Claims for Patent: 6,368,632

Summary for Patent: 6,368,632

Title:	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
Abstract:	Method of treating warm blooded animals suffering from psychotic disorders. The method includes administering a pharmaceutically effective amount of sustained-release microparticles that include risperidone, or a pharmaceutically acceptable acid addition salt thereof, and a biodegradable and biocompatible polymeric matrix.
Inventor(s):	Mesens; Jean (Wechelderzande, BE), Rickey; Michael E. (Loveland, OH), Atkins; Thomas J. (York, PA)
Assignee:	Janssen Pharmaceutica (Beerse, BE) Alkermes Controlled Therapeutics Inc. II (Cambridge, MA)
Application Number:	09/578,908
Patent Claims:	1. A method of treating warm blooded animals suffering from psychotic disorders comprising the administration thereto of a pharmaceutically effective amount of sustained-release microparticles produced by dissolving in a solvent an active agent and a biodegradable and biocompatible polymer to form an organic phase, wherein the active agent is selected from the group consisting of risperidone, 9-hydroxy-risperidone, and pharmaceutically acceptable acid addition salts of the foregoing, and extracting the solvent to form microparticles. 2. A method of treating warm blooded animals suffering from psychotic disorders comprising the administration thereto of a pharmaceutically effective amount of sustained-release microparticles comprising risperidone, or a pharmaceutically acceptable acid addition salt thereof, in crystalline form, and a biodegradable and biocompatible polymeric matrix. 3. The method of claim 1, wherein the microparticles range in size from 1 to 500 microns. 4. The method of claim 2, wherein the microparticles range in size from 1 to 500 microns. 5. The method of claim 1, wherein the microparticles range in size from 25 to 180 microns. 6. The method of claim 2, wherein the microparticles range in size from 25 to 180 microns. 7. The method of claim 1, wherein the microparticles are formulated in a liquid injection vehicle. 8. The method of claim 2, wherein the microparticles are formulated in a liquid injection vehicle. 9. The method of claim 7, wherein the liquid injection vehicle is selected from the group consisting of physiological saline solution and an aqueous solution of carboxymethyl cellulose with a surfactant. 10. The method of claim 8, wherein the liquid injection vehicle is selected from the group consisting of physiological saline solution and an aqueous solution of carboxymethyl cellulose with a surfactant. 11. The method of claim 1, wherein the microparticles are administered by intra-muscular injection. 12. The method of claim 2, wherein the microparticles are administered by intra-muscular injection. 13. The method of claim 1, wherein the microparticles are administered by subcutaneous injection. 14. The method of claim 2, wherein the microparticles are administered by subcutaneous injection. 15. The method of claim 3, wherein the microparticles comprise a plurality of sizes to provide for delivery of the active agent in a multi-phasic manner. 16. The method of claim 4, wherein the microparticles comprise a plurality of sizes to provide for delivery of the active agent in a multi-phasic manner. 17. The method of claim 1, wherein a portion of the microparticles exhibit diffusional release and a portion of the microparticles exhibit biodegradation release. 18. The method of claim 2, wherein a portion of the microparticles exhibit diffusional release and a portion of the microparticles exhibit biodegradation release. 19. The method of claim 17, wherein a portion of the microparticles exhibit both diffusional release and biodegradation release. 20. The method of claim 18, wherein a portion of the microparticles exhibit both diffusional release and biodegradation release.