Claims for Patent: 9,186,413

Summary for Patent: 9,186,413

Title:	Sustained delivery formulations of risperidone compounds
Abstract:	The present invention relates to a risperidone sustained release delivery system for treatment of medical conditions relating delusional psychosis, schizophrenia, bipolar disorder, psychotic depression, obsessive-compulsion disorder, Tourette syndrome, and autistic spectrum disorders. The sustained release delivery system includes a flowable composition containing risperidone, a metabolite, or a prodrug thereof and an implant containing risperidone, a metabolite, or a prodrug thereof. The flowable composition may be injected into tissue whereupon it coagulates to become the solid or gel, monolithic implant. The flowable composition includes a biodegradable, thermoplastic polymer, an organic liquid, and risperidone, a metabolite, or a prodrug thereof.
Inventor(s):	Dadey; Eric (Furlong, PA)
Assignee:	Indivior UK Limited (Slough, GB)
Application Number:	14/490,082
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,186,413
Patent Claims:	1. A method for treating schizophrenia in a human in need thereof comprising administering a flowable composition to the human once per month by subcutaneous injection to treat the schizophrenia; wherein the flowable composition comprises: (a) about 15 wt % risperidone base in (b) about 45 wt % of an 80/20 poly(DL-lactide-co-glycolide) biodegradable thermoplastic polyester with a terminal carboxy group having an average molecular weight of about 10,000 Daltons to about 50,000 Daltons; and (c) about 55 wt % of N-methyl-2-pyrrolidone. 2. The method of claim 1, wherein the flowable composition transforms into a solid implant in situ after subcutaneous injection. 3. The method of claim 1, wherein the flowable composition produces maximum plasma concentration (C.sub.max) levels of risperidone in the human within about 6 hours of subcutaneous injection. 4. The method of claim 1, wherein the flowable composition produces maximum plasma concentration (C.sub.max) levels of risperidone in the human within about 2 hours of subcutaneous injection. 5. The method of claim 1, wherein the biodegradable thermoplastic polyester has an average molecular weight of about 15,000 Daltons to about 40,000 Daltons. 6. The method of claim 1, wherein the biodegradable thermoplastic polyester has a polydispersity index of about 1.4 to about 2.0. 7. A method for treating a mental impairment in a human in need thereof comprising administering a flowable composition to the human once per month by subcutaneous injection to treat the mental impairment; wherein the mental impairment is schizophrenia, bipolar disorder, psychotic depression, obsessive-compulsion disorder, Tourette's syndrome, or an autism spectrum disorder; and wherein the flowable composition comprises: (a) about 15 wt % risperidone base in (b) about 45 wt % of an 80/20 poly(DL-lactide-co-glycolide) biodegradable thermoplastic polyester with a terminal carboxy group having an average molecular weight of about 10,000 Daltons to about 50,000 Daltons; and (c) about 55 wt % of N-methyl-2-pyrrolidone. 8. The method of claim 7, wherein the flowable composition transforms into a solid implant in situ after subcutaneous injection. 9. The method of claim 7, wherein the flowable composition produces maximum plasma concentration (C.sub.max) levels of risperidone in the human within about 6 hours of subcutaneous injection. 10. The method of claim 7, wherein the flowable composition produces maximum plasma concentration (C.sub.max) levels of risperidone in the human within about 2 hours of subcutaneous injection. 11. The method of claim 7, wherein the biodegradable thermoplastic polyester has an average molecular weight of about 15,000 Daltons to about 40,000 Daltons. 12. The method of claim 7, wherein the biodegradable thermoplastic polyester has a polydispersity index of about 1.4 to about 2.0.