Composition for a topical ophthalmic clear colloidal liquid which undergoes a liquid-gel phase transition in the eye
View Patent ↗The present invention is directed to a topical ophthalmic composition for a liquid comprised of clear colloidal polar nanolipids delivered in submicron sized particles (Nanopids™), aqueous colloidal lubricants, aqueous polymers, emulsifies, and a unique stabilizing buffer system, which undergoes a liquid-gel phase transition in the eye. Said composition is designed to deliver advanced eye lubricants, protect the three (3) layers of corneal film from dryness, and provide a unique system of Dry Eye treatment that addresses and treats all three layers of corneal tear film. Said composition is further designed to provide a superior delivery system of various Active Pharmaceutical Ingredients (APIs), and/or anti-infective/antibiotic/anti-fungal agents, accepted as safe and efficacious for ophthalmic use.
1. An ophthalmic liquid adapted for the treatment of dry eye consisting essentially of water, colloidal oil droplets containing clear nano-size polar lipid which is nonionic polyoxyethylated castor oil or nonionic polyoxyethylated hydrogenated castor oil having a particle size of 1-50 nm, and gellan, which is buffered to a pH of 5-7.8, is free of cationic electrolytes, and has an osmolality of 250-400 mOsm/kg.H 2 O, said liquid being a clear liquid which forms a clear gel upon topical contact with the eye, and wherein said liquid is free of pharmaceutically acceptable active agent.
2. The ophthalmic liquid of claim 1 in which the composition is buffered to a pH of 6.8-7.8.
3. The ophthalmic liquid of claim 2 in which the polar lipid has a mean size of 9.8-16.2 nm, and the content of polar lipid is 0.1-15% w/v.