Topical pharmaceutical compositions comprising etodolac

A topical gel comprising

• (a) nano sized droplets comprising about 0.5% to about 3.0% w/w of etodolac or a salt thereof;
• (b) optionally nano sized droplets comprising about 12.0% to about 18.0% w/w of methyl salicylate or a salt thereof;
• (c) about 3.0% to about 7.0% w/w of alcohol;
• (d) about 0.1% to about 10.0% w/w of emulsifiers;
• (e) about 5% to about 25% w/w of oil/lipids;
• (f) one or more pH adjusting agents;
• and
• (g) water.

A process for the preparation of a stable topical pharmaceutical composition comprising etodolac or salts thereof, and one or more pharmaceutically acceptable excipients comprising one or more of lipids, oils, emulsifiers, initiators, pH adjusting agents, thickening agents, emollients, humectants, preservatives, and chelating agents, the process comprising:

• a) combining an oily phase comprising one or more etodolac or salts thereof along with other pharmaceutically acceptable excipients with an aqueous phase to form an emulsion;
• b) reducing the particle size of emulsion of step a) to a droplet size having a particle size (D90) of about 500 nm or less;
• and
• c) mixing the other pharmaceutically acceptable excipients to the emulsion obtained in step b) and converting it into a suitable finished dosage form.