Claims for Patent: 9,198,829

Summary for Patent: 9,198,829

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, NEUPOGEN.RTM. (filgrastim), NEULASTA.RTM. (pegfilgrastim), (epoetin alfa) or ENBREL.RTM. (etanercept).
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:	13/660,690
Patent Claims:	1. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising: SiO.sub.2 in a concentration greater than about 74 mol. %; alkaline earth oxide comprising MgO and CaO, wherein CaO is present in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. % relative to the glass composition, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5; and Y mol. % alkali oxide, wherein the alkali oxide comprises Na.sub.2O in an amount greater than about 8 mol. %, wherein the glass composition is free of boron and compounds of boron, and wherein the pharmaceutical composition comprises one of Filgrastim, Pegfilgrastim, epoetin alfa, etanercept, recombinant human granulocyte-colony stimulating factor or an analog thereof, PEGylated recombinant human granulocyte-colony stimulating factor or an analog thereof, an erythropoiesis-stimulating glycoprotein, or a fusion protein of TNF Receptor 2 and IgG1. 2. The pharmaceutical container of claim 1, wherein the pharmaceutical composition comprises a citrate or phosphate buffer. 3. The pharmaceutical container of claim 2, wherein the buffer is selected from the group consisting of sodium citrate, SSC, monosodium phosphate and disodium phosphate. 4. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is a solution having a pH between about 7 and about 11. 5. The pharmaceutical container of claim 1, wherein the concentration of SiO.sub.2 is less than or equal to about 80 mol. %. 6. The pharmaceutical container of claim 1, wherein the glass composition is free from phosphorous and compounds of phosphorous. 7. The pharmaceutical container of claim 1, further comprising X mol. % Al.sub.2O.sub.3, wherein a ratio of Y:X is greater than 1. 8. The pharmaceutical container of claim 7, wherein the ratio of Y:X is less than or equal to 2. 9. The pharmaceutical container of claim 7, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %. 10. The pharmaceutical container of claim 7, wherein the alkaline earth oxide is present in an amount from about 3 mol. % to about 13 mol. %. 11. The pharmaceutical container of claim 7, wherein the ratio of Y:X is greater than or equal to 1.3 and less than or equal to 2. 12. The pharmaceutical container of claim 7, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %. 13. The pharmaceutical container of claim 1, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.3. 14. The pharmaceutical container of claim 1, further comprising SnO.sub.2. 15. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising: from about 74 mol. % to about 78 mol. % SiO.sub.2; from about 4 mol. % to about 8 mol. % alkaline earth oxide, wherein the alkaline earth oxide comprises both MgO and CaO 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 2 mol. % and less than or equal to about 10 mol. %; and Y mol. % alkali oxide, wherein the alkali oxide comprises Na.sub.2O in an amount greater than or equal to about 9 mol. % and less than or equal to about 15 mol. %, a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, and wherein the pharmaceutical composition comprises one of Filgrastim, Pegfilgrastim epoetin alfa, etanercept, recombinant human granulocyte-colony stimulating factor or an analog thereof, PEGylated recombinant human granulocyte-colony stimulating factor or an analog thereof, an erythropoiesis-stimulating glycoprotein, or a fusion protein of TNF Receptor 2 and IgG1. 16. The pharmaceutical container of claim 15, wherein the ratio of Y:X is less than or equal to about 2. 17. The pharmaceutical container of claim 15, wherein the ratio of Y:X is greater than or equal to about 1.3 and less than or equal to about 2.0. 18. The pharmaceutical container of claim 15, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1. 19. The pharmaceutical container of claim 15, wherein the alkaline earth oxide comprises from about 3 mol. % to about 7 mol. % MgO. 20. The pharmaceutical container of claim 15, wherein the alkaline earth oxide comprises CaO in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. % relative to the glass composition. 21. The pharmaceutical container of claim 15, wherein the alkali oxide further comprises K.sub.2O in an amount greater than or equal to about 0.01 mol. % and less than or equal to about 1.0 mol. %. 22. The pharmaceutical container of claim 15, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %. 23. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising: from about 74 mol. % to about 78 mol. % SiO.sub.2; alkaline earth oxide comprising both CaO and MgO, wherein the alkaline earth oxide comprises CaO in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. % relative to the glass composition, 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 2 mol. % and less than or equal to about 10 mol. %; and Y mol. % alkali oxide, wherein the alkali oxide comprises from about 0.01 mol. % to about 1.0 mol. % K.sub.2O and a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, and wherein the pharmaceutical composition comprises one of Filgrastim, Pegfilgrastim, epoetin alfa, etanercept, recombinant human granulocyte-colony stimulating factor or an analog thereof, PEGylated recombinant human granulocyte-colony stimulating factor or an analog thereof, an erythropoiesis-stimulating glycoprotein, or a fusion protein of TNF Receptor 2 and IgG1. 24. The pharmaceutical container of claim 23, wherein the ratio of Y:X is less than or equal to 2. 25. The pharmaceutical container of claim 23, wherein the ratio of Y:X is greater than or equal to 1.3 and less than or equal to 2.0. 26. The pharmaceutical container of claim 23, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1. 27. The pharmaceutical container of claim 23, wherein the glass composition is free of phosphorous and compounds of phosphorous. 28. The pharmaceutical container of claim 23, wherein the alkali oxide further comprises Na.sub.2O in an amount greater than about 8 mol. %. 29. The pharmaceutical container of claim 23, wherein the alkali oxide further comprises Na.sub.2O in an amount greater than or equal to about 2 mol. % and less than or equal to about 15 mol. %. 30. The pharmaceutical container of claim 23, wherein the alkali oxide further comprises from about 9 mol. % to about 13 mol. % Na.sub.2O. 31. The pharmaceutical container of claim 23, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %. 32. The pharmaceutical container of claim 1, wherein the pharmaceutical composition comprises Filgrastim. 33. The pharmaceutical container of claim 1, wherein the pharmaceutical composition comprises Pegfilgrastim. 34. The pharmaceutical container of claim 1, wherein the pharmaceutical composition comprises epoetin alfa. 35. The pharmaceutical container of claim 1, wherein the pharmaceutical composition comprises etanercept. 36. The pharmaceutical container of claim 15, wherein the pharmaceutical composition comprises Filgrastim. 37. The pharmaceutical container of claim 15, wherein the pharmaceutical composition comprises Pegfilgrastim. 38. The pharmaceutical container of claim 15, wherein the pharmaceutical composition comprises epoetin alfa. 39. The pharmaceutical container of claim 15, wherein the pharmaceutical composition comprises etanercept. 40. The pharmaceutical container of claim 23, wherein the pharmaceutical composition comprises Filgrastim. 41. The pharmaceutical container of claim 23, wherein the pharmaceutical composition comprises Pegfilgrastim. 42. The pharmaceutical container of claim 23, wherein the pharmaceutical composition comprises epoetin alfa. 43. The pharmaceutical container of claim 23, wherein the pharmaceutical composition comprises etanercept.

Details for Patent 9,198,829

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
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2031-10-25
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000		2031-10-25