|Title:||Olopatadine formulations for topical administration|
|Abstract:||Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. The aqueous formulations contain approximately 0.17-0.62% (w/v) of olopatadine and an amount of polyvinylpyrrolidone or polystyrene sulfonic acid sufficient to enhance the physical stability of the formulations.|
|Inventor(s):|| Castillo; Ernesto J. (Arlington, TX), Han; Wesley Wehsin (Arlington, TX), Zhang; Huixiang (Fort Worth, TX), Bhagat; Haresh G. (Fort Worth, TX), Singh; Onkar N. (Arlington, TX), Bullock; Joseph Paul (Fort Worth, TX), Dixit; Suresh C. (Fort Worth, TX) |
|Assignee:|| Alcon, Inc. (Hunenberg, CH) |
1. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose, wherein the solution has a pH from 6.5-7.5 and a
viscosity of 1-2 cps, and wherein the solution consists essentially of: a) 0.18-0.22% (w/v) olopatadine; b) 1.5-2% (w/v) polyvinylpyrrolidone having a weight average molecular weight of 50,000-60,000; c) a preservative selected from the group
consisting of benzalkonium chloride; benzododecinum bromide; and polyquaternium-1; d) edetate disodium; e) a tonicity-adjusting agent selected from the group consisting of mannitol and sodium chloride; f) a buffering agent selected from the group
consisting of phosphates and borates; g) optionally a pH-adjusting agent selected from the group consisting of NaOH and HCl; and h) water.