公开(公告)号：US20100062066A1

公开(公告)日：2010-03-11

申请号：US12514763

申请日：2007-11-08

申请人： Howard Bernstein ,  Olinda Carneiro ,  Rajeev A. Jain ,  Namrata Pandit ,  Shveta Rane ,  Julie Ann Straub

发明人： Howard Bernstein ,  Olinda Carneiro ,  Rajeev A. Jain ,  Namrata Pandit ,  Shveta Rane ,  Julie Ann Straub

IPC分类号： A61K9/113 ,  A61K31/4365

CPC分类号： A61K31/4365 ,  A61K9/0019 ,  A61K9/1075 ,  A61K9/1617 ,  A61K9/19

摘要： A pharmaceutical composition for the oral or parenteral administration of a compound of Formula (I) comprising an oil in water emulsion, wherein the oil phase comprises the free base of or a pharmaceutically acceptable salt thereof of a compound of Formula (I), and one or more surfactants which are soluble in the oil phase and/or the aqueous phase. The emulsion optionally contains one or more excipients that are soluble in the oil phase and/or the aqueous phase, such as pH modifying agents such as buffers, osmolality/tonicity modifying agents, emulsifying agents, water-soluble polymers, and preservatives. The compound of Formula (I) can be formulated as a solid material and stored until needed. Kits for forming the emulsion are provided. Prior to administration, the solid material can be reconstituted in an aqueous medium to form the emulsion.

摘要翻译： 一种用于口服或肠胃外给药包含水包油乳液的式（I）化合物的药物组合物，其中所述油相包含式（I）化合物的游离碱或其药学上可接受的盐，和一种 或更多的可溶于油相和/或水相的表面活性剂。 乳液任选地含有一种或多种可溶于油相和/或水相的赋形剂，如pH调节剂如缓冲液，重量摩尔渗透压浓度/张力调节剂，乳化剂，水溶性聚合物和防腐剂。 式（I）的化合物可以配制成固体物质并储存直至需要。 提供了用于形成乳液的试剂盒。 在施用前，固体材料可以在水性介质中重构以形成乳液。