Controlled release nanoparticulate clozapine compositions
AssigneeElan Pharma International Limited
InventorsJon Swanson, Rajeev A. Jain, Robert Hontz, John G. Devane, Kenneth Iain Cumming, Maurice Joseph Anthony Clancy, Janet Elizabeth Codd, Gary Liversidge
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Abstract
Described are controlled release nanoparticulate formulations comprising a nanoparticulate agent to be administered and a rate-controlling polymer which functions to prolong the release of the agent following administration. The novel compositions release the agent following administration for a time period ranging from about 2 to about 24 hours or longer.
Claims35
A controlled release nanoparticulate clozapine composition comprising:
- (a) clozapine particles having an effective average particle size of less than about 1000 nm;
- (b) at least one surface stabilizer adsorbed on the surface of the clozapine particles, wherein the surface stabilizer is free of intermolecular cross-linkages, and
- (c) at least one pharmaceutically acceptable rate-controlling polymer, wherein the composition provides controlled release of clozapine for a time period ranging from about 2 to about 24 hours.
A method of preparing a solid dose controlled release nanoparticulate clozapine formulation comprising:
- (a) combining a nanoparticulate clozapine composition having an effective average particle size of less than about 1000 nm and at least one surface stabilizer adsorbed on the surface of the nanoparticulate clozapine particles with at least one suitable rate-controlling polymer, wherein the surface stabilizer is free of intermolecular cross-linkages;
- and
- (b) forming a solid dose of the mixture from step (a), wherein the solid dose releases the nanoparticulate clozapine following oral administration to a patient for a time period ranging from about 2 to about 24 hours.
A method of treating a mammal comprising:
- (a) administering to the mammal an effective amount of a solid dose controlled release nanoparticulate clozapine composition comprising
- particles of clozapine having an effective average particle size of less than about 1000 nm and at least one surface stabilizer adsorbed on the surface of the clozapine particles, wherein the surface stabilizer is free of intermolecular cross-linkages;
- and
- (b) releasing the clozapine particles to the mammal following administration for a time period ranging from about 2 to about 24 hours.
Dependencies are inferred from the claim text.