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 method of treating acne vulgaris, the method comprising topically applying a pharmaceutical composition once per day to an affected area of a body of a subject suffering from acne vulgaris, wherein:
the composition comprises tazarotene at a concentration of about 0.045 percent by weight of the composition as a sole active pharmaceutical ingredient
the composition is an oil-in-water emulsion lotion comprising an oil phase and an aqueous phase;
the oil phase comprises a dicarboxylic acid ester and a mineral oil at a total concentration of 10-12 percent by weight of the composition;
the aqueous phase comprises water and a carbomer homopolymer, wherein the concentration of the carbomer homopolymer is 0.5-0.7 percent by weight of the composition; and
the composition further comprises a polymeric emulsifier at a concentration of 0.3-0.5 percent by weight of the composition.
2. The method of claim 1 , wherein the dicarboxylic acid ester in the oil phase is diethyl sebacate.
3. The method of claim 1 , wherein the oil phase comprises diethyl sebacate and light mineral oil.
4. The method of claim 1 , wherein said applying is carried out for at least eight weeks.
5. The method of claim 1 , wherein said applying is carried out for at least twelve weeks.
6. The method of claim 1 , wherein said applying is carried out for twelve weeks.
7. The method of claim 1 , wherein the tazarotene is in solution in the oil phase of the oil-in-water emulsion lotion.
8. The method of claim 1 , wherein the composition has a pH of about 4 to about 6.
9. The method of claim 1 , wherein the composition consists essentially of:
0.045 weight % tazarotene;
diethyl sebacate;
light mineral oil;
sorbitan monooleate;
sorbitol solution, 70%;
methylparaben;
propylparaben;
edetate disodium dihydrate;
carbomer polymer type B;
carbomer homopolymer type A;
sodium hydroxide;
purified water.
10. The method of claim 1 , wherein the composition consists essentially of:
0.045 weight % tazarotene;
2.5-3.5 weight % diethyl sebacate;
7.5-8.5 weight % light mineral oil;
0.05-0.2 weight % sorbitan monooleate;
10-11 weight % sorbitol solution, 70%;
0.1-0.2 weight % methylparaben;
0.02-0.04 weight % propylparaben;
0.03-0.06 weight % edetate disodium dihydrate;
0.3-0.5 weight % carbomer polymer type B;
0.5-0.7 weight % carbomer homopolymer type A;
sodium hydroxide, q.s. to pH 5.5±0.5; and
purified water, q.s. to 100 weight %.
11. 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 consists essentially of:
0.045 weight % tazarotene;
2.97 weight % diethyl sebacate;
8.03 weight % light mineral oil;
0.1 weight % sorbitan monooleate;
10.7 weight % sorbitol solution, 70%;
0.17 weight % methylparaben;
0.03 weight % propylparaben;
0.05 weight % edetate disodium dihydrate;
0.4 weight % carbomer polymer type B;
0.6 weight % carbomer homopolymer type A;
sodium hydroxide, q.s. to pH 5.5±0.5; and
purified water, q.s. to 100 weight %.