US 11,911,515 B2
Extended release compositions comprising pyridostigmine
Siva Ram Kiran Vaka, Piscataway, NJ (US); Dipen Desai, Basking Ridge, 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 Apr. 20, 2023, as Appl. No. 18/136,916.
Application 18/136,916 is a continuation of application No. 17/550,117, filed on Dec. 14, 2021, granted, now 11,666,536.
Application 17/550,117 is a continuation of application No. 16/609,397, granted, now 11,229,606, issued on Jan. 25, 2022, 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 2023/0248656 A1, Aug. 10, 2023
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)] 20 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, and a gas generating agent,
wherein the permeable elastic membrane comprises a copolymer based on ethyl acrylate, methyl methacrylate, and trimethylammonioethyl methacrylate chloride,
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, and
wherein the dosage form floats in 40 minutes or less in about 200 ml of a dissolution medium comprising about 50 mM of pH 4.5 buffer and about 100 mM sodium chloride, measured using Rotating Bottle method at about 5 rpm and about 37° C.