Claims for Patent: 10,653,656

Summary for Patent: 10,653,656

Title:	Topical pharmaceutical compositions for treating skin conditions
Abstract:	In one aspect, topical pharmaceutical compositions for treating a skin condition or disorder are provided. In some embodiments, the topical pharmaceutical composition is formulated as a lotion and comprises a therapeutically effective amount of an active agent; a viscosity increasing agent; a polymeric emulsifier; and an oil component. In some embodiments, the topical pharmaceutical composition comprises tretinoin.
Inventor(s):	Bhatt; Varsha (San Francisco, CA), Pillai; Radhakrishnan (Santa Rosa, CA)
Assignee:	Bausch Health Ireland Limited (Dublin, IE)
Application Number:	16/108,942
Patent Claims:	1. A topical pharmaceutical composition for treating a skin condition or disorder, comprising: an active agent in an amount from 0.01% to 1% by weight of the composition, wherein the active agent consists of tretinoin; a polymeric emulsifier, wherein the polymeric emulsifier comprises a cross-linked copolymer of acrylic acid and C10-C30 alkyl acrylate, and wherein the polymeric emulsifier is present in an amount from 0.02% to 0.08% by weight of the composition; a viscosity increasing agent, wherein the viscosity increasing agent comprises a cross-linked homopolymer of an acrylic acid, and wherein the viscosity increasing agent is present in an amount from 0.1% to 2% by weight of the composition; a moisturizing agent, wherein the moisturizing agent comprises soluble collagen and sodium hyaluronate, and wherein the moisturizing agent is present in an amount from 5% to 10% by weight of the composition; an oil component comprising one or more oils, wherein the oil component is present in an amount from 1% to 3.5% by weight of the composition, and wherein each oil in the oil component is independently selected from the group consisting of mineral oil, light mineral oil, petrolatum, fatty alcohols, monocarboxylic acid esters, dicarboxylic acid esters, medium-chain triglycerides, and long-chain triglycerides; and water; wherein the composition is formulated as a lotion. 2. The topical pharmaceutical composition of claim 1, comprising the tretinoin in an amount of 0.05% by weight of the composition. 3. The topical pharmaceutical composition of claim 1, wherein the polymeric emulsifier is a carbomer copolymer type B. 4. The topical pharmaceutical composition of claim 1, wherein the oil component consists of mineral oil, light mineral oil, petrolatum, or a combination thereof. 5. The topical pharmaceutical composition of claim 1, wherein the oil component consists of mineral oil. 6. The topical pharmaceutical composition of claim 1, wherein the viscosity increasing agent is a carbomer homopolymer type A. 7. The topical pharmaceutical composition of claim 1, wherein the viscosity increasing agent is present in an amount from 0.1% to 2% by weight of the composition. 8. The topical pharmaceutical composition of claim 7, wherein the viscosity increasing agent is present in an amount from 0.6% to 1% by weight of the composition. 9. The topical pharmaceutical composition of claim 1, wherein the composition has a viscosity from 2,500 cP to 18,000 cP. 10. The topical pharmaceutical composition of claim 9, wherein the composition has a viscosity from 8,000 cP to 12,000 cP. 11. The topical pharmaceutical composition of claim 1, further comprising one or more preservatives, antioxidants, and/or humectants. 12. The topical pharmaceutical composition of claim 1, further comprising a neutralizing agent that maintains the pH of the composition at a pH from 5 to 6. 13. The topical pharmaceutical composition of claim 1, comprising: the tretinoin in an amount of 0.05% by weight of the composition; the polymeric emulsifier in an amount of 0.05% by weight of the composition, wherein the polymeric emulsifier is a carbomer copolymer type B; the viscosity increasing agent in an amount from 0.6% to 1% by weight of the composition; wherein the viscosity increasing agent is carbomer homopolymer type A; the oil component in an amount up to 3% by weight of the composition, wherein the oil component consists of mineral oil; the moisturizing agent in an amount from 5% to 10% by weight of the composition; a humectant in an amount from 5% to 20% by weight of the composition, wherein the humectant is glycerin; an antioxidant in an amount from 0.1% to 2% by weight of the composition, wherein the antioxidant is butylated hydroxytoluene; a wetting agent in an amount from 0.05% to 0.5% by weight of the composition, wherein the wetting agent is octoxynol-9; optionally, one or more preservatives in an amount from 0.25% to 5% by weight of the composition, wherein the preservatives are benzyl alcohol, methyl paraben, or a combination thereof; and optionally, a neutralizing agent, wherein the neutralizing agent is trolamine. 14. The topical pharmaceutical composition of claim 1, wherein the composition has a viscosity of less than 15,000 cP. 15. The topical pharmaceutical composition of claim 14, wherein the composition has a viscosity from 8,000 cP to 12,000 cP. 16. A kit comprising the topical pharmaceutical composition of claim 1. 17. A method for treating a skin condition or disorder, comprising administering the topical pharmaceutical composition of claim 1 to a subject in need thereof. 18. The method of claim 17, wherein the skin condition or disorder is acne vulgaris. 19. The method of claim 17, wherein the topical pharmaceutical composition is applied once daily to an affected area of skin. 20. A topical pharmaceutical composition for treating a skin condition or disorder, wherein the topical pharmaceutical composition is formulated as a lotion and comprises: an active agent an amount of 0.05% by weight of the composition wherein the active agent consists of tretinoin; a carbomer copolymer type B in an amount from 0.04% to 0.06% by weight of the composition; a carbomer homopolymer type A in an amount from 0.2% to 1% by weight of the composition; soluble collagen and sodium hyaluronate in an amount from 5% to 10% by weight of the composition; an oil component in an amount up to 3.5% by weight of the composition, wherein the oil component consists of mineral oil; one or more preservatives, antioxidants, humectants, wetting agents, and/or neutralizing agents; and water. 21. A method for treating acne vulgaris, the method comprising applying to the skin of a subject having acne vulgaris the topical pharmaceutical composition of claim 20.