US 11,666,536 B2
Extended release compositions comprising pyridostigmine
Siva Ram Kiran Vaka, Piscataway, NJ (US); Dipen Desai, Whippany, NJ (US); Wantanee Phuapradit, Lewes, DE (US); Navnit H. Shah, Monmouth Junction, NJ (US); and Namdev B. Shelke, Hillsborough, NJ (US)
Assigned to Amneal Complex Products Research LLC, Bridgewater, NJ (US)
Filed by AMNEAL COMPLEX PRODUCTS RESEARCH LLC, Bridgewater, NJ (US)
Filed on Dec. 14, 2021, as Appl. No. 17/550,117.
Application 17/550,117 is a continuation of application No. 16/609,397, previously published as PCT/US2019/037795, filed on Jun. 18, 2019.
Claims priority of provisional application 62/725,024, filed on Aug. 30, 2018.
Claims priority of provisional application 62/826,402, filed on Mar. 29, 2019.
Prior Publication US 2022/0096386 A1, Mar. 31, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/28 (2006.01); A61K 9/50 (2006.01); A61K 31/4425 (2006.01)
CPC A61K 9/2886 (2013.01) [A61K 9/5042 (2013.01); A61K 9/5073 (2013.01); A61K 31/4425 (2013.01); A61K 9/2866 (2013.01)] 34 Claims
 
1. A gastroretentive dosage form comprising a core, and a permeable elastic membrane comprising at least one orifice and surrounding the core,
wherein the core comprises pyridostigmine or a pharmaceutically acceptable salt thereof, a gas-generating agent, and a swellable water-soluble hydrophilic polymer,
wherein the permeable elastic membrane comprises a copolymer based on ethyl acrylate, methyl methacrylate, and trimethylammonioethyl methacrylate chloride, and
wherein the copolymer is present in an amount of from about 70 wt % to about 95 wt %, based on the total weight of the membrane.