US 12,064,440 B2
Ophthalmic gel compositions of bimatoprost and timolol and associated methods
Mandar V. Shah, Rockaway, NJ (US); Veerappan Subramanian, Warren, NJ (US); Ilango Subramanian, Warren, NJ (US); and Aman Trehan, Hillsborough, NJ (US)
Assigned to Somerset Therapeutics, LLC, Hollywood, FL (US)
Filed by Somerset Therapeutics, LLC, Hollywood, FL (US)
Filed on Mar. 21, 2023, as Appl. No. 18/187,507.
Claims priority of provisional application 63/322,226, filed on Mar. 22, 2022.
Claims priority of provisional application 63/322,223, filed on Mar. 22, 2022.
Claims priority of provisional application 63/322,211, filed on Mar. 21, 2022.
Prior Publication US 2023/0338393 A1, Oct. 26, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/5575 (2006.01); A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 9/08 (2006.01); A61K 31/5377 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01)
CPC A61K 31/5575 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0048 (2013.01); A61K 9/06 (2013.01); A61K 9/08 (2013.01); A61K 31/5377 (2013.01); A61K 47/02 (2013.01); A61K 47/186 (2013.01)] 17 Claims
 
1. A pharmaceutically acceptable and ophthalmologically suitable composition in the form of a gel consisting of (1) 0.01% w/v of a bimatoprost compound; (2) about 0.4% w/v-about 0.8% w/v of a timolol compound; (3) about 0.005%-about 0.007% of benzalkonium chloride; (4) about 0.25% w/v-about 2.5% w/v of a penetration enhancer component wherein the penetration enhancer component comprises one or more compounds selected from the group consisting of a polyoxyethylene sorbitan fatty acid ester, a tocopheryl polyethylene glycol succinate, a polyoxyl hydrogenated castor oil, a poly-arginine, and a polyserine; and (5)about 0.1% w/v-about 1% w/v of a viscosity enhancing component, wherein the viscosity enhancing component is gellan gum, wherein the ratio of timolol compound to the viscosity enhancer component is about 10: about 1 to about 1: about 10 and the bimatoprost compound and the timolol compound are the only active pharmaceutical ingredients in the composition and wherein the gel have viscosity of less than about 75 cps after manufacture and while in storage at about 15° C.-about 27° C.