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公开(公告)号：US20100120906A1
公开(公告)日：2010-05-13
申请号：US12505409
申请日：2009-07-17
申请人： Biljana Nadjsombati
发明人： Biljana Nadjsombati
CPC分类号： A61K31/44 , A61K9/2009 , A61K9/2013 , A61K9/2027 , A61K9/2054
摘要： A modified release pharmaceutical formulation includes about 30-70% N-(2-amino-4-(fluorobenzylamino)-phenyl)carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof, about 5-30% of a drug delivery matrix including hydroxypropylmethylcellulose (HPMC), about 1.0-10% of an anionic surfactant, and an enteric polymer. The pharmaceutical formulation produces a sustained plasma concentration of retigabine following administration to a subject for 4-20 hours longer than the time required for in vitro release of 80% of retigabine. A formulation includes about 30-70% N-(2-amino-4-(fluorobenzylamino)-phenyl)carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof, about 5-30% of a drug delivery matrix, and an agent for retarding release in the gastric environment. The plasma concentration vs. time profile of this formulation is substantially flat over an extended period lasting for about 4 hours to about 36 hours. A method of treating a disorder characterized by nervous system hyperexcitability includes administering to a subject an effective amount of these pharmaceutical formulations.
摘要翻译： 一种改性释放药物制剂包括约30-70％的N-（2-氨基-4-（氟苄基氨基） - 苯基）氨基甲酸乙酯（瑞替加滨）或其药学上可接受的盐，溶剂合物或水合物，约5-30％ 的药物递送基质，包括羟丙基甲基纤维素（HPMC），约1.0-10％的阴离子表面活性剂和肠溶性聚合物。 给予受试者后，药物制剂产生持续的血浆浓度，持续4-20小时比体外释放80％瑞替加滨所需的时间长。 制剂包括约30-70％的N-（2-氨基-4-（氟苄基氨基） - 苯基）氨基甲酸乙酯（瑞替加）或其药学上可接受的盐，溶剂合物或水合物，约5-30％的药物 递送基质和用于在胃环境中缓释释放的药剂。 该制剂的血浆浓度对时间曲线在持续约4小时至约36小时的延长时间内基本平坦。 治疗以神经系统兴奋性为特征的疾病的方法包括向受试者施用有效量的这些药物制剂。
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公开(公告)号：US20100323016A1
公开(公告)日：2010-12-23
申请号：US12691680
申请日：2010-01-21
申请人： Biljana Nadjsombati
发明人： Biljana Nadjsombati
CPC分类号： A61K9/2009 , A61K9/2013 , A61K9/2027 , A61K9/2054 , A61K9/2086 , A61K9/209 , A61K9/2846 , A61K31/27 , A61K31/44
摘要： A modified release pharmaceutical formulation includes about 30-70% N-(2-amino-4-(fluorobenzylamino)-phenyl)carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof, about 5-30% of a drug delivery matrix including hydroxypropylmethylcellulose (HPMC), and an enteric polymer. The pharmaceutical formulation produces a sustained plasma concentration of retigabine following administration to a subject for 4-20 hours longer than the time required for in vitro release of 80% of retigabine. The plasma concentration vs. time profile of this formulation is substantially flat over an extended period lasting for about 4 hours to about 36 hours. A method of treating a disorder characterized by nervous system hyperexcitability includes administering to a subject an effective amount of these pharmaceutical formulations.
摘要翻译： 一种改性释放药物制剂包括约30-70％的N-（2-氨基-4-（氟苄基氨基） - 苯基）氨基甲酸乙酯（瑞替加滨）或其药学上可接受的盐，溶剂合物或水合物，约5-30％ 的药物递送基质，包括羟丙基甲基纤维素（HPMC）和肠溶性聚合物。 给予受试者后，药物制剂产生持续的血浆浓度，持续4-20小时比体外释放80％瑞替加滨所需的时间长。 该制剂的血浆浓度对时间曲线在持续约4小时至约36小时的延长时间内基本平坦。 治疗以神经系统兴奋性为特征的疾病的方法包括向受试者施用有效量的这些药物制剂。
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公开(公告)号：US20100323015A1
公开(公告)日：2010-12-23
申请号：US12690889
申请日：2010-01-20
申请人： Biljana Nadjsombati
发明人： Biljana Nadjsombati
CPC分类号： A61K9/2009 , A61K9/2013 , A61K9/2027 , A61K9/2054 , A61K9/209 , A61K9/2846 , A61K31/27 , A61K31/44
摘要： A modified release pharmaceutical formulation includes about 30-70% N-(2-amino-4-(fluorobenzylamino)-phenyl) carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof, about 5-30% of a drug delivery matrix including hydroxypropylmethylcellulose (HPMC), and an enteric polymer. The pharmaceutical formulation produces a sustained plasma concentration of retigabine following administration to a subject for 4-20 hours longer than the time required for in vitro release of 80% of retigabine. The plasma concentration vs. time profile of this formulation is substantially flat over an extended period lasting for about 4 hours to about 36 hours. A method of treating a disorder characterized by nervous system hyperexcitability includes administering to a subject an effective amount of these pharmaceutical formulations.
摘要翻译： 一种改性释放药物制剂包括约30-70％的N-（2-氨基-4-（氟苄基氨基） - 苯基）氨基甲酸乙酯（瑞替加滨）或其药学上可接受的盐，溶剂合物或水合物，约5-30％ 的药物递送基质，包括羟丙基甲基纤维素（HPMC）和肠溶性聚合物。 给予受试者后，药物制剂产生持续的血浆浓度，持续4-20小时比体外释放80％瑞替加滨所需的时间长。 该制剂的血浆浓度对时间曲线在持续约4小时至约36小时的延长时间内基本平坦。 治疗以神经系统兴奋性为特征的疾病的方法包括向受试者施用有效量的这些药物制剂。
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