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 |