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US 7,842,232 B2Granted
Sterilization of dispersions of nanoparticulate active agents with gamma radiation
AssigneeElan Pharma International Limited
InventorsH. William Bosch, Janine Keller
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Abstract
The present invention relates to methods for sterilization of dispersions of one or more nanoparticulate active agents via gamma irradiation.
Claims43
A method for sterilization of a liquid dispersion of one or more nanoparticulate active agents by:
- (a) providing a liquid dispersion of at least one nanoparticulate active agent, wherein the dispersion comprises:
- an aqueous liquid dispersion media;
- (ii) at least one active agent which is poorly soluble in the liquid dispersion media and which has an effective average particle size of less than about 1 micron, and
- (iii) at least one surface stabilizer associated with the surface of the active agent;
- and
- (b) subjecting the dispersion to gamma irradiation;
- wherein said method produces a sterilized dispersion of one or more nanoparticulate active agents containing a degradant concentration of not more than 0.2% w/w of the active agent.
4 more elements
A composition comprising a dispersion of one or more nanoparticulate active agents comprising:
- (a) an aqueous liquid dispersion media;
- (b) at least one active agent which is poorly soluble in the liquid dispersion media and which has an effective average particle size of less than about 1 micron, and
- (c) at least one surface stabilizer associated with the surface of the active agent;
- wherein the dispersion has been sterilized by subjecting the dispersion to gamma irradiation and
- wherein the dispersion contains a degradant concentration of not more than 0.2% w/w of the active agent.
2 more elements
A method of treating a mammal in need comprising administering a composition comprising a dispersion of one or more nanoparticulate active agents comprising:
- (a) an aqueous liquid dispersion media;
- (b) at least one active agent which is poorly soluble in the liquid dispersion media and which has an effective particle size of less than about 1 micron, and
- (c) at least one surface stabilizer associated with the surface of the active agent;
- wherein the dispersion has been sterilized by subjecting the dispersion to gamma irradiation and
- wherein the dispersion contains a degradant concentration of not more than 0.2% w/w of the active agent.
2 more elements
Dependencies are inferred from the claim text.