Claims for Patent: 11,311,482

Summary for Patent: 11,311,482

Title:	Topical compositions and methods for treating skin diseases
Abstract:	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.
Inventor(s):	Angel; Arturo (Santa Rosa, CA), Pillai; Radhakrishnan (Santa Rosa, CA)
Assignee:	BAUSCH HEALTH US, LLC (Bridgewater, NJ)
Application Number:	16/179,561
Patent Claims:	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 %.