Pharmaceutical formulations containing corticosteroids for topical administration
Pharmaceutical compositions for topical application to skin are provided. In some embodiments, the pharmaceutical compositions comprise a corticosteroid and further comprise a liquid oil component comprising one or more dicarboxylic acid esters and/or monocarboxylic acid esters.
1. A pharmaceutical composition for topical application to the skin of an individual, the composition comprising:
a corticosteroid, wherein the corticosteroid is halobetasol propionate, and wherein the concentration of the corticosteroid is from about 0.01% w/w to about 0.03% w/w;
a liquid oil component, wherein the liquid oil component comprises one or more materials that are practically insoluble or insoluble in water and which are liquid at room temperature of 22° C., a dicarboxylic acid ester or a monocarboxylic ester, and a mineral oil or light mineral oil; and
an aqueous component;
wherein the pharmaceutical composition is formulated as a lotion, and
wherein the concentration of the liquid oil component is between 1.0 and 3.0 times that required to completely solubilize the corticosteroid in the composition at a temperature of 22° C.±2° C.
2. The pharmaceutical composition of claim 1 , wherein the concentration of the halobetasol propionate is about 0.01%.
3. The pharmaceutical composition of claim 1 , wherein the liquid oil component comprises a dicarboxylic acid ester.
4. The pharmaceutical composition of claim 1 , wherein the liquid oil component comprises a monocarboxylic acid ester.
5. The pharmaceutical composition of claim 1 , wherein the liquid oil component further comprises mineral oil or light mineral oil.
6. The pharmaceutical composition of claim 1 , wherein the concentration of the liquid oil component is sufficient to dissolve the corticosteroid in the composition at a temperature of 22° C.±2° C.
7. The pharmaceutical composition of claim 1 , wherein the concentration of the liquid oil component is between 1.0 and 1.5 times that required to completely solubilize the corticosteroid in the composition at a temperature of 22° C.±2° C.
8. The pharmaceutical composition of claim 1 , wherein the concentration of the liquid oil component is between 1.5 and 3 times that required to completely solubilize the corticosteroid in the composition at a temperature of 22° C.±2° C.
9. The pharmaceutical composition of claim 1 , wherein the composition further comprises one or more humectants, preservatives, chelating agents, emulsifying agents, and/or thickening agents.
10. The pharmaceutical composition of claim 9 , wherein the composition further comprises an emulsifying agent.
11. The pharmaceutical composition of claim 10 , wherein the emulsifying agent is sorbitan monooleate.
12. The pharmaceutical composition of claim 1 , wherein the composition further comprises a pH adjusting agent.
13. The pharmaceutical composition of claim 1 , wherein the composition maintains a VasoConstrictor Assay (VCA) score similar to the VCA score obtained by a formulation comprising 0.05% halobetasol propionate, cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, methylisothiazolinone, and water.
14. The pharmaceutical composition of claim 1 , wherein the composition provides an equivalent or better efficacy in treating a dermatological disorder compared to that provided by a formulation comprising-0.05% halobetasol propionate, cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, methylisothiazolinone, and water.
15. The pharmaceutical composition of claim 14 , wherein the dermatological disorder is psoriasis.