IP Library › Granted Patent US 9,186,295
Granted Patent B2
US 9,186,295 · App. 13/660,712 · Granted Nov 17, 2015

Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients

Inventors: Wendell Porter Weeks (Corning, NY); Robert Anthony Schaut (Painted Post, NY); Steven Edward DeMartino (Painted Post, NY); John Stephen Peanasky (Big Flats, NY)
Assignee: Corning Incorporated
A61J1/00A61K39/3955C03C3/087C03C3/091C03C4/20C03C21/002Y10T428/131
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Quick Facts
Patent No.
US 9,186,295
App. No.
13/660,712
Granted
Nov 17, 2015
Kind
B2
Abstract

The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, LANTUS (insulin glargine [rDNA]), LOVENOX (Enoxaparin), PENTACT-HIB ( Hemophilus influenzae type b polysaccharide conjugated to tetanus protein, diphtheria, tetanus, pertussis and inactivated poliovirus vaccines) or FLUZONE or VAXIGRIP (influenza virus vaccine).

Claims (60)

1. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising:

SiO 2 in a concentration greater than about 74 mol. %;

alkaline earth oxide comprising MgO and CaO, wherein CaO is present in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. % relative to the glass composition, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5; and

Y mol. % alkali oxide, wherein the alkali oxide comprises Na 2 O in an amount greater than about 8 mol. %, wherein the glass composition is free of boron and compounds of boron, and

wherein the pharmaceutical composition comprises one of insulin glargine [rDNA], enoxaparin, a vaccine, an influenza virus vaccine or PENTAct-HIB.

2. The pharmaceutical container of claim 1 , wherein the pharmaceutical composition comprises a citrate or phosphate buffer.

3. The pharmaceutical container of claim 2 , wherein the buffer is selected from the group consisting of sodium citrate, SSC, monosodium phosphate and disodium phosphate.

4. The pharmaceutical container of claim 1 , wherein the pharmaceutical composition has a pH between about 7 and about 11.

5. The pharmaceutical container of claim 1 , wherein the pharmaceutical composition comprises insulin glargine rDNA.

6. The pharmaceutical container of claim 1 , wherein the pharmaceutical composition comprises enoxaparin.

7. The pharmaceutical container of claim 1 , wherein the pharmaceutical composition comprises a vaccine.

8. The pharmaceutical container of claim 7 , wherein the vaccine is an influenza virus vaccine.

9. The pharmaceutical container of claim 1 , wherein the vaccine is PENTAct-HIB.

10. The pharmaceutical container of claim 1 , wherein the concentration of SiO 2 is less than or equal to about 80 mol. %.

11. The pharmaceutical container of claim 1 , wherein the glass composition is free from phosphorous and compounds of phosphorous.

12. The pharmaceutical container of claim 1 , further comprising X mol. % Al 2 O 3 , wherein a ratio of Y:X is greater than 1.

13. The pharmaceutical container of claim 12 , wherein the ratio of Y:X is less than or equal to 2.

14. The pharmaceutical container of claim 12 , wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %.

15. The pharmaceutical container of claim 12 , wherein the alkaline earth oxide is present in an amount from about 3 mol. % to about 13 mol. %.

16. The pharmaceutical container of claim 12 , wherein the ratio of Y:X is greater than or equal to 1.3 and less than or equal to 2.

17. The pharmaceutical container of claim 12 , wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %.

18. The pharmaceutical container of claim 1 , wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.3.

19. The pharmaceutical container of claim 1 , further comprising SnO 2 .

20. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising:

from about 74 mol. % to about 78 mol. % SiO 2 ;

from about 4 mol. % to about 8 mol. % alkaline earth oxide, wherein the alkaline earth oxide comprises both MgO and CaO and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5;

X mol. % Al 2 O 3 , wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %; and

Y mol. % alkali oxide, wherein the alkali oxide comprises Na 2 O in an amount greater than or equal to about 9 mol. % and less than or equal to about 15 mol. %, a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, and

wherein the pharmaceutical composition comprises one of insulin glargine [rDNA], enoxaparin, a vaccine, an influenza virus vaccine or PENTAct-HIB.

21. The pharmaceutical container of claim 20 , wherein the ratio of Y:X is less than or equal to about 2.

22. The pharmaceutical container of claim 20 , wherein the ratio of Y:X is greater than or equal to about 1.3 and less than or equal to about 2.0.

23. The pharmaceutical container of claim 20 , wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1.

24. The pharmaceutical container of claim 20 , wherein the alkaline earth oxide comprises from about 3 mol. % to about 7 mol. % MgO.

25. The pharmaceutical container of claim 20 , wherein the alkaline earth oxide comprises CaO in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. %.

26. The pharmaceutical container of claim 20 , wherein the alkali oxide further comprises K 2 O in an amount greater than or equal to about 0.01 mol. % and less than or equal to about 1.0 mol. %.

27. The pharmaceutical container of claim 20 , wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %.

28. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising:

from about 74 mol. % to about 78 mol. % SiO 2 ;

alkaline earth oxide comprising both CaO and MgO, wherein the alkaline earth oxide comprises CaO in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. % relative to the glass composition, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5;

X mol. % Al 2 O 3 , wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %; and

Y mol. % alkali oxide, wherein the alkali oxide comprises from about 0.01 mol. % to about 1.0 mol. % K 2 O and a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, and

wherein the pharmaceutical composition comprises one of insulin glargine [rDNA], enoxaparin, a vaccine, an influenza virus vaccine or PENTAct-HIB.

29. The pharmaceutical container of claim 28 , wherein the ratio of Y:X is less than or equal to 2.

30. The pharmaceutical container of claim 28 , wherein the ratio of Y:X is greater than or equal to 1.3 and less than or equal to 2.0.

31. The pharmaceutical container of claim 28 , wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1.

32. The pharmaceutical container of claim 28 , wherein the glass composition is free of phosphorous and compounds of phosphorous.

33. The pharmaceutical container of claim 28 , wherein the alkali oxide further comprises Na 2 O in an amount greater than about 8 mol. %.

34. The pharmaceutical container of claim 28 , wherein the alkali oxide further comprises Na 2 O in an amount greater than or equal to about 2 mol. % and less than or equal to about 15 mol. %.

35. The pharmaceutical container of claim 28 , wherein the alkali oxide further comprises from about 9 mol. % to about 13 mol. % Na 2 O.

36. The pharmaceutical container of claim 28 , wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %.

37. The pharmaceutical container of claim 20 , wherein the pharmaceutical composition comprises insulin glargine [rDNA].

38. The pharmaceutical container of claim 20 , wherein the pharmaceutical composition comprises enoxaparin.

39. The pharmaceutical container of claim 20 , wherein the pharmaceutical composition comprises a vaccine.

40. The pharmaceutical container of claim 20 , wherein the pharmaceutical composition comprises an influenza virus vaccine.

41. The pharmaceutical container of claim 20 , wherein the pharmaceutical composition comprises PENTAct-HIB.

42. The pharmaceutical container of claim 28 , wherein the pharmaceutical composition comprises insulin glargine [rDNA].

43. The pharmaceutical container of claim 28 , wherein the pharmaceutical composition comprises enoxaparin.

44. The pharmaceutical container of claim 28 , wherein the pharmaceutical composition comprises a vaccine.

45. The pharmaceutical container of claim 28 , wherein the pharmaceutical composition comprises an influenza virus vaccine.

46. The pharmaceutical container of claim 28 , wherein the pharmaceutical composition comprises PENTAct-HIB.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2013
From: DEMARTINO, STEVEN EDWARD; PEANASKY, JOHN STEPHEN; SCHAUT, ROBERT ANTHONY; WEEKS, WENDELL PORTER
To: CORNING INCORPORATED
Reel/Frame 029902/0425 →
Continuity (3)
Provisional Application 61551163 · Oct 25, 2011
Provisional Application 61656998 · Jun 7, 2012
Related Publication 20130196097A1 · Aug 1, 2013