Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
C03C-004/00
A61J-001/00
A61K-039/395
C03C-003/087
C03C-003/091
C03C-021/00
C03C-004/20
출원번호
US-0660695
(2012-10-25)
등록번호
US-9241869
(2016-01-26)
발명자
/ 주소
Weeks, Wendell Porter
Schaut, Robert Anthony
DeMartino, Steven Edward
Peanasky, John Stephen
출원인 / 주소
Corning Incorporated
대리인 / 주소
Panian, Michael G.
인용정보
피인용 횟수 :
13인용 특허 :
34
초록▼
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 containe
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, LEVEMIR, NOVOLOG, NOVOLIN 70-30, NOVOLIN R, NOVOLIN N, NOVOLOG MIX 70-30 and NOVOLIN L.
대표청구항▼
1. A delamination resistant pharmaceutical container comprising a pharmaceutical composition, wherein the pharmaceutical container comprises a glass composition comprising: SiO2 in a concentration greater than about 74 mol. %;alkaline earth oxide comprising MgO and CaO, wherein CaO is present in an
1. A delamination resistant pharmaceutical container comprising a pharmaceutical composition, wherein the pharmaceutical container comprises a glass composition comprising: SiO2 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. %, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5; andY mol. % alkali oxide, wherein the alkali oxide comprises Na2O in an amount greater than about 8 mol. %, wherein the glass composition is free of boron and compounds of boron, wherein the pharmaceutical composition comprises one of human insulin detemir, human insulin aspart, 70% human insulin isophane suspension and 30% regular human insulin, regular human insulin, human insulin isophane suspension, 70% human insulin aspart protamine suspension and 30% human insulin aspart, lente insulin or an insulin analog. 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 pharmaceutical composition comprises an insulin analog. 6. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is selected from the group consisting of human insulin detemir, human insulin aspart, 70% human insulin isophane suspension and 30% regular human insulin, regular human insulin, human insulin isophane suspension, 70% human insulin aspart protamine suspension and 30% human insulin aspart and lente insulin. 7. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is human insulin detemir. 8. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is human insulin aspart. 9. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is 70% human insulin isophane suspension and 30% regular human insulin. 10. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is regular human insulin. 11. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is human insulin isophane suspension. 12. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is 70% human insulin aspart protamine suspension and 30% human insulin aspart. 13. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is lente insulin. 14. The pharmaceutical container of claim 1, wherein the concentration of SiO2 is less than or equal to about 80 mol. %. 15. The pharmaceutical container of claim 1, wherein the glass composition is free from phosphorous and compounds of phosphorous. 16. The pharmaceutical container of claim 1, further comprising X mol. % Al2O3, wherein a ratio of Y:X is greater than 1. 17. The pharmaceutical container of claim 16, wherein the ratio of Y:X is less than or equal to 2. 18. The pharmaceutical container of claim 16, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %. 19. The pharmaceutical container of claim 16, wherein the alkaline earth oxide is present in an amount from about 3 mol. % to about 13 mol. %. 20. The pharmaceutical container of claim 16, wherein the ratio of Y:X is greater than or equal 1.3 and less than or equal to 2. 21. The pharmaceutical container of claim 16, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %. 22. The pharmaceutical container of claim 1, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.3. 23. The pharmaceutical container of claim 1, further comprising SnO2. 24. A delamination resistant pharmaceutical container comprising a pharmaceutical composition, wherein the pharmaceutical container comprises a glass composition comprising: from about 74 mol. % to about 78 mol. % SiO2;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. % Al2O3, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %; andY mol. % alkali oxide, wherein the alkali oxide comprises Na2O 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, wherein the pharmaceutical composition comprises one of human insulin detemir, human insulin aspart, 70% human insulin isophane suspension and 30% regular human insulin, regular human insulin, human insulin isophane suspension, 70% human insulin aspart protamine suspension and 30% human insulin aspart, lente insulin or an insulin analog. 25. The pharmaceutical container of claim 24, wherein the ratio of Y:X is less than or equal to about 2. 26. The pharmaceutical container of claim 24, wherein the ratio of Y:X is greater than or equal to about 1.3 and less than or equal to about 2.0. 27. The pharmaceutical container of claim 24, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1. 28. The pharmaceutical container of claim 24, wherein the alkaline earth oxide comprises from about 3 mol. % to about 7 mol. % MgO. 29. The pharmaceutical container of claim 24, 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. %. 30. The pharmaceutical container of claim 24, wherein the alkali oxide further comprises K2O in an amount greater than or equal to about 0.01 mol. % and less than or equal to about 1.0 mol. %. 31. The pharmaceutical container of claim 24, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %. 32. A delamination resistant pharmaceutical container comprising a pharmaceutical composition, wherein the pharmaceutical container comprises a glass composition comprising: from about 74 mol. % to about 78 mol. % SiO2,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. %, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5;X mol. % Al2O3, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %; andY mol. % alkali oxide, wherein the alkali oxide comprises from about 0.01 mol. % to about 1.0 mol. % K2O and a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, wherein the pharmaceutical composition comprises one of LEVEMIR® human insulin detemir, human insulin aspart, 70% human insulin isophane suspension and 30% regular human insulin, regular human insulin, human insulin isophane suspension, 70% human insulin aspart protamine suspension and 30% human insulin aspart, lente insulin or an insulin analog. 33. The pharmaceutical container of claim 32, wherein the ratio of Y:X is less than or equal to 2. 34. The pharmaceutical container of claim 32, wherein the ratio of Y:X is greater than or equal to 1.3 and less than or equal to 2.0. 35. The pharmaceutical container of claim 32, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1. 36. The pharmaceutical container of claim 32, wherein the glass composition is free of phosphorous and compounds of phosphorous. 37. The pharmaceutical container of claim 32, wherein the alkali oxide further comprises Na2O in an amount greater than about 8 mol. %. 38. The pharmaceutical container of claim 32, wherein the alkali oxide further comprises Na2O in an amount greater than or equal to about 2 mol. % and less than or equal to about 15 mol. %. 39. The pharmaceutical container of claim 32, wherein the alkali oxide further comprises from about 9 mol. % to about 13 mol. % Na2O. 40. The pharmaceutical container of claim 32, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %.
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