发明名称 Stable formulations for lyophilizing therapeutic particles
摘要 The present disclosure generally relates to lyophilized pharmaceutical compositions comprising a sugar, a cyclodextrin, and polymeric nanoparticles comprising a copolymer and a therapeutic agent which, upon reconstitution, have low levels of greater than 10 micron size particles. Other aspects of the invention include methods of making such nanoparticles.
申请公布号 US9498443(B2) 申请公布日期 2016.11.22
申请号 US201414535713 申请日期 2014.11.07
申请人 Pfizer Inc. 发明人 Troiano Greg;Song Young-Ho;Zale Stephen E.;Wright James;Van Geen Hoven Christina
分类号 A61K31/335;A61K31/337;A61K47/26;A61K47/34;A61K47/40;A61K9/16;A61K9/19;A61K9/00;A61K9/51 主分类号 A61K31/335
代理机构 Goodwin Proctor LLP 代理人 Goodwin Proctor LLP
主权项 1. A lyophilized pharmaceutical composition comprising: polymeric nanoparticles comprising: a poly(lactic) acid-block-poly(ethylene)glycol copolymer or poly(lactic)-co-poly(glycolic) acid-block-poly(ethylene)glycol copolymer, and a therapeutic agent; a sugar; and hydroxypropyl β-cyclodextrin, wherein upon reconstitution of the lyophilized pharmaceutical composition in an aqueous medium, the composition comprises 4 to 6 weight percent of the sugar; and 7 to 12 weight percent of the hydroxypropyl β-cyclodextrin.
地址 New York NY US