Topical pharmaceutical compositions for treating skin conditions

Abstract

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.

What is claimed is: 
     
         1 . A topical pharmaceutical composition for treating a skin condition or disorder, comprising:
 a therapeutically effective amount of an active agent that is useful for treating the skin condition or disorder;   a viscosity increasing agent;   a polymeric emulsifier, wherein the polymeric emulsifier is present in an amount ranging from about 0.01% to about 0.095% by weight of the composition; and   an oil component, wherein the oil component is present in an amount ranging from about 0.1% to about 5% by weight of the composition.   
     
     
         2 . The topical pharmaceutical composition of  claim 1 , wherein the active agent is a retinoid, a corticosteroid, an antibiotic, or an anti-inflammatory agent. 
     
     
         3 . The topical pharmaceutical composition of  claim 2 , wherein the active agent is a retinoid. 
     
     
         4 . The topical pharmaceutical composition of  claim 3 , wherein the retinoid is tretinoin. 
     
     
         5 . The topical pharmaceutical composition of any one of  claims 1  to  4 , wherein the active agent is present in an amount ranging from about 0.001% to about 1% by weight of the composition. 
     
     
         6 . The topical pharmaceutical composition of  claim 1 , comprising tretinoin in an amount of about 0.05% by weight of the composition. 
     
     
         7 . The topical pharmaceutical composition of any one of  claims 1  to  6 , wherein the polymeric emulsifier comprises a cross-linked copolymer of acrylic acid and C10-C30 alkyl acrylate. 
     
     
         8 . The topical pharmaceutical composition of any one of  claims 1  to  7 , wherein the polymeric emulsifier is present in an amount ranging from about 0.04% to about 0.06% by weight of the composition. 
     
     
         9 . The topical pharmaceutical composition of any one of  claims 1  to  8 , wherein the oil component comprises mineral oil. 
     
     
         10 . The topical pharmaceutical composition of any one of  claims 1  to  9 , wherein the oil component is present in an amount ranging from about 1% to about 3% by weight of the composition. 
     
     
         11 . The topical pharmaceutical composition of any one of  claims 1  to  10 , wherein the viscosity increasing agent comprises a cross-linked homopolymer of an acrylic acid. 
     
     
         12 . The topical pharmaceutical composition of any one of  claims 1  to  11 , wherein the viscosity increasing agent is present in an amount ranging from about 0.1% to about 2% by weight of the composition. 
     
     
         13 . The topical pharmaceutical composition of  claim 12 , wherein the viscosity increasing agent is present in an amount ranging from about 0.6% to about 1% by weight of the corn position. 
     
     
         14 . The topical pharmaceutical composition of any one of  claims 1  to  13 , further comprising one or more preservatives. 
     
     
         15 . The topical pharmaceutical composition of any one of  claims 1  to  14 , further comprising one or more moisturizing agents. 
     
     
         16 . The topical pharmaceutical composition of any one of  claims 1  to  15 , further comprising one or more antioxidants. 
     
     
         17 . The topical pharmaceutical composition of any one of  claims 1  to  16 , further comprising one or more humectants. 
     
     
         18 . The topical pharmaceutical composition of any one of  claims 1  to  17 , further comprising a neutralizing agent that maintains the pH of the composition at a pH from about 5 to about 6. 
     
     
         19 . The topical pharmaceutical composition of  claim 1 , comprising:
 tretinoin in an amount ranging from about 0.001% to about 1% by weight of the composition;   a viscosity increasing agent in an amount ranging from about 0.6% to about 1% by weight of the composition;   a polymeric emulsifier in an amount ranging om about 0.04% to about 0.06% by weight of the composition;   mineral oil in an amount ranging from about 1% to about 5% by weight of the composition;   one or more humectants, moisturizing agents, antioxidants, preservatives, wetting agents, and/or neutralizing agents; and   water.   
     
     
         20 . A topical pharmaceutical composition for treating a skin condition or disorder, comprising:
 tretinoin in an amount ranging from about 0.01% to about 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 ranging from to about 0.01% to about 0.095% by weight of the composition;   a viscosity increasing agent, wherein the viscosity increasing agent comprises a cross-linked homopolymer of an acrylic acid; and   an oil component, wherein the oil component is present in an amount ranging from about 0.1% to about 5% by weight.   
     
     
         21 . The topical pharmaceutical composition of  claim 20 , comprising tretinoin in an amount of about 0.05% by weight of the composition. 
     
     
         22 . The topical pharmaceutical composition of  claim 20  or  21 , wherein the polymeric emulsifier is a carbomer copolymer type B. 
     
     
         23 . The topical pharmaceutical composition of any one of  claims 20  to  22 , wherein the polymeric emulsifier is present in an amount ranging from about 0.04% to about 0.06% by weight of the composition. 
     
     
         24 . The topical pharmaceutical composition of a any one of  claims 20  to  23 , wherein the oil component comprises mineral oil. 
     
     
         25 . The topical pharmaceutical composition of any one of  claims 20  to  24 , wherein the oil component is present in an amount ranging from about 1% to about 3% by weight of the composition. 
     
     
         26 . The topical pharmaceutical composition of any one of  claims 20  to  25 , wherein the viscosity increasing agent is a carbomer homopolymer type A. 
     
     
         27 . The topical pharmaceutical composition of any one of  claims 20  to  26 , wherein the viscosity increasing agent is present in an amount ranging from about 0.1% to about 2% by weight of the composition. 
     
     
         28 . The topical pharmaceutical composition of  claim 27 , wherein the viscosity increasing agent is present in an amount ranging from about 0.6% to about 1% by weight of the composition. 
     
     
         29 . The topical pharmaceutical composition of any one of  claims 20  to  28 , further comprising one or more preservatives; moisturizing agents, antioxidants; and/or humectants. 
     
     
         30 . The topical pharmaceutical composition of any one of  claims 20  to  29 , further comprising a neutralizing agent that maintains the pH of the composition at a pH from about 5 to about 6. 
     
     
         31 . The topical pharmaceutical composition of  claim 20 , comprising:
 tretinoin in an amount of about 0.05% by weight of the composition;   a polymeric emulsifier in an amount ranging from about 0.04% to about 0.06% by weight of the composition, wherein the polymeric emulsifier is a carbomer copolymer type B;   a viscosity increasing agent in an amount ranging from about 0.6% to about 1% by weight of the composition; wherein the viscosity increasing agent is carbomer homopolymer type A;   an oil component in an amount ranging from about 0.1% to about 5% (e.g., from about 2% to about 4%, or from about 1% to about 3%) by weight of the composition, wherein the oil component is a mineral oil;   one or more moisturizing agents in an amount ranging from about 5% to about 20% by weight of the composition, wherein the moisturizing agents are sodium hyaluronate, soluble collagen, or a combination thereof;   a humectant in an amount ranging from about 5% to about 20% by weight of the composition, wherein the humectant is glycerin;   an antioxidant in an amount ranging from about 0.1% to about 2% by weight of the composition, wherein the antioxidant is butylated hydroxytoluene;   a wetting agent in an amount ranging from about 0.05% to about 0.5% by weight of the composition, wherein the wetting agent is octoxynol-9;   optionally, one or more preservatives in an amount ranging from about 0.25% to about 5% by weight of the composition, wherein the preservatives are benzyl alcohol, methyl paraben, or a combination thereof;   optionally, a neutralizing agent, wherein the neutralizing agent is trolamine; and   water.   
     
     
         32 . A topical pharmaceutical composition for treating a skin condition or disorder, wherein the topical pharmaceutical composition comprises:
 tretinoin in an amount of about 0.05% by weight of the composition;   a carbomer copolymer type B in an amount ranging from about 0.04% to about 0.06% by weight of the composition;   a carbomer homopolymer type A in an amount ranging from about 0.2% to about 1% by weight of the composition;   mineral oil in an amount ranging from about 2% to about 4% by weight of the composition;   one or more preservatives, moisturizing agents, antioxidants, humectants, wetting agents, and/or neutralizing agents; and   water.   
     
     
         33 . The topical pharmaceutical composition of any one of  claims 1  to  32 , wherein the composition has a viscosity from about 2,500 cP to about 18,000 cP. 
     
     
         34 . The topical pharmaceutical composition of any one of  claims 1  to  32 , wherein the composition has a viscosity of less than about 15,000 cP. 
     
     
         35 . The topical pharmaceutical composition of  claim 34 , wherein the composition has a viscosity from about 8,000 cP to about 12,000 cP. 
     
     
         36 . A kit comprising the topical pharmaceutical composition of any one of  claims 1  to  35 . 
     
     
         37 . A method for treating a skin condition or disorder, comprising administering the topical pharmaceutical composition of any one of  claims 1  to  35  to a subject in need thereof. 
     
     
         38 . The method of  claim 37 , wherein the skin condition or disorder is acne vulgaris. 
     
     
         39 . The method of  claim 37  or  38 , wherein the topical pharmaceutical composition is applied once daily to an affected area of skin. 
     
     
         40 . A method for treating acne vulgaris, the method comprising applying to the skin of a subject having acne vulgaris the topical pharmaceutical composition of any one of  claims 1  to  35 .