Claims for Patent: 10,226,471

Summary for Patent: 10,226,471

Title:	Modified-release dosage forms of 5-HT.sub.2C agonists useful for weight management
Abstract:	The present invention relates to methods for weight management that utilize modified-release dosage forms comprising (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine salts and crystalline forms thereof. The present invention further relates to (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine salts, crystalline forms thereof and modified-release dosage forms comprising them.
Inventor(s):	Shao; Zezhi Jesse (San Diego, CA), Blackburn; Anthony C. (San Diego, CA), Grottick; Andrew J. (Chula Vista, CA), Morgan; Michael E. (San Diego, CA), Rueter; Jaimie Karyn (San Diego, CA), Shifrina; Anna (San Diego, CA), Stirn; Scott (San Diego, CA), Yang; Libo (San Diego, CA), Yoon; Woo Hyun (San Diego, CA)
Assignee:	Arena Pharmaceuticals, Inc. (San Diego, CA)
Application Number:	15/429,221
Patent Claims:	1. A modified-release dosage form which is a tablet for once-daily dosing, wherein the dosage form comprises a core tablet and a functional film coating, wherein said core tablet comprises: (i) about 7% by weight of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride salt hemihydrate, Form III, and (ii) about 50% by weight of (hydroxypropyl)methyl cellulose; wherein said functional film coating comprises ethyl cellulose and (hydroxypropyl)methyl cellulose in a weight ratio of about 85:15; and wherein said modified-release dosage form provides an in vitro release rate for which the time to achieve 80% release of said (R) 8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine (T80%) is at least 3 hours as determined by USP Apparatus I Basket Method in 900 mL of 0.1 N HCl solution at 37.degree. C. and 100 rpm. 2. The modified-release dosage form of claim 1, wherein the weight to weight ratio of said core tablet to said functional coating is about 20:1. 3. The modified-release dosage form of claim 1 or 2, wherein the core tablet further comprises microcrystalline cellulose. 4. The modified-release dosage form of claim 3, wherein the core tablet comprises about 20% by weight of microcrystalline cellulose. 5. The modified-release dosage form of claim 1 or 2, which exhibits a release profile comprising super-case II kinetics under in vitro conditions. 6. The modified-release dosage form according to claim 1 or 2, wherein the core tablet further comprises mannitol. 7. The modified-release dosage form according to claim 1 or 2, wherein the core tablet further comprises magnesium stearate.