TOPICAL COMPOSITIONS AND METHODS FOR TREATING SKIN DISEASES
Topical pharmaceutical compositions include tazarotene or a pharmaceutically acceptable salt of tazarotenic acid and an oil-in-water emulsion vehicle that forms a lotion. The compositions are used to treat skin diseases, such as acne vulgaris.
1 . A topical pharmaceutical composition for treating a skin disease, comprising:
tazarotene or a pharmaceutically acceptable tazarotenic acid salt present in the composition at a concentration in the range from about 0.01 to 0.049 percent by weight of the composition; and
a dermatologically acceptable oil-in-water emulsion vehicle; wherein said composition is a lotion.
2 . The topical pharmaceutical composition of claim 1 , comprising tazarotene at a concentration from about 0.03 to 0.049 percent by weight of the composition.
3 . The topical pharmaceutical composition of claim 1 , comprising tazarotene at a concentration of about 0.045 percent by weight of the composition.
4 . The topical pharmaceutical composition of claim 1 , wherein the tazarotene or tazarotenic acid salt is dissolved in a liquid oil component of the emulsion.
5 . The topical pharmaceutical composition of claim 1 , containing the tazarotene or the tazarotenic acid salt as a sole active pharmaceutical ingredient.
6 . The topical pharmaceutical composition of claim 1 , wherein an oil phase of the emulsion comprises a liquid oil component comprising a dicarboxylic acid ester (“DCAE”), a monocarboxylic acid ester (“MCAE”), or combinations thereof.
7 . The topical pharmaceutical composition of claim 1 , wherein an oil phase of the emulsion comprises diethyl sebacate.
8 . The topical pharmaceutical composition of claim 1 , wherein an aqueous phase of the emulsion comprises water and a carbomer homopolymer.
9 . The topical pharmaceutical composition of claim 1 , wherein an aqueous phase comprises water, a carbomer homopolymer, and a polymeric emulsifier; and
wherein an oil phase comprises at least one member selected from the group consisting of a dicarboxylic acid ester and a mineral oil.
10 . The topical pharmaceutical composition of claim 1 , wherein the oil phase comprises diethyl sebacate and mineral oil.
11 . The topical pharmaceutical composition of claim 1 , wherein the oil phase consists of diethyl sebacate and mineral oil.
12 . The topical pharmaceutical composition of claim 1 , having a pH of about 4 to about 6.
13 . A method of treating acne vulgaris, the method comprising topically applying a pharmaceutical composition to an affected area of a body of a subject suffering from acne vulgaris; wherein the composition comprises:
tazarotene or a pharmaceutically acceptable tazarotenic acid salt present in the composition at a concentration from about 0.01 to 0.049 percent by weight of the composition; and
a dermatologically acceptable oil-in-water emulsion vehicle; wherein said composition is a lotion.
14 . The method of claim 13 , comprising tazarotene at a concentration from about 0.03 to 0.049 percent by weight of the composition.
15 . The method of claim 13 , comprising tazarotene at a concentration of about 0.045 percent by weight of the composition.
16 . The method of claim 13 , wherein said emulsion comprises:
an aqueous phase comprising water, a carbomer homopolymer, and a polymeric emulsifier; and
an oil phase comprising at least one member selected from the group consisting of a dicarboxylic acid ester and a mineral oil.
17 . The method of claim 16 , wherein the oil phase of the emulsion comprises diethyl sebacate.
18 . The method of claim 13 , wherein the oil phase of the emulsion comprises diethyl sebacate and mineral oil.
19 . The method of claim 13 , wherein the oil phase of the emulsion consists of diethyl sebacate and mineral oil.
20 . The method of claim 13 , wherein said applying is carried out once per day for at least eight weeks.
21 . The method of claim 13 , wherein said applying is carried out once per day for at least twelve weeks.
22 . The method of claim 13 , wherein said applying is carried out once per day for twelve weeks.
23 . The method of claim 13 , wherein the pharmaceutical composition contains the tazarotene or the tazarotenic acid salt as a sole active pharmaceutical ingredient.