Claims for Patent: 9,839,579

Summary for Patent: 9,839,579

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, Victoza (liraglutide), Tresiba (insulin degludec), Ryzodeg (insulin degludec/insulin aspart), IDegLira (liraglutide and insulin degludec), NovoSeven (recombinant human coagulation factor VIIa), NovoSeven RT (recombinant human coagulation factor VIIa), or Turoctocog alfa (third-generation recombinant coagulation factor VIII).
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:	14/259,277
Patent Claims:	1. A pharmaceutical product comprising: a pharmaceutical composition comprising: liraglutide, insulin degludec, insulin degludec/insulin aspart, liraglutide and insulin degludec, recombinant human coagulation factor VIIa, recombinant human coagulation factor VIIa, or third-generation recombinant coagulation factor VIII; and a pharmaceutically acceptable excipient; wherein the pharmaceutical composition is contained within a glass pharmaceutical container comprising a glass composition comprising: SiO.sub.2 in a an amount greater than or equal to 72 mol. % and less than or equal to 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. %)+Mg0 (mol. %))) is less than or equal to 0.5; X mol. % Al.sub.2O.sub.3, wherein X is greater than or equal to 5 mol. % and less than or equal to 7 mol. %; Y mol. % alkali oxide, wherein the alkali oxide comprises Na.sub.2O in an amount greater than 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 glass pharmaceutical container maintains the stability, product integrity, or efficacy of the pharmaceutical composition. 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 glass pharmaceutical container maintains the stability, product integrity, or efficacy of the pharmaceutical composition. 7. The pharmaceutical product of claim 1: wherein the glass pharmaceutical container is substantially free of boron, and wherein the glass pharmaceutical container maintains the stability, product integrity, or efficacy of the pharmaceutical composition. 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 an internal homogeneous 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 9,839,579

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	06/07/2000		2033-04-24
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	01/19/2001		2033-04-24
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	04/23/2004		2033-04-24
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	10/31/2013		2033-04-24
Novo Nordisk Inc.	NOVOSEVEN, NOVOSEVEN RT	coagulation factor viia (recombinant)	For Injection	103665	03/25/1999		2033-04-24