US 12,290,504 B2
Aqueous formulations of topiramate
Nilesh Parikh, Irvine, CA (US); William Hite, Winchester, CA (US); and Kartik Shah, Mumbai (IN)
Assigned to TaP Pharmaceuticals AG, Zug (CH)
Filed by TaP Pharmaceuticals AG, Baar (CH)
Filed on Apr. 11, 2023, as Appl. No. 18/133,349.
Prior Publication US 2024/0342132 A1, Oct. 17, 2024
Int. Cl. A61K 31/36 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/10 (2017.01)
CPC A61K 31/36 (2013.01) [A61K 9/0053 (2013.01); A61K 9/08 (2013.01); A61K 47/10 (2013.01)] 18 Claims
 
1. An aqueous pharmaceutical formulation, suitable for oral administration, comprising:
from 2% w/v to 7.5% w/v topiramate or a pharmaceutically acceptable salt thereof;
from 45% w/v to 75% w/v polyethylene glycol 400;
from 7.5% w/v to 12% w/v water; and
balance glycerol,
wherein the formulation exhibits a topiramate assay drop of 2% to 10% after six months at 40° C. and 75% relative humidity.