Topical pharmaceutical compositions for treating skin conditions
Topical pharmaceutical compositions for treating a skin condition or disorder are provided. The topical pharmaceutical compositions can be formulated as lotions containing a therapeutically effective amount of an active agent, such as tretinoin, a viscosity increasing agent, and advantageously small amounts of both a polymeric emulsifier and an oil component. The topical compositions of the present invention are tolerated exceptionally well by subjects to whom the compositions are administered.
1. A method for treating acne vulgaris in a subject, the method comprising applying once daily to an affected area of skin of the subject a topical pharmaceutical composition comprising:
tretinoin an active agent in an amount from 0.01% to 1% by weight of the composition;
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
water; and
wherein the composition is formulated as a lotion.
2. The method of claim 1 , wherein the pharmaceutical composition comprises the tretinoin in an amount of 0.05% by weight of the composition.
3. The method of claim 1 , wherein the polymeric emulsifier is a carbomer copolymer type B.
4. The method of claim 1 , wherein the oil component comprises mineral oil, light mineral oil, petrolatum, fatty alcohols, monocarboxylic acid esters, dicarboxylic acid esters, medium-chain triglycerides, long-chain triglycerides, or a combination thereof.
5. The method of claim 4 , wherein the oil component comprises mineral oil, light mineral oil, petrolatum, or a combination thereof.
6. The method of claim 1 , wherein the oil component consists of mineral oil.
7. The method of claim 1 , wherein the viscosity increasing agent is a carbomer homopolymer type A.
8. The method of claim 1 , wherein the viscosity increasing agent is present in an amount from 0.4% to 1% by weight of the composition.
9. The method of claim 8 , wherein the viscosity increasing agent is present in an amount from 0.6% to 1% by weight of the composition.
10. The method of claim 1 , wherein the composition has a viscosity from 2,500 cP to 18,000 cP.
11. The method of claim 10 , wherein the composition has a viscosity from 8,000 cP to 12,000 cP.
12. The method of claim 10 , wherein the composition further comprises one or more preservatives, antioxidants, and/or humectants.
13. The method of claim 10 , wherein the composition further comprises a neutralizing agent that maintains the pH of the composition at a pH from 5 to 6.
14. The method of claim 12 , wherein the pharmaceutical composition comprises:
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 one or more preservatives are benzyl alcohol, methyl paraben, or a combination thereof; and
optionally, a neutralizing agent, wherein the neutralizing agent is trolamine.