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US 9,872,848 B2Granted
Stable formulations for lyophilizing therapeutic particles
AssigneePfizer Inc.
InventorsGreg Troiano, Young-ho Song, Stephen E. Zale, James Wright, Christina Van Geen Hoven
Life of this patent
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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.
Claims17
A lyophilized pharmaceutical composition comprising:
- polymeric nanoparticles that comprises 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, wherein the polymeric nanoparticles have a diameter of about 60 nm to about 140 nm;
- a sugar;
- and
- hydroxypropyl β-cyclodextrin,
- wherein upon reconstitution of the lyophilized pharmaceutical composition in an aqueous medium, the reconstituted composition comprises 10-100 mg/mL concentration of the nanoparticles;
- 4 to 6 weight percent of the sugar;
- and 7 to 12 weight percent of the hydroxypropyl β-cyclodextrin, and wherein 100 mL of the reconstituted composition comprises less than 6000 microparticles of greater than or equal to 10 microns;
- and less than 600 microparticles of greater than or equal to 25 microns.
5 more elements
Dependencies are inferred from the claim text.