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1. 发明申请

WO2008079290A2 FORMULATIONS 审中-公开
标题翻译：配方
公开(公告)号：WO2008079290A2
公开(公告)日：2008-07-03
申请号：PCT/US2007/026060
申请日：2007-12-19
申请人： AMGEN INC , JACOB, Jaby , MATSUMURA, Masazumi , GOKARN, Yatin , BREMS, David
发明人： JACOB, Jaby , MATSUMURA, Masazumi , GOKARN, Yatin , BREMS, David
CPC分类号： C07K16/22 , A61K9/0019 , A61K9/08 , A61K47/12 , A61K47/183 , A61K47/22 , C07K2317/94
摘要： The invention provides a formulation comprising a buffer with a pH from about 4.0 to about 6.0, proline and an effective amount of a polypeptide. The polypeptide can be an antibody. The specification also provides methods of preparing the formulation, a kit containing the formulation and methods of using the formulation.
摘要翻译：本发明提供一种包含pH为约4.0至约6.0的缓冲液，脯氨酸和有效量的多肽的制剂。多肽可以是抗体。说明书还提供了制备制剂的方法，包含制剂的试剂盒和使用制剂的方法。

2. 发明申请

WO2004002533A1 STABLE LIQUID PARENTERAL PARECOXIB FORMULATION 审中-公开
标题翻译：稳定的液体PARECOXIB配方
公开(公告)号：WO2004002533A1
公开(公告)日：2004-01-08
申请号：PCT/US2003/021028
申请日：2003-06-18
申请人： PHARMACIA CORPORATION , GOKARN, Yatin, R. , SCHARTMAN, Richard
发明人： GOKARN, Yatin, R. , SCHARTMAN, Richard
IPC分类号： A61K47/00
CPC分类号： A61K9/0014 , A61K9/0019 , A61K31/42 , A61K47/10
摘要： A parenterally deliverable pharmaceutical composition comprises a water soluble parecoxib salt, in dissolved and/or solubilized form in a solvent liquid that comprises water and one or more nonaqueous solubilizer(s). Valdecoxib formed by conversion of parecoxib is solubilized by the nonaqueous solubilizer(s), which are substantially inert with respect to such conversion. The composition has parecoxib salt stabilizing means for inhibiting precipitation of parecoxib free acid. The composition is storage stable and is suitable for parenteral administration to treat a COX-2 mediated condition or disorder.
摘要翻译：肠胃外可递送的药物组合物包含溶解和/或溶解形式的溶于水和一种或多种非水增溶剂的溶剂液体中的水溶性帕列昔西盐。通过转化帕伐卡星形成的瓦尔多昔布由非水增溶剂溶解，其对于这种转化基本上是惰性的。该组合物具有用于抑制帕瑞昔布游离酸沉淀的帕替昔西盐稳定装置。该组合物是储存稳定的，适用于肠胃外给药以治疗COX-2介导的病症或病症。

3. 发明申请

WO2015095568A1 REDUCTION OF LIPASE ACTIVITY IN PRODUCT FORMULATIONS 审中-公开
标题翻译：减少产品配方中的脂肪酶活性
公开(公告)号：WO2015095568A1
公开(公告)日：2015-06-25
申请号：PCT/US2014/071234
申请日：2014-12-18
申请人： LEE, Kelvin , LENHOFF, Abraham , VALENTE, Kristen , LEVY, Nick , GOKARN, Yatin
发明人： LEE, Kelvin , LENHOFF, Abraham , VALENTE, Kristen , LEVY, Nick , GOKARN, Yatin
IPC分类号： C12N1/08
CPC分类号： C12N15/1137 , A61K38/1709 , A61K38/1741 , A61K38/1761 , A61K38/1774 , A61K38/39 , A61K38/42 , A61K38/44 , A61K38/443 , A61K38/45 , A61K38/4813 , A61K38/482 , A61K38/488 , A61K38/52 , A61K47/26 , C07K16/00 , C12N9/20 , C12N2310/10 , C12N2310/14 , C12N2310/20 , C12P21/005 , C12P21/02 , C12Y104/03013 , C12Y111/01015 , C12Y205/01018 , C12Y207/04006 , C12Y207/11001 , C12Y301/01034 , C12Y304/16005 , C12Y304/21 , C12Y304/23005 , C12Y502/01008 , C12Y503/04001
摘要： The invention relates a method for producing a stable recombinant protein, comprising growing a non-naturally occurring host cell in a culture medium to produce a recombinant protein, and making a composition comprising the recombinant protein and a polysorbate. The production of endogenous lipoprotein lipase by the host cell is reduced. The endogenous lipoprotein lipase is present in the composition in a small amount, and is capable of degrading the polysorbate. The invention also relates to the relevant host cells and compositions, and preparation thereof.
摘要翻译：本发明涉及一种生产稳定重组蛋白的方法，包括在培养基中培养非天然存在的宿主细胞以产生重组蛋白，以及制备包含重组蛋白和聚山梨酯的组合物。由宿主细胞产生的内源性脂蛋白脂肪酶降低。内源性脂蛋白脂肪酶以少量存在于组合物中，并且能够降解聚山梨醇酯。本发明还涉及相关宿主细胞和组合物及其制备。

4. 发明申请

WO2004050123A3 CONCENTRATED LIQUID VALDECOXIB COMPOSITION 审中-公开
标题翻译：浓缩液体酸性复合组合物
公开(公告)号：WO2004050123A3
公开(公告)日：2004-07-29
申请号：PCT/US0336244
申请日：2003-11-13
申请人： PHARMACIA CORP , GOKARN YATIN R
发明人： GOKARN YATIN R
IPC分类号： A61K9/00 , A61K9/08 , A61K31/415 , A61K47/40 , A61K47/48 , A61P29/00
CPC分类号： B82Y5/00 , A61K9/0019 , A61K9/08 , A61K31/415 , A61K47/40 , A61K47/6951
摘要： The present invention provides a pharmaceutical composition comprising a liquid carrier, valdecoxib and cyclodextrin derivative in an amount of at least about 5%, w/v, of the composition. The valdecoxib is in solubilized form and, at room temperature, the ratio of valdecoxib concentration to cyclodextrin concentration is greater than is achievable in a substantially similar solution but which comprises less than 5%, w/v, of said cyclodextrin derivative.
摘要翻译：本发明提供了一种药物组合物，其包含液体载体，伐地考昔和环糊精衍生物，其量为组合物的至少约5％w / v。伐地考昔呈溶解形式，并且在室温下，伐地考昔浓度与环糊精浓度的比率大于在基本上类似的溶液中可实现的比例，但其包含小于5％w / v的所述环糊精衍生物。

5. 发明申请

WO0176639A2 CHEMICALLY-MODIFIED MYELOPOIETIN CONJUGATES 审中-公开
标题翻译：化学改性的肌醇六磷酸腺嘌呤
公开(公告)号：WO0176639A2
公开(公告)日：2001-10-18
申请号：PCT/US0111256
申请日：2001-04-06
申请人： PHARMACIA CORP , FINN RORY , GOKARN YATIN , HILLS ROBERT , NICASTRO PETER , QI HONG , SEDO KURT , SIEGEL NED , WALTER SMITH
发明人： FINN RORY , GOKARN YATIN , HILLS ROBERT , NICASTRO PETER , QI HONG , SEDO KURT , SIEGEL NED , WALTER SMITH
IPC分类号： A61K38/00 , A61K47/48 , A61P7/00 , A61P37/02 , A61P37/06 , C07K14/535 , C07K14/54
CPC分类号： C07K14/535 , A61K38/00 , A61K47/60 , C07K14/5403 , C07K2319/00
摘要： The present invention provides a chemically modified Myelopoietin (MPO) prepared by binding a water soluble polymer to the protein. The chemically-modified protein according to the present invention may have a much longer lasting neutrophil-increasing activity than that of the un-modified MPO, enabling reduced dose and scheduling opportunities.
摘要翻译：本发明提供通过将水溶性聚合物与蛋白质结合而制备的化学修饰的骨髓细胞生成素（MPO）。根据本发明的化学修饰的蛋白质可以具有比未修饰的MPO长得多的持久的中性粒细胞增加活性，能够减少剂量和调度机会。

6. 发明申请

WO2011084750A1 ANTIBODY FORMULATION 审中-公开
标题翻译：抗体配方
公开(公告)号：WO2011084750A1
公开(公告)日：2011-07-14
申请号：PCT/US2010/061347
申请日：2010-12-20
申请人： GENENTECH, INC. , F. HOFFMANN-LA ROCHE AG , GOKARN, Yatin, R. , KAMERZELL, Timothy, J. , LI, Megan , CROMWELL, Mary , LIU, Hong
发明人： GOKARN, Yatin, R. , KAMERZELL, Timothy, J. , LI, Megan , CROMWELL, Mary , LIU, Hong
IPC分类号： A61K39/395 , A61K47/18 , A61K47/26 , C07K16/22 , A61K9/00
CPC分类号： C07K16/22 , A61J1/1412 , A61J1/2006 , A61K9/0019 , A61K39/395 , A61K39/39591 , A61K47/183 , A61K47/22 , A61K47/26 , A61K2039/505 , C07K2317/76 , C07K2317/94
摘要： The invention provides a stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, optionally, not subjected to prior lyophilization, a buffer maintaining the pH in the range from about 4.0 to about 6.0, and an optional surfactant, methods for making such a formulation, and methods of using such a formulation.
摘要翻译：本发明提供了一种稳定的含水药物制剂，其包含治疗有效量的抗体，任选地不经过先前的冻干，将pH保持在约4.0至约6.0范围内的缓冲液和任选的表面活性剂，制剂和使用这种制剂的方法。

7. 发明申请

WO2007124082A3 BUFFERING AGENTS FOR BIOPHARMACEUTICAL FORMULATIONS 审中-公开
标题翻译：生物制剂制剂的缓冲剂
公开(公告)号：WO2007124082A3
公开(公告)日：2008-05-15
申请号：PCT/US2007009700
申请日：2007-04-19
申请人： AMGEN INC , GOKARN YATIN
发明人： GOKARN YATIN
IPC分类号： A61K47/12 , A61K9/08 , A61K39/395 , A61K47/26 , A61K47/34
CPC分类号： C07K16/2803 , A61K9/0019 , A61K39/39591 , A61K47/12
摘要： The invention provides a biopharmaceutical formulation including an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0, at least one excipient and an effective amount of a therapeutic polypeptide. The propionate buffer can include a concentration selected from between about 1-50 mM, 2-30 mM, 3-20 mM, 4-10 mM and 5-8 mM. The therapeutic polypeptide included in a biopharmaceutical formulation of the invention can include an antibody, Fd, Fv, Fab, F(ab'), F(ab) 2 , F(ab') 2 , single chain Fv (scFv), chimeric antibodies, diabodies, triabodies, tetrabodies, minibody, peptibody, hormone, growth factor or cell signaling molecule. The invention also provides a method of preparing a biopharmaceutical formulation. The method includes combining an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0 and at least one excipient with an effective amount of a therapeutic polypeptide.
摘要翻译：本发明提供了一种生物药物制剂，其包括具有约4.0至约6.0的pH的丙酸缓冲液的水溶液，至少一种赋形剂和有效量的治疗性多肽。丙酸盐缓冲液可以包括选自约1-50mM，2-30mM，3-20mM，4-10mM和5-8mM之间的浓度。包含在本发明的生物药物制剂中的治疗性多肽可以包括抗体Fd，Fv，Fab，F（ab'），F（ab）2，F（ab'）2 单链Fv（scFv），嵌合抗体，双抗体，三抗体，四体抗体，微型抗体，肽性抗体，激素，生长因子或细胞信号传导分子。本发明还提供了制备生物药物制剂的方法。该方法包括将具有丙酸盐缓冲液的水溶液与约4.0至约6.0的pH和至少一种赋形剂与有效量的治疗性多肽组合。

8. 发明申请

WO2008079290A3 STABLE BUFFERED FORMULATIONS CONTAINING POLYPEPTIDES 审中-公开
标题翻译：含有多糖的稳定缓冲配方
公开(公告)号：WO2008079290A3
公开(公告)日：2008-12-04
申请号：PCT/US2007026060
申请日：2007-12-19
申请人： AMGEN INC , JACOB JABY , MATSUMURA MASAZUMI , GOKARN YATIN , BREMS DAVID
发明人： JACOB JABY , MATSUMURA MASAZUMI , GOKARN YATIN , BREMS DAVID
IPC分类号： A61K47/22 , A61K9/08 , A61K39/395 , A61K47/18
CPC分类号： C07K16/22 , A61K9/0019 , A61K9/08 , A61K47/12 , A61K47/183 , A61K47/22 , C07K2317/94
摘要： The invention provides a formulation comprising a buffer with a pH from about 4.0 to about 6.0, proline and an effective amount of a polypeptide. The polypeptide can be an antibody. The specification also provides methods of preparing the formulation, a kit containing the formulation and methods of using the formulation.
摘要翻译：本发明提供一种包含pH为约4.0至约6.0的缓冲液，脯氨酸和有效量的多肽的制剂。多肽可以是抗体。说明书还提供了制备制剂的方法，包含制剂的试剂盒和使用该制剂的方法。

9. 发明申请

WO2006138181A3 SELF-BUFFERING PROTEIN FORMULATIONS 审中-公开
标题翻译：自我缓冲蛋白质配方
公开(公告)号：WO2006138181A3
公开(公告)日：2007-12-06
申请号：PCT/US2006022599
申请日：2006-06-08
申请人： AMGEN INC , GOKARN YATIN R , KRAS EVA , REMMELE RICHARD LOUIS JR , BREMS DAVID N , HERSHENSON SUSAN IRENE
发明人： GOKARN YATIN R , KRAS EVA , REMMELE RICHARD LOUIS JR , BREMS DAVID N , HERSHENSON SUSAN IRENE
IPC分类号： A61K39/395 , C12P21/08
CPC分类号： A61K39/3955 , A61K9/08 , A61K39/39591 , A61K47/10 , A61K47/26 , C07K16/241 , C07K16/2803 , C07K16/2827 , C07K16/2851 , C07K16/2866 , C07K16/2875 , C07K2317/21 , C07K2317/565 , C07K2317/94
摘要： The invention herein described, provides, among other things, self-buffering protein formulations. Particularly, the invention provides self-buffering pharmaceutical protein formulations that are suitable for veterinary and human medical use. The self-buffering protein formulations are substantially free of other buffering agents, stably maintain pH for the extended time periods involved in the distribution and storage of pharmaceutical proteins for veterinary and human medical use. The invention further provides methods for designing, making, and using the formulation. In addition to other advantages, the formulations avoid the disadvantages associated with the buffering agents conventionally used in current formulations of proteins for pharmaceutical use. The invention in these and other respects can be productively applied to a wide variety of proteins and is particularly useful for making and using self-buffering formulations of pharmaceutical proteins for veterinary and medical use, especially, in particular, for the treatment of diseases in human subjects.
摘要翻译：本文所述的本发明尤其提供了自缓冲蛋白制剂。特别地，本发明提供了适用于兽医和人类医学用途的自缓冲药物蛋白质制剂。自缓冲蛋白质制剂基本上不含其它缓冲剂，在用于兽医和人类医疗用途的药物蛋白质的分配和储存中涉及的延长时间段内稳定地保持pH。本发明还提供了用于设计，制造和使用制剂的方法。除了其它优点之外，制剂避免了与当前用于药物用途的蛋白质制剂中常规使用的缓冲剂相关的缺点。这些和其他方面的发明可以有效地应用于多种蛋白质，并且特别可用于制备和使用用于兽医和医疗用途的药物蛋白质的自缓冲制剂，特别是用于治疗人类疾病科目。

10. 发明申请

WO2007124082A2 BUFFERING AGENTS FOR BIOPHARMACEUTICAL FORMULATIONS 审中-公开
标题翻译：生物制剂制剂的缓冲剂
公开(公告)号：WO2007124082A2
公开(公告)日：2007-11-01
申请号：PCT/US2007/009700
申请日：2007-04-19
申请人： AMGEN, INC. , GOKARN, Yatin
发明人： GOKARN, Yatin
IPC分类号： A61K47/26 , A61K47/34 , A61K39/395
CPC分类号： C07K16/2803 , A61K9/0019 , A61K39/39591 , A61K47/12
摘要： The invention provides a biopharmaceutical formulation including an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0, at least one excipient and an effective amount of a therapeutic polypeptide. The propionate buffer can include a concentration selected from between about 1-50 mM, 2-30 mM, 3-20 mM, 4-10 mM and 5-8 mM. The therapeutic polypeptide included in a biopharmaceutical formulation of the invention can include an antibody, Fd, Fv, Fab, F(ab'), F(ab) 2 , F(ab') 2 , single chain Fv (scFv), chimeric antibodies, diabodies, triabodies, tetrabodies, minibody, peptibody, hormone, growth factor or cell signaling molecule. The invention also provides a method of preparing a biopharmaceutical formulation. The method includes combining an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0 and at least one excipient with an effective amount of a therapeutic polypeptide.
摘要翻译：本发明提供了一种生物药物制剂，其包括具有约4.0至约6.0的pH的丙酸缓冲液的水溶液，至少一种赋形剂和有效量的治疗性多肽。丙酸盐缓冲液可以包括选自约1-50mM，2-30mM，3-20mM，4-10mM和5-8mM之间的浓度。包含在本发明的生物药物制剂中的治疗性多肽可以包括抗体Fd，Fv，Fab，F（ab'），F（ab）2，F（ab'）2 单链Fv（scFv），嵌合抗体，双抗体，三抗体，四体抗体，微型抗体，肽性抗体，激素，生长因子或细胞信号传导分子。本发明还提供了制备生物药物制剂的方法。该方法包括将具有丙酸盐缓冲液的水溶液与约4.0至约6.0的pH和至少一种赋形剂与有效量的治疗性多肽组合。

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