Stable formulations for lyophilizing therapeutic particles
AssigneePfizer Inc.
InventorsUjjwal Joshi, Susan Low, Young-Ho Song, Jeanne Tran, Greg Troiano
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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.
Claims29
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 alcohol;
- and
- a cyclodextrin.
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20-21. (canceled)
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26-28. (canceled)
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 therapeutic agent;
- about 6 to about 10 weight percent of mannitol;
- and
- about 6 to about 9 weight percent of hydroxypropyl β-cyclodextrin.
30-33. (canceled)
A method of preparing a lyophilized pharmaceutical composition suitable for parenteral administration upon reconstitution, comprising:
- providing a formulation comprising polymeric nanoparticles, wherein the polymeric nanoparticles comprise a therapeutic agent and a polymer selected from the group consisting of poly(lactic) acid-block-poly(ethylene)glycol copolymer and poly(lactic)-co-poly(glycolic) acid-block-poly(ethylene)glycol copolymer;
- adding hydroxypropyl β-cyclodextrin and mannitol to the formulation to form a pre-lyophilization aqueous formulation;
- and
- lyophilizing the pre-lyophilization aqueous formulation to form the lyophilized pharmaceutical formulation.
35-40. (canceled)
Dependencies are inferred from the claim text.