Claims for Patent: 10,413,483

Summary for Patent: 10,413,483

Title:	Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
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).
Inventor(s):	Weeks; Wendell Porter (Corning, NY), Schaut; Robert Anthony (Painted Post, NY), DeMartino; Steven Edward (Painted Post, NY), Peanasky; John Stephen (Big Flats, NY)
Assignee:	Corning Incorporated (Corning, NY)
Application Number:	14/966,204
Patent 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 binds to a 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; and wherein the delamination resistant glass container comprises a glass composition having X mol. % Al.sub.2O.sub.3, wherein X is greater than or equal to 2 mol. % and less than or equal to 10 mol. %, Y mol. % alkali oxide, wherein Y is greater than or equal to 8 mol. % and less than or equal to 18 mol. %, the ratio of Y;X is greater than about 0.9 and less than or equal to 2 and a boron content defined by the ratio B.sub.2PO.sub.3/(Y-X) is less than 0.3. 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 .mu.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 .mu.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 .mu.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 .mu.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 .mu.m and an aspect ratio of greater than 50 per trial following accelerated delamination testing.

Details for Patent 10,413,483

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	06/01/1989		2031-10-25
Amgen, Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234			2031-10-25
Amgen, Inc.	PROCRIT	epoetin alfa	Injection	103234			2031-10-25
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2031-10-25