Foil

• US 20060134358A1
• Filed: 11/21/2005
• Published: 06/22/2006
• Est. Priority Date: 06/27/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Nielsen, John Stern, Madsen, Nils Berg
• Granted Patent: US 8,399,078 B2
• Time in Patent Office: Days
• US Class Current: 428/35.200
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B32B 1/00 Layered products having a non-planar shape
• CPC Class Codes: B32B 1/02 Receptacles , i.e. rigid containers, e.g. tanks
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2307/412 Transparent
• CPC Class Codes: B32B 2307/7246 Water vapor barrier
• CPC Class Codes: B32B 2323/04 Polyethylene
• CPC Class Codes: B32B 2323/10 Polypropylene
• CPC Class Codes: B32B 2327/12 containing fluorine
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/28 comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
• CPC Class Codes: B32B 27/304 comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]

Abstract

A container consisting of at least two layers, the inner layer consisting of a PE or PP film and the PCTFE layer consisting of a PCTFE film, and the thickness of the PCTFE layer being about 40-100 μm, which container is equipped with a device where the liquid can be lead out through when desired and which container is transparent, shows superior properties for storing liquid pharmaceutical compositions, especially insulin compositions containing preservatives.

Claims

1. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and the outer layer which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner and outer layers being joined intimately together, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5°

C. for 24 months less than 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight) of the content of water diffuses out from the container; and

when said chamber is filled with water containing about 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of about 5°

C. for 24 months, the change in the concentration of phenol in the liquid is less than about 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight).

3. The container according to claim 1 or 2, wherein the outer layer alone fulfills the requirement that when said chamber is filled with water and when it is stored at a temperature of about 5°

C. for 24 months less than 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight) of the content of water diffuses out from the container.

4. The container according to claim 1, wherein the inner layer alone fulfills the requirement that when said chamber is filled with water containing about 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of about 5°

C. for 24 months, the change in the concentration of phenol in the liquid is less than about 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight);

or when said chamber is filled with water containing about 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of about 37°

C. for 12 weeks, the change in the concentration of phenol in the liquid is less than about 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight).

5. The container according to claim 1, wherein the inner layer is weldable.

9. The container according to claim 1, in which the thickness of the inner layer is above about 10 μ

m, preferably above about 20 μ

m, and below about 60 μ

m, preferably below about 50 μ

m, even more preferred below about 40 μ

m.

10. The container according to claim 1, from which when filled with water and when stored at a temperature of about 5°

C. for 24 months less than 10% (weight/weight), preferably less than 5% (weight/weight), more preferred less than 2% (weight/weight) of the content of water diffuses out from the container.

11. The container according to claim 1, from which when filled with water containing about about 1.8 mg/mL (19 mM) of phenol and when stored at a temperature of about 5°

C. for 24 months, the change in the concentration of phenol is less than about 10% (weight/weight), preferably less than about 5% (weight/weight), more preferred less than about 2% (weight/weight).

12. The container according to claim 1, from which when filled with water containing about 1.8 mg/mL (19 mM) of phenol and when stored at a temperature of about 37°

C. for 12 weeks, the change in the concentration of phenol is less than about 10% (weight/weight), preferably less than about 5% (weight/weight), more preferred less than about 2% (weight/weight).

13. The container according to claim 1, from which when filled with water containing 2.06 mg/mL (19 mM) of m-cresol and when stored at a temperature of about 5°

C. for 24 months, the change in the concentration of m-cresol is less than about 10% (weight/weight), preferably less than about 5% (weight/weight), more preferred less than about 2% (weight/weight).

14. The container according to claim 1, from which when filled with water containing 2.06 mg/mL (19 mM) of m-cresol and when stored at a temperature of about 37°

C. for 12 weeks, the change in the concentration of m-cresol is less than about 10% (weight/weight), preferably less than about 5% (weight/weight), more preferred less than about 2% (weight/weight).

15. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test A gives a maximum loss of m-cresol of about 10% (weight/weight), preferably not more than about 5% (weight/weight).

16. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test A gives a change in the pH value which is than about +/−

0.2.

17. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test B gives a maximum weight loss of about 2.5% (weight/weight), preferably not more than about 1% (weight/weight).

18. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test B gives a maximum loss of m-cresol of about 10% (weight/weight), preferably not more than about 5% (weight/weight).

19. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test B gives a change in the pH value which is more than about +/−

0.2.

20. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test C gives a maximum weight loss of 2.5% (weight/weight), preferably not more than about 2% (weight/weight).

21. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test C gives a maximum loss of m-cresol of about 10% (weight/weight), preferably not more than about 5% (weight/weight).

22. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test C gives a maximum loss of phenol of about 10% (weight/weight), preferably not more than about 5% (weight/weight).

23. The container according to claim 1, which is prepared from a pouch foil which when tested by the above test C gives a change in the pH value which is not more than about +/−

0.2.

24. The container according to claim 1, which is prepared from a pouch foil which fulfills the above test D for the dilution 1:

50, preferably the dilution 1;

100, more preferred the dilution 1;

200, even more preferred the dilution 1;

400.

25. The container according to claim 1, in which the thickness of the tie layer or tie layers in the foil is in the range from about 1 μ

m to about 10 μ

m, preferably below about 8 μ

m, more preferred below about 6 μ

m.

26. The container according to claim 1, which is flexible.

27. The container according to claim 1, which container is equipped with a device whereby said liquid can be expelled from said container.

28. The container according to claim 1, wherein a third polymeric layer is added on the outer side of the PCTFE layer.

29. The container according to claim 1, which container, when completely filled with liquid, can contain an amount of liquid which is at least about 0.5 ml, preferably at least about 1 ml, and not more than about 10 ml, preferably not more than about 5 ml, more preferred not more than about 2 ml and, preferably, the volume is about 1.5 ml.

30. The container according to claim 1 but the last one, which container, when completely filled with liquid, can contain an amount of liquid which is from about 2 ml to about 4 ml, preferably about 3 ml.

31. A use of a container according to any one of the above claims for storing a liquid pharmaceutical composition mentioned in any of the preceding claims.

32. A container according to claim 1 filled partially or wholly with a liquid pharmaceutical composition.

33. A container according to claim 32 wherein at least 95% (volume/volume), preferably at least 98% (volume/volume), more preferred at least 99% (volume/volume), and even more preferred at least 99.9% (volume/volume), of the inner of the container contains the liquid pharmaceutical composition

34. The container according to claim 1 filled partially or wholly with a liquid pharmaceutical composition wherein the active ingredient is a peptide.

35. The container according to the claim 34 wherein the peptide is insulin.

36. The container according to claim 35 wherein the content of insulin is in the range from about 10 U/ml to about 1500 U/ml.

37. The container according to claim 1 containing a preservative.

38. A container according to claim 1 filled partially or wholly with a liquid pharmaceutical composition containing phenol.

39. A container according to claim 1 filled partially or wholly with a liquid pharmaceutical composition containing m-cresol.

40. A container according to claim 1 filled with a liquid pharmaceutical composition containing benzyl alcohol.

41. A film material comprising at least two layers, said layers being joined intimately together, characterized in that the film material can be used for preparing a transparent container according to any one of the above claims.

2. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and the outer layer which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner and outer layers being joined intimately together, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5°

C. for 24 months less than 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weigh/weight) of the content of water diffuses out from the container; and

when said chamber is filled with water containing about 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of about 37°

C. for 12 weeks, the change in the concentration of phenol in the liquid is less than about 10% (weight/weight), preferably less than 5% (weight/weight), even more preferred less than 3% (weight/weight).

6. A container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and another layer consisting of a PCTFE film which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner layer consisting of a PE or PP film, and either said inner layer and said PCTFE layer being a coextrudate or an extrusion-laminate or said inner layer and said PCTFE layer being joined together, and the thickness of said PCTFE layer being above about 40 μ

m, and being below about 100 μ

m, preferably below about 75 μ

m.

7. The container according to claim 6, which is at least partially transparent.

8. The container according to claim 7, which is wholly transparent.