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公开(公告)号：EP2946765B1
公开(公告)日：2016-08-31
申请号：EP14169753.2
申请日：2014-05-23
申请人： ARES TRADING S.A.
CPC分类号： A61K39/39591 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/12 , A61K47/26 , A61K2039/505 , A61K2039/54 , C07K16/241 , C07K2317/21 , C07K2317/76
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公开(公告)号：EP2946765A1
公开(公告)日：2015-11-25
申请号：EP14169753.2
申请日：2014-05-23
申请人： ARES TRADING S.A.
CPC分类号： A61K39/39591 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/12 , A61K47/26 , A61K2039/505 , A61K2039/54 , C07K16/241 , C07K2317/21 , C07K2317/76
摘要： The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an acetate buffering agent/system such as sodium acetate/acetic acid, and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
摘要翻译： 本发明涉及阿达木单抗的新型液体药物组合物，其包括阿达木单抗或其生物相似物，乙酸盐缓冲剂/体系如乙酸钠/乙酸和糖稳定剂如海藻糖。 这样的组合组合物提供具有稳定性（例如在储存和暴露于应力时）的制剂，其与本领域已知的那些相当或者改进，并且具有较少的成分。 这些进展将有助于阿达木单抗治疗以更低的成本更广泛地获得，并且延长预加载递送装置（例如预装注射器）的生存能力，以减少不必要的药物浪费。
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3.发明公开Liquid stabilized protein formulations in coated pharmaceutical containers 审中-公开StabilisierteFlüssigeProteinzubereitungen在beschichteten pharmazeutischenBehältnissen
公开(公告)号：EP2324845A1
公开(公告)日：2011-05-25
申请号：EP11152658.8
申请日：2004-05-12
申请人： Ares Trading S.A.
CPC分类号： A61K9/0019 , A61J1/1468 , A61K38/215 , A61K47/10 , A61K47/183 , A61K47/26 , B65D51/002 , B65D51/005 , B65D81/24
摘要： A container comprising a closure means coated by an inert fluorinated material and containing a liquid pharmaceutical composition. In particular, the container comprises a closure means coated by TEFLON and contains a HSA-free Interferon-β formulation having the following composition: 30 to 100 µg/ml of interferon-β, an isotonicity agent, 0.1 to 2 mg/ml of Poloxamer 188, at least 0.12 mg/ml of L-Methionine and a buffer solution capable of maintaining the pH of the liquid formulation at a value between 3.0 and 4.0.
摘要翻译： 一种容器，其包括用惰性氟化材料涂覆并含有液体药物组合物的封闭装置。 特别地，容器包括由TEFLON涂覆的封闭装置，并且包含具有以下组成的无HSA干扰素-2制剂：30至100μg/ ml干扰素-2，等渗剂，0.1至2mg / ml泊洛沙姆 188，至少0.12mg / ml的L-甲硫氨酸和能够将液体制剂的pH保持在3.0和4.0之间的值的缓冲溶液。
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公开(公告)号：EP2946767B1
公开(公告)日：2016-10-05
申请号：EP14169755.7
申请日：2014-05-23
申请人： ARES TRADING S.A.
IPC分类号： A61K9/00
CPC分类号： A61K39/39591 , A61K9/0019 , A61K47/12 , A61K47/26 , C07K16/241 , C07K2317/21 , C07K2317/94
摘要： The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, a citrate buffering agent/system such as sodium citrate/citric acid, and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
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公开(公告)号：EP2946767A1
公开(公告)日：2015-11-25
申请号：EP14169755.7
申请日：2014-05-23
申请人： ARES TRADING S.A.
IPC分类号： A61K9/00
CPC分类号： A61K39/39591 , A61K9/0019 , A61K47/12 , A61K47/26 , C07K16/241 , C07K2317/21 , C07K2317/94
摘要： The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, a citrate buffering agent/system such as sodium citrate/citric acid, and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
摘要翻译： 本发明涉及阿达木单抗的新型液体药物组合物，其包括阿达木单抗或其生物相似物，柠檬酸盐缓冲剂/体系如柠檬酸钠/柠檬酸，和糖稳定剂如海藻糖。 这样的组分组合提供了具有稳定性（例如储存时和暴露于压力时）的制剂，其与本领域已知的那些相当或有所改进，并具有较少的成分。 这些进步将有助于阿达木单抗治疗以更低的成本变得更广泛地获得，并且延长预加载递送装置（例如预填充注射器）的可行性以减少药物的不必要浪费。
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公开(公告)号：EP2946766B1
公开(公告)日：2016-03-02
申请号：EP14169754.0
申请日：2014-05-23
申请人： ARES TRADING S.A.
CPC分类号： A61K39/39591 , A61K9/0019 , A61K47/183 , A61K47/26 , C07K16/241 , C07K2317/21 , C07K2317/76
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公开(公告)号：EP2946766A1
公开(公告)日：2015-11-25
申请号：EP14169754.0
申请日：2014-05-23
申请人： ARES TRADING S.A.
CPC分类号： A61K39/39591 , A61K9/0019 , A61K47/183 , A61K47/26 , C07K16/241 , C07K2317/21 , C07K2317/76
摘要： The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an histidine buffering agent such as histidine (or histidine buffer system such as histidine/imidiazolium-histidine), and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
摘要翻译： 本发明涉及阿达木单抗的新型液体药物组合物，其包括阿达木单抗或其生物相似物，组氨酸缓冲剂例如组氨酸（或组氨酸缓冲体系，例如组氨酸/咪唑鎓 - 组氨酸）和糖稳定剂例如海藻糖。 这样的组分组合提供了具有稳定性（例如储存时和暴露于压力时）的制剂，其与本领域已知的那些相当或有所改进，并具有较少的成分。 这些进步将有助于阿达木单抗治疗以更低的成本变得更广泛地获得，并且延长预加载递送装置（例如预填充注射器）的可行性以减少药物的不必要浪费。
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