US 12,257,255 B1
Timolol maleate gel for topical administration
Enxian Lu, East Brunswick, NJ (US)
Assigned to AUSON PHARMACEUTICALS INC., Bridgewater, NJ (US)
Filed by Auson Pharmaceuticals, Inc., Bridgewater, NJ (US)
Filed on Jan. 23, 2024, as Appl. No. 18/420,370.
Int. Cl. A61K 31/5377 (2006.01); A61K 9/00 (2006.01); A61P 9/14 (2006.01)
CPC A61K 31/5377 (2013.01) [A61K 9/0014 (2013.01); A61P 9/14 (2018.01)] 10 Claims
 
1. A method of providing a steady state mean timolol blood Cmax,ss less than 150 pg/mL in a human subject in need thereof, comprising administering topically to the subject a formulation comprising timolol maleate at a daily dose of timolol ranging from about 0.5 to about 8 mg/cm2/day, wherein the formulation is configured and the amount of the timolol maleate in the formulation is selected so that at steady state a ratio of Cmax,SS/Cmin,SS is less than 2, wherein the formulation comprises timolol maleate, propylene glycol in an amount of about 6% by weight, carbomer in an amount of about 1.8% by weight, triethanolamine in an amount of about 0.8% by weight, and ethyl hydroxybenzoate in an amount of about 0.1% by weight, and water.