US Patent No. 9,498,443

STABLE FORMULATIONS FOR LYOPHILIZING THERAPEUTIC PARTICLES


Patent No. 9,498,443
Issue Date November 22, 2016
Title Stable Formulations For Lyophilizing Therapeutic Particles
Inventorship Greg Troiano, Pembroke, MA (US)
Young-Ho Song, Natick, MA (US)
Stephen E. Zale, Hopkinton, MA (US)
James Wright, Lexington, MA (US)
Christina Van Geen Hoven, Cambridge, MA (US)
Assignee Pfizer Inc., New York, NY (US)

Claim of US Patent No. 9,498,443

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 ?-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 ?-cyclodextrin.