Foil

• US 8,399,078 B2
• Filed: 11/21/2005
• Issued: 03/19/2013
• Est. Priority Date: 06/27/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Madsen, Nils Berg, Nielsen, John Stern
• Primary Examiner(s): Kashnikow, Erik
• Application Number:
  US11/283,653
• Publication Number:
  US 20060134358A1
• Time in Patent Office: 2,675 Days
• Field of Search: 428/35.2, 428/35.7, 428/36.92, 62/60, 644/579, 206/438, 206/570, 206/828, 383/110, 383/113, 604/403, 604/408, 604/410
• US Class Current: 428/35.7
• 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 1/08 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 pharmaceutical composition in a water-tight chamber, the container comprising:

a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol;

a flexible wall material, that forms the water-tight chamber, comprising at least two layers, an inner layer consisting of polyethylene (PE) or polypropylene (PP) in intimate contact with said liquid pharmaceutical composition, and an outer layer consisting of polychlorotrifluoroethylene (PCTFE), said inner and outer layers being joined intimately together by a tie layer,

wherein when said chamber is filled with water and stored at a temperature of about 5°

C. for 24 months, 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 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),

wherein the outer layer alone fulfills the requirement that when said chamber is filled with water and stored at a temperature of about 5°

C. for 24 months less than 10% (weight/weight) of the content of water diffuses out from the container.

2. The container according to claim 1, 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 5% (weight/weight) of the content of water diffuses out from the container.

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

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

m and about 60 μ

m.

5. The container according to claim 1 wherein the thickness of the tie layer is in the range from about 1 μ

m to about 10 μ

m.

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

7. The container according to claim 1, wherein the liquid-tight chamber has a volume of at least about 0.5 ml and not more than about 10 ml.

8. The container according to claim 7 wherein the volume is from about 2 ml to about 4 ml.

9. A container according to claim 1, wherein at least 95% (volume/volume) of the water-tight chamber contains the liquid pharmaceutical composition.

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

11. The container according to claim 10, wherein the peptide is insulin.

12. The container according to claim 11 wherein the content of insulin is in the range from about 10 U/ml to about 1500 U/ml.

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

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

15. A container according to claim 1 filled with a liquid pharmaceutical composition comprising benzyl alcohol.

16. A flexible, at least partially transparent container for storage of a liquid pharmaceutical composition in a water-tight chamber, the container comprising:

a liquid pharmaceutical composition comprising, an active ingredient and at least one preservative selected from the group consisting of phenol, m-cresol, and benzyl alcohol; and

a wall material that forms the water-tight chamber, comprising at least two layers, an inner layer consisting of a polyethylene (PE) or polypropylene (PP) film layer which is in intimate contact with said liquid pharmaceutical composition, and another layer consisting of a polychlorotrifluoroethylene (PCTFE) film layer, said two layers in direct contact by a tie layer, and either said inner layer and said PCTFE layer being a coextrudate or an extrusion-laminate, and the thickness of said PCTFE layer being between about 40 μ

m and about 100 μ

m.

17. The container according to claim 16, which is wholly transparent.

18. The container according to claim 16, wherein a third polymeric layer is added on the outer side of the PCTFE layer.