Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61J-001/00
A61J-001/14
C03C-003/087
C03C-003/091
C03C-004/20
C03C-021/00
A61K-039/12
A61K-039/00
출원번호
US-0259281
(2014-04-23)
등록번호
US-9849066
(2017-12-26)
발명자
/ 주소
Weeks, Wendell P.
Schaut, Robert Anthony
DeMartino, Steven Edward
Peanasky, John Stephen
출원인 / 주소
Corning Incorporated
대리인 / 주소
Panian, Michael G.
인용정보
피인용 횟수 :
0인용 특허 :
57
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, PEDIARIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine), HAVRIX® (Hepatitis A Vaccine), ENGERIX-B® (Hepatitis B Vaccine (Recombinant)), TWINRIX® (Hepatitis A & Hepatitis B (Recombinant) Vaccine), EPERZAN® (albiglutide), MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (astuprotimut-R), GSK2402968 (drisapersen), and HZ/su (herpes zoster vaccine).
대표청구항▼
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 (R
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 comprisingSiO2 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. % Al2O3, 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 Na2O in an amount greater than 8 mol. %; anda ratio of a concentration of B2O3 (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 μm. 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 μm, 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 μm. 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 μm. 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 μm. 12. The packaged pharmaceutical composition of claim 1, wherein the glass pharmaceutical container comprises an internal homogeneous layer.
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