Claims for Patent: 9,849,066

Summary for Patent: 9,849,066

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, PEDIARIX.RTM. (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine), HAVRIX.RTM. (Hepatitis A Vaccine), ENGERIX-B.RTM. (Hepatitis B Vaccine (Recombinant)), TWINRIX.RTM. (Hepatitis A & Hepatitis B (Recombinant) Vaccine), EPERZAN.RTM. (albiglutide), MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (astuprotimut-R), GSK2402968 (drisapersen), and HZ/su (herpes zoster vaccine).
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:	14/259,281
Patent Claims:	1. A packaged pharmaceutical composition comprising: A glass pharmaceutical container and a pharmaceutical composition contained within the glass pharmaceutical container, wherein the pharmaceutical composition comprises: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine, Hepatitis A Vaccine, Hepatitis B Vaccine (Recombinant), Hepatitis A & Hepatitis B (Recombinant) Vaccine, albiglutide, MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (astuprotimut-R), GSK2402968 (drisapersen), or HZ/su (herpes zoster vaccine) and a pharmaceutically acceptable excipient; wherein the glass pharmaceutical container comprises 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. %)+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 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 packaged pharmaceutical composition of claim 1, wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 150 MPa. 3. The packaged pharmaceutical composition of claim 1, wherein the glass pharmaceutical container comprises a compressive stress greater than or equal to 250 MPa. 4. The packaged pharmaceutical composition of claim 1, wherein the glass pharmaceutical container comprises a depth of layer greater than 30 .mu.m. 5. The packaged pharmaceutical composition of claim 1, wherein the glass pharmaceutical container maintains the stability, product integrity, or efficacy of the pharmaceutical composition. 6. The packaged pharmaceutical composition 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 packaged pharmaceutical composition 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 packaged pharmaceutical composition 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 packaged pharmaceutical composition 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 packaged pharmaceutical composition of claim 7, wherein said glass pharmaceutical container comprises an internal homogeneous layer. 11. The packaged pharmaceutical composition 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 packaged pharmaceutical composition of claim 1, wherein the glass pharmaceutical container comprises an internal homogeneous layer.

Details for Patent 9,849,066

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	07/23/1986		2039-02-26
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239	08/28/1989		2039-02-26
Glaxosmithkline Biologicals	HAVRIX	hepatitis a vaccine inactivated	Injection	103475	02/22/1995		2039-02-26
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431	04/15/2014		2039-02-26