A topical gel formulation for skin and mouth disorders and a process of preparation thereof

Abstract

The invention relates to a formulation of topical or oromucosal gel for the treatment of disorders of skin and mouth. The formulation comprises misoprostol 1% dispersion, mineral oil, PEG 400-Part I. PEG 400-Part II and PEG 3350. The invention discloses formulations of two gels comprising 100 ug/g of misoprostol drug corresponding to a concentration of 0.01% and 30 ug of misoprostol drug corresponding to a concentration of 0.003% respectively. The formulation is effective against oral mucositis. RAS, diabetes foot ulcers, decubitus ulcers and skin burns. The animal studies indicate reduction of oral mucositis upon administration of the drug along with decrease in levels of biomarkers IL-6 and TNF-α and the body weight has been significantly maintained which indicate the drug to be safe and effective.

Dependencies are inferred from the claim text.