Topical naftifine compositions
OwnerHelena SHIFRIN, Alexandra SHRAIFEL +3inventors
InventorsHelena SHIFRIN, Alexandra SHRAIFEL, Ron SCHLINGER, Tzviel SHESKIN, Avi AVRAMOFF
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Abstract
The present disclosure provides a topical sprayable composition comprising: (a) about 0.05% to about 5% by weight naftifine or pharmaceutical acceptable salt thereof, (b) a film forming agent comprising octylacrylamide acrylate copolymer and, (c) an alcoholic solvent, topical spray composition wherein the ratio of the alcoholic solvent to the propellant in the composition is about 1:1 to about 3:1 (w/w). The disclosure also provides a method of treating a dermatophyte skin infection or onychomycosis in a subject in need thereof, the method comprising topically administering to the subject the topical compositions as described herein.
Claims40
A sprayable topical composition comprising:
- a. about 0.05% to about 5% by weight naftifine or pharmaceutical acceptable salt thereof,
- b. a film forming agent comprising octylacrylamide acrylate copolymer;
- c. an alcoholic solvent;
- and
- d. a propellant,
- wherein the ratio of the alcoholic solvent to propellant in the composition is about 1:1 to about 3:1 (w/w).
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A method of treating a dermatophyte skin infection in a subject, the method comprising administering a topical sprayable composition comprising naftifine, wherein the composition is a monophasic solution and the pharmaceutical is present in at least 80% saturation under conditions of use, wherein the administration of the topical composition to the subject results in a complete clearance of clinical signs and symptoms,
- wherein the complete clearance is characterized by achieving at least one of the scores for the clinical signs and symptoms listed in (a)-(c):
- (a) a decrease in severity of erythema from baseline with a score of 0 on day 42;
- (b) a decrease in severity of scaling from baseline with a score of 0 on day 42;
- (c) a decrease in severity of pruritus from baseline with a score of 0 on day 42;
- and by achieving mycological cure in a KOH test and in mycological culture.
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A drug-device combination for dispensing a composition, the drug-device combination comprising:
- a container comprising a composition comprising:
- i. naftifine or pharmaceutical acceptable salt thereof;
- ii. a film forming agent comprising octylacrylamide acrylate copolymer;
- iii. an alcoholic solvent;
- and
- iv. a propellant,
- wherein the drug-device combination is suitable for providing a spray comprising the composition, wherein the spray has a D90 droplet size greater than 1 μm.
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Dependencies are inferred from the claim text.