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1. 发明申请

US20020192285A1 Controlled release pellet formulation 有权
标题翻译：控释丸剂配方
公开(公告)号：US20020192285A1
公开(公告)日：2002-12-19
申请号：US10165907
申请日：2002-06-10
申请人： Nostrum Pharmaceuticals, Inc.
发明人： Nirmal Mulye
IPC分类号： A61K009/00 , A61K009/32
CPC分类号： A61K9/5078 , A61K9/5026 , A61K9/5036 , A61K9/5042 , A61K9/5047 , Y10S514/965
摘要： The present invention describes an aqueous pharmaceutical coating formulation which can be used for coating core elements containing one or more medicaments to achieve controlled release. The coated pharmaceutical formulation provides a release of medicaments in a controlled manner at highly acidic environment such as that of stomach and shows relatively faster release in media with basic pH such as that of the intestine. The coating composition is a heterogenous mixture which comprises (a) at least 75% by weight of a water insoluble polymer which is insoluble in both acidic as well as basic pH; and (b) 1 to 25% by weight of an enteric polymer which is substantially insoluble in water at a pH below 4.5 and which is substantially soluble in water at a pH between above about 6.0, said enteric polymer and water insoluble polymer being present in an amount effective to control-the release of said medicament. The pharmaceutical composition comprises a solid medicament present in effective amounts and the coating composition thereover.
摘要翻译：本发明描述了一种水性药物涂料制剂，其可用于包含含有一种或多种药物的核心元件以实现控制释放。涂覆的药物制剂在高酸性环境例如胃的情况下以受控的方式提供药物释放，并且在碱性pH如肠的培养基中显示相对较快的释放。涂料组合物是一种异质混合物，其包含（a）至少75重量％的不溶于酸性和碱性pH的水不溶性聚合物; 和（b）1至25重量％的肠溶性聚合物，其在pH低于4.5时基本上不溶于水，并且其在约6.0之间的pH基本上可溶于水，所述肠溶聚合物和水不溶性聚合物存在于有效控制所述药物释放的量。药物组合物包含有效量的固体药物和其上的涂料组合物。

2. 发明申请

US20020155156A1 Novel coating for a sustained release pharmaceutical composition 有权
标题翻译：用于缓释药物组合物的新颖涂层
公开(公告)号：US20020155156A1
公开(公告)日：2002-10-24
申请号：US10124869
申请日：2002-04-18
申请人： Nostrum Pharmaceuticals, Inc.
发明人： Nirmal Mulye
IPC分类号： A61K009/20 , A61K009/32
CPC分类号： A61K9/2826 , A61K9/2009 , A61K9/205 , A61K9/2054 , A61K9/2866
摘要： The present invention is directed to a coating composition for coating a solid dosage form of a medicament, where the coating composition controls the release of the medicament, said coating composition comprising (a) at least 50% (w/w) by dry weight of a water insoluble polymer insoluble in both acidic, basic and neutral pH, present in the form of an aqueous latex dispersion, (b) a water soluble non-polymeric component present in a weight ratio of about 5 to about 50% (w/w) by dry weight of the coating, having a molecular weight of less than about 15,000 daltons and water solubility in excess of 5 grams per 100 grams of water at room temperature at 1 atm pressure, said water soluble non-polymeric component being organic and either solid or liquid; said ratio of water insoluble polymer to water soluble non-polymeric component ranging from about 95:5 to about 1:1, the solid content in the coating composition ranges from about 5% to about 25%, said water soluble component being completely dissolved in the aqueous latex dispersion. The present invention is also directed to a system for the controlled release of an active medicament comprising a substrate and a coating, said substrate comprising a therapeutically effective amount of a medicament in association with a pharmaceutical carrier in solid unit dosage form, said substrate being uniformly coated with the aforesaid coating composition.
摘要翻译：本发明涉及用于涂覆药物的固体剂型的涂料组合物，其中所述涂料组合物控制药物的释放，所述涂料组合物包含（a）至少50重量％（w / w）不溶于酸性，碱性和中性pH的水不溶性聚合物，以水性胶乳分散体的形式存在，（b）以约5至约50％重量比（w / w）存在的水溶性非聚合物组分），其分子量小于约15,000道尔顿，水溶解度在室温1atm压力下每100克水超过5克，所述水溶性非聚合物组分为有机物，和固体或液体; 所述水不溶性聚合物与水溶性非聚合物组分的比例为约95:5至约1:1，涂料组合物中的固体含量为约5％至约25％，所述水溶性组分完全溶解于水性胶乳分散体。本发明还涉及用于控制释放包含底物和涂层的活性药物的系统，所述底物包含与固体单位剂型的药物载体结合的治疗有效量的药物，所述底物均匀地涂覆有上述涂料组合物。

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