Taro Pharmaceutical Industries Ltd.
TOPICAL MONTELUKAST FORMULATIONS

Abstract:

The present disclosure provides for topical emulsion comprising about 0.5% to about 10% Montelukast or pharmaceutically acceptable salt thereof; and about 0.4% to about 4% carbomer; wherein particles comprising the Montelukast in the emulsion have D90 of less than about 50 wherein the Montelukast or pharmaceutically acceptable salt thereof is homogeneously dispersed in the emulsion, and wherein the emulsion has a pH of about 3.0 to about 6.5. The present disclosure also provides a topical gel comprising (a) about 0.5% to about 10% Montelukast or pharmaceutically acceptable salt thereof; (b) about 0.2% to about 8% cellulose polymer; and (c) about 80% to about 95% amphiphilic compound; wherein the gel comprises less than 4% water.