Gamma irradiation of solid nanoparticulate active agents
AssigneeElan Pharma International Limited
InventorsRobert Lee, Matthew Hilborn, Laura Kline, Janine Keller
Life of this patent
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Abstract
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.
Claims53
A method for terminal sterilization of a solid form of a nanoparticulate active agent composition comprising:
- (a) providing a solid form of at least one nanoparticulate active agent composition, wherein:
- (1) the nanoparticulate active agent composition comprises at least one active agent and at least one surface stabilizer;
- and
- (2) prior to formulation into a solid form the active agent has an effective average particle size of less than about 2 microns;
- and
- (b) subjecting the solid form to gamma irradiation;
- wherein said method produces a terminally sterilized solid form of at least one nanoparticulate active agent.
A terminally sterilized solid form of at least one nanoparticulate active agent comprising:
- (1) at least one active agent, wherein prior to formulation into a solid form the active agent has an effective average particle size of less than about 2 microns;
- and
- (2) at least one surface stabilizer;
- and
- wherein said solid form has been subjected to gamma irradiation sufficient to terminally sterilize the solid form.
Dependencies are inferred from the claim text.