Patent ID: 9044388
Filing Date: 2015-06-02
Classification: A61K,A61P

Abstract:
1. A method for the formation of a meta stable oil in water emulsion able to withstand temperatures in excess of 75° C. without formation of a separate oil layer, the emulsion having an oil concentration of from 2.5 and 12.5 percent by weight and a maximum surfactant concentration of 2.5 percent by weight, said method comprising the steps of (1) selecting a first surfactant that (a) is approved for use on the ocular surface of the human eye, (b) enables formation of an emulsion having the above component concentration levels at physiological pH and is stable during storage, or capable of being reconstituted by simple shaking; and (c) enables formation of an emulsion which, when applied to the ocular surface, differentiates within a minute or less; (2) selecting a second surfactant that (a) is approved for use on the ocular surface of the eye, (b) is compatible with the remaining components of the emulsion; and (c) enables autoclaving at temperatures required to sterilize the emulsion but does not prevent breaking of the emulsion when applied to the ocular surface; and (3) mixing the components of the emulsion, including oil and water, to form the emulsion, said first surfactant being a polyoxyethylene ether selected from the group consisting of polyoxyethylene C 8-18 alkyl ethers, polyoxyethylene C 8-9 alkyl phenyl ethers, polyoxyethylene C 12-18 alkyl esters, polyoxyethylene C 12-18 alkyl amines, polyoxyethylene vegetable oil ethers, polyoxyethylene C 12-18 alkanol amides, and polyoxyethylene C 12-18 sorbitan ester ethers, and said second surfactant being a polyethoxylate selected from the group consisting of C 8 H 17 C 6 H 4 (OCH 2 CH 2 ) n OH where n is between 5 and 70, and C 9 H 19 C 6 H 4 (OCH 2 CH 2 ) p OH where p is between 5 and 40, and a polyoxyethylene C 12-22 alkyl ether.