US 11,857,538 B2
Stable pilocarpine formulations with modified buffer characteristics and related 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 Jan. 13, 2023, as Appl. No. 18/154,524.
Claims priority of provisional application 63/299,883, filed on Jan. 14, 2022.
Claims priority of provisional application 63/299,870, filed on Jan. 14, 2022.
Claims priority of provisional application 63/299,877, filed on Jan. 14, 2022.
Prior Publication US 2023/0263775 A1, Aug. 24, 2023
Int. Cl. A61K 31/4178 (2006.01); A61K 9/08 (2006.01); A61K 9/00 (2006.01); A61K 47/18 (2017.01); A61K 47/36 (2006.01); A61K 47/26 (2006.01); A61K 9/06 (2006.01); A61K 47/12 (2006.01)
CPC A61K 31/4178 (2013.01) [A61K 9/0048 (2013.01); A61K 9/06 (2013.01); A61K 9/08 (2013.01); A61K 47/12 (2013.01); A61K 47/18 (2013.01); A61K 47/186 (2013.01); A61K 47/26 (2013.01); A61K 47/36 (2013.01)] 20 Claims
 
1. A pharmaceutically acceptable and ophthalmologically suitable reduced buffer content composition in the form of a solution for treating an ocular condition via administration to a mammalian eye, the reduced buffer content composition comprising an effective amount of a pilocarpine compound, wherein the effective amount of the pilocarpine compound is an amount greater than about 1% w/v of the composition and wherein the pilocarpine compound is the only active pharmaceutical ingredient present in the composition, and an effective amount of a uniform buffering component, wherein the uniform buffering component is present in a concentration such that the concentration of the pilocarpine compound in the composition is at least 1.5 times the concentration of the buffering component in the composition and the concentration of the pilocarpine compound in the composition is less than 4 times the concentration of the buffering component in the composition.