Patent ID: 8449867
Filing Date: 2013-05-28
Classification: A61K,A61P,Y10S

Abstract:
1. A process for the preparation of an oil in water (O/W) microemulsion or sub-micron emulsion composition for dermal delivery of at least one pharmaceutically active ingredient, the method comprising the successive steps of: a) admixing a first part comprising at least one selected from the group consisting of an animal oil, a mineral oil, a vegetable oil, a silane, a siloxane, an ester, a fatty acid, a fat, a halogen compound, and an alkoxylated alcohol; and at least one lipophilic surfactant, and a second part comprising water and at least one hydrophilic surfactant to achieve homogeneity, b) heating the mix of step a) to a phase assembly temperature in the range of 40-99° C. with continuous mixing to obtain an oil in water microemulsion or sub-micron emulsion, c) allowing the microemulsion or sub-micron emulsion to cool, and d) adding a third part to the microemulsion or sub-micron emulsion at a temperature between 2° C. and the phase assembly temperature, the third part if necessary being premixed and heated until the components are dissolved and comprising a non-surfactant amphiphilic type compound, that is a water miscible organic solvent and a pharmaceutically active ingredient that is insoluble or only sparingly soluble in water, wherein the weight ratio of the at least one hydrophilic surfactant to the at least one lipophilic surfactant is approximately 9.0:1.0 to 2.0:3.0.