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US 2013/0295183 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.
Claims22
A reconstituted lyophilized pharmaceutical composition suitable for parenteral administration comprising:
- a 10-100 mg/mL concentration of polymeric nanoparticles in an aqueous medium;
- wherein the polymeric nanoparticles comprise:
- a poly(lactic) acid-block-poly(ethylene)glycol copolymer or poly(lactic)-co-poly(glycolic) acid-block-poly(ethylene)glycol copolymer, and a taxane agent;
- 4 to 6 weight percent sucrose or trehalose;
- and
- 7 to 12 weight percent hydroxypropyl β-cyclodextrin.
3 more elements
A pharmaceutically acceptable aqueous solution comprising:
- about 40-60 mg/mL polymeric nanoparticles, wherein the nanoparticles comprise a poly(lactic) acid-block-poly(ethylene)glycol copolymer or poly(lactic)-co-poly(glycolic) acid-block-poly(ethylene)glycol copolymer, and a taxane;
- about 7 to about 12 weight percent hydroxypropyl β-cyclodextrin;
- and
- about 4 to about 6 weight percent sucrose.
1 more element
A reconstituted lyophilized pharmaceutical composition suitable for parenteral administration comprising:
- a 10-100 mg/mL concentration of polymeric nanoparticles in an aqueous medium;
- wherein the polymeric nanoparticles comprise:
- a poly(lactic) acid-block-poly(ethylene)glycol copolymer and docetaxel;
- 4 to 6 weight percent sucrose or trehalose;
- and
- 7 to 12 weight percent hydroxypropyl β-cyclodextrin.
3 more elements
Dependencies are inferred from the claim text.