Claims for Patent: 9,180,197

Summary for Patent: 9,180,197

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:	14/490,034
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,180,197
Patent Claims:	1. An injectable, flowable composition comprising (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 composition of claim 1, wherein the flowable composition is subcutaneously injectable. 3. The composition of claim 1, wherein the flowable composition transforms into a solid implant in situ after contact with water, body fluid, or other aqueous medium. 4. The composition of claim 1, wherein the flowable composition produces maximum plasma concentration (C.sub.max) levels of risperidone within about 6 hours after injection into a patient. 5. The composition of claim 1, wherein the flowable composition produces maximum plasma concentration (C.sub.max) levels of risperidone within about 2 hours after injection into a patient. 6. The composition of claim 1, wherein the biodegradable thermoplastic polyester has an average molecular weight of about 15,000 Daltons to about 40,000 Daltons. 7. The composition of claim 1, wherein the biodegradable thermoplastic polyester has a polydispersity index of about 1.4 to about 2.0.