Patent ID: 8298569
Filing Date: 2012-10-30
Classification: A61K,A61P

Abstract:
1. An ophthalmic oil-in-water emulsion, which comprises colloid particles having an oily core surrounded by an interfacial film, said emulsion comprising: 0.05 to 0.3% cyclosporine in weight to the total weight (w/w) of the emulsion, 0.5 to 4% w/w medium-chain triglycerides, 0.02% w/w benzalkonium chloride, and surfactants, wherein the surfactants consist of a mixture of tyloxapol and poloxamer, wherein the tyloxapol is present in an amount of 0.3% w/w and the poloxamer is present in an amount of 0.1% w/w, and wherein said emulsion is cationic, wherein said emulsion meets zeta potential stability under thermal stress conditions as determined by Test A: measuring zeta potential, in mV, of said emulsion at the time of preparation is Z sealing 5-10 ml of said emulsion in 10 ml Type I glass vials under nitrogen atmosphere without bubbling, storing said sealed vials at 80° C. for 7 days, measuring zeta potential, in mV, of said emulsion at 7 days, Z determining the difference between Z wherein said emulsion does not comprise phospholipids, and wherein said emulsion does not comprise substances capable of generating a negative charge.