Desiccating container for moisture-sensitive material

• US 5,947,274 A
• Filed: 02/20/1997
• Issued: 09/07/1999
• Est. Priority Date: 08/05/1994
• Status: Expired due to Term

• Current Assignee: West Pharmaceutical Services Cornwall Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: Smithkline Beecham PLC (GSK plc)
• Inventors: Holland, Simon Joseph, Taskis, Charles Bernard, Whatmore, Paul John
• Primary Examiner(s): Gehman, Bryon P.
• Application Number:
  US08/776,807
• Time in Patent Office: 929 Days
• Field of Search: 206/204, 215/227, 215/228, 215/231, 215/247-249, 215/364, 312/31.1
• US Class Current: 206/204
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
• CPC Class Codes: B65D 51/30 for desiccators
• CPC Class Codes: B65D 81/266 for absorbing gases, e.g. oxygen absorbers or desiccants B65D51/244, B65D51/30 take precedence

Abstract

The present invention is to a container, particularly for moisture sensitive materials, having a container body of a substantially atmospheric moisture-impermeable material and incorporating a solid element which is made at least in part of a desiccating polymer and which is in contact with the atmosphere inside the container.

Claims

1. A container having within it contents comprising a moisture sensitive material and an atmosphere, the container comprising a container body of a substantially atmospheric moisture-impermeable material and having an opening sealed by a closure, the closure having an inner face exposed to said contents, at least a part of said closure being made of a desiccating polymer and forming at least a part of said inner face, the desiccatitng polymer being an elastomeric material compounded with a filler, the elastoneric material further including a sufficient quantity of a desiccating material to absorb enough moisture from said contents of the container to reduce degradation of the moisture sensitive material by water and water vapour, the closure also comprising a closure wall having a puncturable region therein in direct communication with the interior of the container.

2. A container according to claim 1 which is a vial.

3. A container according to claim 2 which vial is glass.

4. A container according to claim 3 which vial contains potassium clavulanate and sodium amoxycillin.

5. A container according to claim 4 wherein the desiccating polymer is able to take up atmospheric moisture at 30% RH or less.

6. A container according to claim 4 wherein the sodium amoxycillin is crystalline sodium amoxycillin.

7. A container according to claim 1 in which the elastomeric material is selected from the group consisting of a halobutyl and silicone rubber.

8. A container according to claim 7 wherein the elastomeric material further contains a reinforcing filler, and wherein the desiccating material replaces from about 10 to about 50% of the weight of the filler.

9. A container according to claim 8 wherein the desiccating material replaces from about 20 to about about 40% of the filler.

10. A container according to claim 8 wherein the desiccating material replaces from about 40 to about 50% of the filler.

11. A container according to claim 1 in which the desiccating material is an inorganic desiccating material.

12. A container according to claim 11 in which the desiccating material chemically absorbs water.

13. A container according to claim 11 in which the desiccating material chemically fixes water.

14. A container according to claim 11 in which the desiccating material physiochemically absorbs water.

15. A container according to claim 11 in which the desiccating material is selected from the group consisting of a dried molecular sieve, calcium oxide, and mixtures thereof.

16. A container according to claim 11 or 15 in which the elastomeric material is chlorobutyl rubber.

17. A container according to claim 1 in which the desiccating polymer is able to take up atmospheric moisture at 30% RH or less.

18. A container according to claim 1 in which part of the closure which engages the opening is at least partly made of an elastomeric material thereby allowing a tight compression fit with the mouth of the container.

19. A container according to claim 1 in which the closure is of multi-part construction.

20. A container according to claim 1 wherein the closure is made only of the desiccating polymer.

21. A container according to claim 1 in which the quantity of desiccating material in the desiccating polymer is sufficient to prevent degradation of the moisture senstitive material by water and water vapor.

22. A container according to claim 1 in which said desiccating polymer forms a part of the closure and is exposed only to the interior of the closure.

23. A container according to claim 1 in which said desiccating polymer forms a part of the closure and is separated from the external atmosphere by a part of the closure which does not include desiccating polymer.

24. A container according to claim 1 in which said desiccating polymer constitutes from about 10% to about 50% of the weight of the filler.

28. A method of desiccating lyophilised, freeze dried material which comprises, as a final dehydrating step, placing the material in a container as defined in claim 1, in the form of a vial, and having a closure made of a desiccating polymer formed from an elastomeric material compounded with a desiccating material, sealing said vial, so that the dehydration process is completed in the sealed vial.

25. A container for a moisture sensitive material in the form of a vial, having a container body of glass and having an opening sealed by a closure which closure is wholly made of halobutyl rubber compounded with a filler and a desiccating material selected from the group consisting of molecular sieve, calcium oxide, and mixtures thereof, and wherein the desiccating material replaces from about 10 to 50% of the weight of the filler, the closure comprising a closure wall having a puncturable region therein in direct communication with the interior of the container.

26. A container according to claim 25 wherein the desiccating material replaces from about 40 to about 50% of the filler.

27. A method of desiccating potassium clavulanate in combination with crystalline sodium amoxycillin which comprises enclosing potassium clavulanate in combination with crystalline sodium amoxycillin in a container with a closure, the closure comprising a dessicatintg polymer and maintaining the desiccating polymer in contact with the atmosphere inside said container, the desiccating polymner being an elastomeric material compounded with a desiccating material which material provides the dessicating activity in said container.

29. A closure for a vial, containing a mouth opening, which closure is formed from an elastomeric material compounded with a filler and a desiccating material, and wherein the desiccating material replaces from about 10 to 50% of the weight of the filler, the closure comprising a closure wall having a puncturable region therein in direct communication with the interior of the vial.

30. A closure according to claim 29 in which the elastomeric material is selected from the group consisting of halobutyl and silicone rubber.

31. A closure according to claim 29 in which the desiccating material is an inorganic desiccating material.

32. A closure according to claim 31 in which the desiccating material chemically absorbs water.

33. A closure according to claim 31 in which the desiccating material chemically fixes water.

34. A closure according to claim 31 in which the desiccating material physiochemically absorbs water.

35. A closure according to claim 31 in which the desiccating material is selected from the group consisting of a dried molecular sieve, calcium oxide, and mixtures thereof.

36. A closure according to claim 30 or 35 in which the elastomeric material is chlorobutyl rubber.

37. A closure according to claim 29 in which part of the closure which engages the mouth opening is at least partly made of an elastomeric material thereby allowing a tight compression fit with the mouth opening of the container.

38. A closure according to claim 29 which is of multi-part construction.

39. A closure according to claim 37 or 38 in which the closure is made wholly of the desiccating polymer.

40. A closure according to claim 29 wherein the desiccating material replaces from about 40 to about 50% of the filler.

41. A closure according to claim 29 in which the elastomeric material is a halobutyl rubber.

42. A closure according to claim 29 in which the desiccating material is selected from the group consisting of molecular sieve, calcium oxide, and mixtures thereof.

43. A closure according to claim 29 in which the filler comprises a china clay.