical product is preferably a liquid and/or a product to be applied to the skin and/or fur of a patient, preferably a domestic animal, such as a cat or dog. Background EP 2,998,098 A1 and EP 2,998,099 A1 relate to a method for producing and filling an administration package for a liquid pharmaceutical product. The package is produced by a thermoforming process in which a deep-drawn film is heated in order to plasticize the film at least in the sub-areas, the plasticized areas are deep-drawn into a molding tool to form a chamber for the product and a sleeve-like application channel leading to the chamber, the product is introduced into the chamber, and the filled deep-drawn film is covered with a cover film in order to close the chamber and the application channel. In one end region, the application channel is provided with a slit or groove forming a predetermined breaking zone where the tip of the application channel can be broken in order to open the application package. The predetermined fracture zone is created prior to heating the deep drawn film. The deep drawn film has a laminated composite film of a layer of polypropylene (PP) and a layer of acrylonitrile-methacrylate copolymer (AMAB) and is slit or grooved by cutting through the PP layer. The method disclosed in EP2 998 098 A1 and EP2 998 099 A1 has several disadvantages. First, to avoid any undesired interactions of the solvent or active ingredient of the pharmaceutical product with the package, only specific combinations of plastic films may be used for the cover film as well as for the deep drawn film. The same applies to the breaking zone, only specific combinations of materials can be used to ensure that a complete break at the breaking zone is reproducibly obtained and an available pipette ready for application. Unfortunately, the brands mentioned in EP 2 998 098 A1 or EP 2 998 099A1, respectivelyThe specific acrylonitrile-methacrylate copolymer (AMAB) distributed is no longer available. Furthermore, the creation of grooves requires an additional step in addition to the thermoforming step to form the chambers and application channels. Finally, the method of creating predetermined breaking zones by cutting through the PP layer does not work when the film has a composition different from the one described and/or the setup of a system for cutting is more complex. Thus, there is a need for a new material combination that enables such disposable administration packages to be used in liquid pharmaceutical products. U.S. patent application US2012/0265159 A1 describes devices for storing and dispensing agents, and more particularly describes a device that can be used to dispense a parasiticidal agent to the skin of an animal. Of particular interest is the configuration of the packaging device, which is designed such that it includes a wall or second layer coupled to a substrate or first layer, wherein the substrate and the wall define a medicament reservoir. At least a portion of the wall or the second layer is configured to deform when the wall is actuated to reduce a volume of the medicament reservoir such that dispensing of a medicament from the device is facilitated. In view of the materials that may be included in the first or second layers of the device, only the first and/or second layers, and any other layers, walls, and structures included within any of the medicament containers described, may be composed of any suitable materials. Such materials may be selected to minimize interactions with the agent, may be composed of a substantially inert and/or flexible polymer, or may be composed of a polymer having a particular hardness. However, the material is not relevant to one possible opening mechanism of the described device and, in particular, is not targeted to a potential or all possible uses in designing a context of a predetermined fracture zone. German utility model DE 201 16 3417 u1 describes polyolefin multilayer films. The molds are particularly useful for perishable food applications such as fresh meats or sausages. Thus, th