ANHYDROUS COMPOSITIONS OF mTOR INHIBITORS AND METHODS OF USE
AssigneePalvella Therapeutics, Inc.
InventorsWesley Harton KAUPINEN, Braham SHROOT, Simon David BETSON, Charles Rodney GREENAWAY EVANS, Marc Barry BROWN
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Abstract
Disclosed herein are compositions and methods for topical delivery of mTOR inhibitors. In one embodiment, an anhydrous composition includes one or more mTOR inhibitors, one or more solvents, one or more gelling agents, and one or more antioxidants. Also disclosed herein are methods to treat skin disorders using such compositions.
Claims12
1-22. (canceled)
A method of treating diffuse microcystic lymphatic malformations in a subject in need thereof comprising topically administering to the affected areas of the subject an anhydrous gel composition, wherein the anhydrous gel composition comprises
- 2.5 wt % to about 4.5 wt % of rapamycin or a pharmaceutically acceptable salt thereof, based upon the total weight of the composition,
- about 80 wt % to about 97 wt % of a solvent, based upon the total weight of the composition, wherein the solvent is about 1 wt % to about 30 wt % diisopropyl adipate based upon the total weight of the composition, about 1 wt % to about 30 wt % glycerol based upon the total weight of the composition, about 40 wt % to about 60 wt % polyethylene glycol based upon the total weight of the composition, and about 1 wt % to about 30 wt % isopropyl alcohol, based upon the total weight of the composition,
- about 0.1 wt % to about 5 wt % of a gelling agent, based upon the total weight of the composition,
- about 0.001 wt % to about 1 wt % of an antioxidant, based upon the total weight of the composition, and
- optionally an additional pharmaceutically acceptable excipient,
- wherein a total weight of the composition is 100 wt %, and
- wherein the anhydrous gel composition has an apparent pH of about 4 to about 8.
Dependencies are inferred from the claim text.