Transparent, flexible, impermeable plastic container for storage of pharmaceutical liquids

• US 20070014951A1
• Filed: 06/22/2006
• Published: 01/18/2007
• Est. Priority Date: 12/22/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Soerensen, Anne, Sparholt, Philip, Hansen, Marianne
• Granted Patent: US 7,807,242 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: B32B 2307/412 Transparent
• CPC Class Codes: B32B 2307/7265 Non-permeable
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/30 comprising vinyl (co)polymers; comprising acrylic (co)polymers
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/322 comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: C08J 2323/02 not modified by chemical after treatment
• CPC Class Codes: C08J 5/18 Manufacture of films or sheets
• CPC Class Codes: Y10S 206/828 Medicinal content
• 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 a PCTFE monolayer, the thickness of said 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 (6) of which chamber (5) comprises a PCTFE monolayer, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5°

C. for 2 years less than 10% (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%.

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

29. A use of a container according to claim 28 for storing a liquid pharmaceutical composition mentioned in any of the preceding claims.

30. A container according to claim 29 filled partially or wholly with a liquid pharmaceutical composition.

31. A container according to claim 30 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.

32. The container according to claim 31 filled partially or wholly with a liquid pharmaceutical composition wherein the active ingredient is a peptide.

33. The container according to claim 32 wherein the peptide is insulin.

34. The container according to claim 33 wherein the content of insulin is in the range from about 10 U/ml to about 1500 U/ml.

35. The container according to claim 34 containing a preservative.

36. A container according to claim 35 filled partially or wholly with a liquid pharmaceutical composition containing phenol.

37. A container according to claim 36 filled partially or wholly with a liquid pharmaceutical composition containing m-cresol.

38. A container according to claim 37 filled partially or wholly with a liquid pharmaceutical composition containing benzyl alcohol.

39. A PCTFE film, characterized in that the film material can be used for preparing a transparent container according to claim 38.

2. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material (6) of which chamber (5) comprises a PCTFE monolayer, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5°

C. for 2 years less than 10% (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 37°

C. for 12 weeks, the change in the concentration of phenol in the liquid is less than about 10%.

3. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material (6) of which chamber (5) comprises a PCTFE monolayer, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5°

C. for 2 years less than 10% (weight/weight) of the content of water diffuses out from the container; and

when said chamber is 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%.

4. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material (6) of which chamber (5) comprises a PCTFE monolayer, characterized in that when said chamber is filled with water and when it is stored at a temperature of about 5°

C. for 2 years less than 10% (weighttweight) of the content of water diffuses out from the container; and

when said chamber is 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-resol is less than about 10%.

5. A flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material (6) of which chamber (5) comprises a PCTFE monolayer, characterized in that the thickness of the wall material being above about 40 μ

m, and being below about 100 μ

m, preferably below about 75 μ

m.

7. A container for storage of a liquid in a water-tight chamber, the thickness of the wall material being above about 40 μ

m, and being below about 100 μ

m, preferably below about 75 μ

m.

8. The container according to claim 7 wherein the container is at least partially transparent.

9. The container according to claim 8 wherein the container is wholly transparent.

10. The container according to claim 9, from which when filled with water and when stored at a temperature of about 5°

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

11. The container according to claim 10, from which when filled with water containing 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% preferably less than about 5%, more preferred less than about 2%.

12. The container according to claim 11, 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%, preferably less than about 5%, more preferred less than about 2%.

13. The container according to claim 12, 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%, preferably less than about 5%, more preferred less than about 2%.

14. The container according to claim 13, 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%, preferably less than about 5%, more preferred less than about 2%.

15. The container according to claim 14, which is prepared from a pouch foil which when tested by test A described herein gives a maximum loss of m-cresol of about 10%, preferably not more than about 5%.

16. The container according to claim 15, which is prepared from a pouch foil which when tested by test A described herein gives a change in the pH value which is than about ±

0.2.

17. The container according to claim 16, which is prepared from a pouch foil which when tested by test B described herein gives a maximum weight loss of about 2.5%, preferably not more than about 1%.

18. The container according to claim 17, which is prepared from a pouch foil which when tested by test B described herein gives a maximum loss of m-cresol of about 10%, preferably not more than about 5%.

19. The container according to claim 18, which is prepared from a pouch foil which when tested by test B described herein gives a change in the pH value which is more than about ±

0.2.

20. The container according to claim 19, which is prepared from a pouch foil which when tested by test C described herein gives a maximum weight loss of 2.5%, preferably not more than about 2%.

21. The container according to claim 20, which is prepared from a pouch foil which when tested by test C described herein gives a maximum loss of m-cresol of about 10%, preferably not more than about 5%.

22. The container according to claim 21 which is prepared from a pouch foil which when tested by test C described herein gives a maximum loss of phenol of about 10%, preferably not more than about 5%.

23. The container according to claim 22, which is prepared from a pouch foil which when tested by test C described herein gives a change in the pH value which is not more than about ±

0.2.

24. The container according to acclaim 23, which is prepared from a pouch foil which fulfills test D described herein 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 24, which is flexible.

26. The container according to claim 25, which container is equipped with a device whereby said liquid can be expelled from said container.

27. The container according to claim 26, wherein a second polymeric layer is added on a part of the outer side of the PCTFE layer or on the whole side thereof.

28. The container according to claim 27, 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 3 ml and, preferably, the volume is about 2.5 ml.