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US 2013/0295191 A1Published application
Stable Formulations for Lyophilizing Therapeutic Particles
AssigneeBIND Therapeutics, Inc.
InventorsGreg Troiano, Young-Ho Song, Stephen E. Zale, James Wright, Christina Van Geen Hoven
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Abstract
The present disclosure generally relates to lyophilized pharmaceutical compositions comprising polymeric nanoparticles which, upon reconstitution, have low levels of greater than 10 micron size particles. Other aspects of the invention include methods of making such nanoparticles.
Claims11
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;
- sucrose or trehalose;
- 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 sucrose or trehalose;
- and 7 to 12 weight percent of the hydroxypropyl β-cyclodextrin.
4 more elements
A 10 mL container comprising:
- 40 mg/mL or more concentration of polymeric nanoparticles comprising a poly(lactic) acid-block-poly(ethylene)glycol copolymer and docetaxel in an aqueous solution;
- 4 to 6 weight percent sucrose or trehalose;
- and
- 7 to 12 weight percent hydroxypropyl β-cyclodextrin;
- wherein the container has less than 600 particles having a size greater than or equal to 10 microns.
2 more elements
An aqueous pharmaceutical composition comprising:
- polymeric nanoparticles comprising a poly(lactic) acid-block-poly(ethylene)glycol copolymer, and a therapeutic agent, wherein the poly(lactic) acid portion of the copolymer has a weight average molecular weight of about 16 kDa and the poly(ethylene)glycol portion of the copolymer has a weight average molecular weight of about 5 kDa;
- 4 to 6 weight percent sucrose or trehalose;
- and
- 7 to 12 weight percent hydroxypropyl β-cyclodextrin.
1 more element
Dependencies are inferred from the claim text.