Lyophilization Formulation Development Technology Transfer Clinical Development Glp Drug Delivery Gmp Pharmaceutical Development Validation Nanotechnology Product Development Process Development Formulation Lims Pharmaceutical Industry Regulatory Requirements Hplc Drug Development Sop Protein Chemistry Pharmaceutics Process Simulation
The present invention relates to methods for terminal sterilization of solid forms of nanoparticulate active agent compositions via gamma irradiation. The nanoparticulate active agent has an effective average particle size of less than about 2 microns, prior to incorporation into a solid form for sterilization. The resultant sterilized compositions exhibit excellent redispersibility, homogeneity, and uniformity. Also encompassed are compositions made via the described method and methods of treating animals and humans using such compositions.
Gamma Radiation Sterilized Nanoparticulate Docetaxel Compositions And Methods Of Making Same
H. William Bosch - Bryn Mawr PA, US Janine Keller - Collegeville PA, US Niels Ryde - Malvern PA, US
Assignee:
ELAN CORPORATION PLC - Dublin
International Classification:
A61K 9/14 A61K 31/337
US Classification:
424489, 514449
Abstract:
Nanoparticulate compositions comprising docetaxel or a salt, derivative, conjugate or analogue thereof, wherein the compositions are terminally sterilized via gamma radiation, are described, as well as methods of making and using such compositions.
Sterilization Of Dispersions Of Nanoparticulate Active Agents With Gamma Radiation