DELAMINATION RESISTANT PHARMACEUTICAL GLASS CONTAINERS CONTAINING ACTIVE PHARMACEUTICAL INGREDIENTS

• US 20160095796A1
• Filed: 12/11/2015
• Published: 04/07/2016
• Est. Priority Date: 10/25/2011
• Status: Active Grant

• Current Assignee: Corning Incorporated
• Original Assignee: Corning Incorporated
• Inventors: Weeks, Wendell P., Schaut, Robert Anthony, DeMartino, Steven Edward, Peanasky, John Stephen
• Granted Patent: US 10,413,483 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61K 31/403 condensed with carbocyclic rings, e.g. carbazole
• CPC Class Codes: A61K 38/17 from animals; from humans enzyme inhibitors A61K38/005
• CPC Class Codes: A61K 38/1816 Erythropoietin [EPO]
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: C03C 21/002 to perform ion-exchange between alkali ions C03C21/005 takes precedence
• CPC Class Codes: C03C 3/087 containing calcium oxide, e.g. common sheet or container glass
• CPC Class Codes: C03C 3/091 containing aluminium
• CPC Class Codes: C03C 4/20 for chemical resistant glass
• CPC Class Codes: C07K 16/241 Tumor Necrosis Factors
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
• CPC Class Codes: Y10T 428/131 Glass, ceramic, or sintered, fused, fired, or calcined metal oxide or metal carbide containing [e.g., porcelain, brick, cement, etc.]

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, PROCRIT (epoetin alfa), REMICADE (Infliximab) or DORIBAX (doripenem).

Claims

1. A pharmaceutical composition comprising:

an active pharmaceutical ingredient selected from the group consisting of epoetin alfa, doripenem monohydrate, infliximab, an erythropoiesis-stimulating glycoprotein, and an antibody specific for human necrosis factor alpha; and

a pharmaceutically acceptable excipient;

wherein the pharmaceutical composition is contained within a delamination resistant glass container such that the pharmaceutical composition has increased stability, product integrity, or efficacy.

2. The pharmaceutical composition of claim 1, wherein the delamination resistant glass container comprises an internal homogeneous layer.

3. The pharmaceutical composition of claim 1, wherein the delamination resistant glass container comprises a compressive stress greater than or equal to 250 MPa.

4. The pharmaceutical composition of claim 3, wherein the delamination resistant glass container comprises a depth of layer greater than 30 μ

m.

5. The pharmaceutical composition of claim 4, wherein the delamination resistant glass container is free of boron and compounds of boron.

6. The pharmaceutical composition of claim 1, wherein the delamination resistant glass container comprises, on average, less than 3 glass particles with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

7. The pharmaceutical composition of claim 1, wherein the delamination resistant glass container is a delamination-stable glass container.

8. The pharmaceutical composition of claim 7, wherein the delamination-stable glass container comprises, on average, less than 2 glass particles with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

9. The pharmaceutical composition of claim 1, wherein the delamination resistant glass container is a delamination-proof glass container.

10. The pharmaceutical composition of claim 9, wherein the delamination-proof glass container comprises, on average, less than 1 glass particle with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

11. The pharmaceutical composition of claim 1, wherein the delamination resistant glass container is a delamination-free glass container.

12. The pharmaceutical composition of claim 11, wherein the delamination-free glass container comprises 0 glass particles with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

13. A method of enhancing the stability, product integrity, or efficacy of a pharmaceutical composition comprising an active pharmaceutical ingredient selected from the group consisting of epoetin alfa, doripenem monohydrate, infliximab, an erythropoiesis-stimulating glycoprotein, and an antibody specific for human necrosis factor alpha, wherein the method comprises containing the pharmaceutical composition in a delamination resistant glass container.

14. The method of claim 13, wherein the delamination resistant glass container comprises an internal homogeneous layer and a compressive stress greater than 150 MP.

15. The method of claim 13, wherein the delamination resistant glass container comprises, on average, less than 3 glass particles with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

16. The method of claim 13, wherein the delamination resistant glass container is a delamination-stable glass container.

17. The method of claim 16, wherein the delamination-stable glass container comprises, on average, less than 2 glass particles with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

18. The method of claim 13, wherein the delamination resistant glass container is a delamination-proof glass container.

19. The method of claim 18, wherein the delamination-proof glass container comprises, on average, less than 1 glass particle with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

20. The method of claim 13, wherein the delamination resistant glass container is a delamination-free glass container.

21. The method of claim 20, wherein the delamination-free glass container comprises 0 glass particles with a minimum width of 50 μ

m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.