	US 11,931,328 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)
Filed by AMNEAL PHARMACEUTICALS LLC, Bridgewater, NJ (US)
Filed on Mar. 16, 2023, as Appl. No. 18/122,515.
Application 18/122,515 is a continuation of application No. 17/630,297, previously published as PCT/US2020/034840, filed on NaN, NaN.
Application 17/630,297 is a continuation of application No. 16/524,664, filed on Jul. 29, 2019, granted, now 10,792,262, issued on Oct. 6, 2020.
Prior Publication US 2023/0218554 A1, Jul. 13, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/197 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 9/20 (2006.01)

CPC A61K 31/197 (2013.01) [A61K 9/0095 (2013.01); A61K 9/1611 (2013.01); A61K 9/1617 (2013.01); A61K 9/1623 (2013.01); A61K 9/1635 (2013.01); A61K 9/1652 (2013.01); A61K 9/1664 (2013.01); A61K 9/1682 (2013.01); A61K 9/2013 (2013.01); A61K 9/2027 (2013.01)]

18 Claims

1. An immediate release pharmaceutical composition comprising granules comprising an active ingredient selected from 4-amino-3-(4-chlorophenyl) butanoic acid) (“baclofen”) and a pharmaceutically acceptable salt thereof; a stabilizer; and 4-(4-chlorophenyl)-2-pyrrolidone (4-CPP) impurity in an amount of less than 0.2 wt % of the active ingredient,

wherein the stabilizer is poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate),

wherein the impurity does not increase to more than 0.2 wt % after storage under accelerated storage conditions, and

wherein the accelerated storage conditions comprise storage of the composition for 6 months at 40° C. and 75% relative humidity (RH).