Claims for Patent: 9,700,486

Summary for Patent: 9,700,486

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, GAMMAGARD LIQUID (an immune globulin infusion (human)); ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method, (rAHF)); BAX 111 (vonicog alfa, or [618-threonine,709-aspartic acid] von Willebrand factor Homo sapiens (1381A>T,1472H>D variant)); or an adeno-associated viral vector containing a liver-specific human factor IX expression cassette, e.g., sscAAV2/8-LP1-hFIXco.
Inventor(s):	Weeks; Wendell P. (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:	14/259,273
Patent Claims:	1. A pharmaceutical product comprising: a pharmaceutical composition comprising an immune globulin infusion; Antihemophilic Factor (Recombinant); recombinant von Willebrand factor (rVWF); or sscAAV2/8-LP1-hFIXco, a self-complementary adeno-associated viral vector containing a liver-specific human factor IX expression cassette, and a pharmaceutically acceptable excipient contained within a glass pharmaceutical container comprising a glass composition comprising: SiO.sub.2 in an amount greater than or equal to about 72 mol. % and less than or equal to about 78 mol. %; alkaline earth oxide comprising both MgO and CaO, wherein CaO is present in an amount up to about 1.0 mol. %, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5; X mol. % Al.sub.2O.sub.3, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %; Y mol. % alkali oxide, wherein the alkali oxide comprises Na.sub.2O in an amount greater than about 8 mol. %; and a ratio of a concentration of B.sub.2O.sub.3 (mol. %) in the glass container to (Y mol. %-X mol. %) is less than or equal to 0.3. 2. The pharmaceutical product of claim 1, wherein the pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa. 3. The pharmaceutical product of claim 1, wherein the pharmaceutical container comprises a compressive stress greater than or equal to 250 MPa. 4. The pharmaceutical product of claim 1, wherein the pharmaceutical container comprises a depth of layer greater than 30 .mu.m. 5. The pharmaceutical product of claim 1, wherein the pharmaceutical product has increased stability, product integrity, or efficacy as compared to the pharmaceutical composition not contained within the glass pharmaceutical container. 6. The pharmaceutical product of claim 1 wherein the glass pharmaceutical container has a compressive stress greater than or equal to 150 MPa and a depth of layer greater than 10 .mu.m, and wherein the pharmaceutical product comprises increased stability, product integrity, or efficacy as compared to the pharmaceutical composition not contained within the glass pharmaceutical container. 7. The pharmaceutical product of claim 1 wherein the glass pharmaceutical container is substantially free of boron, and wherein the pharmaceutical product comprises increased stability, product integrity, or efficacy as compared to the pharmaceutical composition not contained within the glass pharmaceutical container. 8. The pharmaceutical product of claim 7, wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa and a depth of layer greater than 25 .mu.m. 9. The pharmaceutical product of claim 8, wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 300 MPa and a depth of layer greater than 35 .mu.m. 10. The pharmaceutical product of claim 7, wherein said glass pharmaceutical container comprises a substantially homogeneous inner layer. 11. The pharmaceutical product of claim 10, wherein said glass pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa and a depth of layer greater than 25 .mu.m. 12. The pharmaceutical product of claim 1, wherein the pharmaceutical container comprises an internal homogeneous layer.

Details for Patent 9,700,486

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	August 20, 2002		2033-04-24
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	June 07, 2007		2033-04-24
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	July 31, 2009		2033-04-24