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公开(公告)号：EP1244444B1
公开(公告)日：2004-12-29
申请号：EP00974020.0
申请日：2000-10-27
申请人： Merck & Co., Inc.
发明人： AL-DEHNEH, Anthony , HUNKE, William, A. , ILLIG, Kathleen, J. , KANIKE, Anand , PATEL, Hiren , REYNOLDS, Scott, D. , TSINONTIDES, Stelios, C.
IPC分类号： A61K31/407 , A61P31/04 , C07D487/04 , C07D477/20 , A61K31/40 , C07D477/02
CPC分类号： C07D477/20 , A61K31/407 , C07D477/02
摘要： A novel process for preparing a stabilized, lyophilized carbapenem, antibiotic formulation suitable for intravenous administration to patients in need thereof, wherein the active ingredient is of formula (II). The process entails compounding an unstable, monosodium salt carbapenem with a sodium bicarbonate solution at a temperature range of from about 0° to about 5°C while maintaining a pH between about 7.0 and about 8.0, filtering the resultant solution, bottling under sterile conditions, and lyophilizing to produce the formulation.
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公开(公告)号：EP1332145B1
公开(公告)日：2007-11-14
申请号：EP01934937.2
申请日：2001-04-27
申请人： Merck & Co., Inc.
发明人： AL-DEHNEH, Anthony , HUNKE, William, A. , ILLIG, Kathleen, J. , KANIKE, Anand , PATEL, Hiren , REYNOLDS, Scott, D. , TSINONTIDES, Stelios, C.
IPC分类号： C07D477/20 , A61K31/40 , A61K31/407
CPC分类号： C07D477/20 , A61K31/40 , A61K31/407 , C07D477/02
摘要： The present invention involves a process for preparing a stable final formulation product of a compound of formula (I) or its pharmaceutically acceptable salt, hydrate or solvate by incorporating a suitable carbon dioxide source to an unstable monosodium adduct of carbapenem antibiotic compound.
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公开(公告)号：EP1332145A1
公开(公告)日：2003-08-06
申请号：EP01934937.2
申请日：2001-04-27
申请人： Merck & Co., Inc.
发明人： AL-DEHNEH, Anthony , HUNKE, William, A. , ILLIG, Kathleen, J. , KANIKE, Anand , PATEL, Hiren , REYNOLDS, Scott, D. , TSINONTIDES, Stelios, C.
IPC分类号： C07D477/20 , A61K31/40
CPC分类号： C07D477/20 , A61K31/40 , A61K31/407 , C07D477/02
摘要： The present invention involves a process for preparing a stable final formulation product of a compound of formula (I) or its pharmaceutically acceptable salt, hydrate or solvate by incorporating a suitable carbon dioxide source to an unstable monosodium adduct of carbapenem antibiotic compound.
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公开(公告)号：EP0904098B1
公开(公告)日：2003-06-04
申请号：EP97921205.7
申请日：1997-04-15
申请人： MERCK & CO., INC.
CPC分类号： A61K38/12
摘要： The invention is a pharmaceutical composition for intravenous administration to a patient comprising a) a pharmaceutically effective amount of a compound having the formula (I) and the pharmaceutically acceptable salts thereof; b) a pharmaceutically acceptable amount of an excipient such as a bulking agent effective to form a lyophilized cake; and c) a pharmaceutically acceptable amount of acetate buffer effective to provide a pH of between about 4 and 7.
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公开(公告)号：EP0863901B1
公开(公告)日：2003-10-22
申请号：EP97925725.0
申请日：1997-05-23
申请人： MERCK & CO., INC.
发明人： ZIMMERMAN, Jeffrey, A. , WILLIAMS, John, M. , BERGQUIST, Paul, A. , DiMICHELE, Lisa, M. , DuBOST, David, C. , KAUFMAN, Michael, J. , SIDLER, Daniel, R. , HUNKE, William, A.
IPC分类号： C07D477/20 , A61K31/40
CPC分类号： C07D477/20 , A61K31/407
摘要： A pharmaceutical composition is disclosed which contains a compound of formula (I) or a pharmaceutically acceptable salt, prodrug or hydrate thereof, in the stabilized form and/or in combination with a carbon dioxide source.
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公开(公告)号：EP1244444A1
公开(公告)日：2002-10-02
申请号：EP00974020.0
申请日：2000-10-27
申请人： Merck & Co., Inc.
发明人： AL-DEHNEH, Anthony , HUNKE, William, A. , ILLIG, Kathleen, J. , KANIKE, Anand , PATEL, Hiren , REYNOLDS, Scott, D. , TSINONTIDES, Stelios, C.
IPC分类号： A61K31/407 , A61P31/04 , C07D487/04
CPC分类号： C07D477/20 , A61K31/407 , C07D477/02
摘要： A novel process for preparing a stabilized, lyophilized carbapenem, antibiotic formulation suitable for intravenous administration to patients in need thereof, wherein the active ingredient is of formula (II). The process entails compounding an unstable, monosodium salt carbapenem with a sodium bicarbonate solution at a temperature range of from about 0° to about 5°C while maintaining a pH between about 7.0 and about 8.0, filtering the resultant solution, bottling under sterile conditions, and lyophilizing to produce the formulation.
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公开(公告)号：EP1007054A1
公开(公告)日：2000-06-14
申请号：EP97945195.2
申请日：1997-10-02
申请人： MERCK & CO., INC.
IPC分类号： A61K31/66
CPC分类号： A61K9/0095 , A61K31/663
摘要： A liquid formulation of alendronic acid, or pharmaceutically acceptable salt has enough buffer so that the pH of the formulation is 4-7.5, and 15 ml of the formulation is able to raise the pH of 50 ml of 0.1N HC1 from 1 to at least 3, and preferably 4.
摘要翻译： 阿仑膦酸或其药学上可接受的盐的液体制剂具有足够的缓冲剂以使制剂的pH为4-7.5，并且15ml制剂能够将50ml 0.1N HCl的pH从1升高至至少 3，最好是4。
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公开(公告)号：EP0904098A1
公开(公告)日：1999-03-31
申请号：EP97921205.0
申请日：1997-04-15
申请人： MERCK & CO., INC.
CPC分类号： A61K38/12
摘要： The invention is a pharmaceutical composition for intravenous administration to a patient comprising a) a pharmaceutically effective amount of a compound having the formula (I) and the pharmaceutically acceptable salts thereof; b) a pharmaceutically acceptable amount of an excipient such as a bulking agent effective to form a lyophilized cake; and c) a pharmaceutically acceptable amount of acetate buffer effective to provide a pH of between about 4 and 7.
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公开(公告)号：EP0863901A1
公开(公告)日：1998-09-16
申请号：EP97925725.0
申请日：1997-05-23
申请人： MERCK & CO., INC.
发明人： ZIMMERMAN, Jeffrey, A. , WILLIAMS, John, M. , BERGQUIST, Paul, A. , DiMICHELE, Lisa, M. , DuBOST, David, C. , KAUFMAN, Michael, J. , SIDLER, Daniel, R. , HUNKE, William, A.
CPC分类号： C07D477/20 , A61K31/407
摘要： A pharmaceutical composition is disclosed which contains a compound of formula (I) or a pharmaceutically acceptable salt, prodrug or hydrate thereof, in the stabilized form and/or in combination with a carbon dioxide source.
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