US 11,654,124 B2
Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
David Penake, Atlanta, GA (US); Sharon Hamm, Odessa, FL (US); Leonard O'Mahony, Westmeath (IE); John Devane, Dublin (IE); Wolfgang Mohr, Freiburg (DE); and Manuel Weinheimer, Neustadt an der Weinstrasse (DE)
Assigned to AMNEAL PHARMACEUTICALS LLC, Bridgewater, NJ (US)
Appl. No. 17/630,297
Filed by AMNEAL PHARMACEUTICALS LLC, Bridgewater, NJ (US)
PCT Filed May 28, 2020, PCT No. PCT/US2020/034840
§ 371(c)(1), (2) Date Jan. 26, 2022,
PCT Pub. No. WO2021/021277, PCT Pub. Date Feb. 4, 2021.
Application 17/630,297 is a continuation in part of application No. 16/524,664, filed on Jul. 29, 2019, granted, now 10,792,262.
Prior Publication US 2022/0265588 A1, Aug. 25, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/197 (2006.01); A61K 9/20 (2006.01); A61K 9/16 (2006.01)
CPC A61K 31/197 (2013.01) [A61K 9/1611 (2013.01); A61K 9/1623 (2013.01); A61K 9/1635 (2013.01); A61K 9/1664 (2013.01); A61K 9/2027 (2013.01)] 13 Claims
 
1. An immediate release pharmaceutical composition, comprising an active ingredient selected from 4-amino-3-(4-chlorophenyl) butanoic acid) (“baclofen”) and a pharmaceutically acceptable salt thereof; and a stabilizer, wherein the stabilizer is a copolymer of poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate).