Topical pharmaceutical formulation
The present disclosure provides pharmaceutical compositions comprising mometasone and diisopropyl adipate (DIPA) for topical administration. These compositions can be formulated as creams, lotions, and foams, and are particularly suitable for administration in hairy skin; for example, for treating inflammatory skin conditions, such as dermatitis, eczema, and psoriasis.
1. A pharmaceutical composition for topical administration comprising an oil phase, said oil phase comprising mometasone furoate and diisopropyl adipate, wherein the composition comprises from about 0.05 to about 0.1 wt. % of mometasone furoate fully dissolved in the oil phase comprising at least 20 wt. % of diisopropyl adipate based on the weight of the oil phase and at least one triglyceride oil, and wherein the weight ratio of the diisopropyl adipate to the triglyceride oil is from 30:70 to 70:30, wherein the oil phase is free of paraffin and the water phase is free of polyalcohols.
2. The pharmaceutical composition according to claim 1 , wherein the triglyceride oil is selected from medium-chain triglycerides, castor oil, and combinations thereof.
3. The pharmaceutical composition according to claim 1 , wherein the composition is in the form of a liquid or semisolid o/w-emulsion.
4. The pharmaceutical composition according to claim 3 , wherein the oil phase represents from 25% to 50% of the weight of the composition.
5. The pharmaceutical composition according to claim 3 , wherein the emulsion is foamed.
6. The pharmaceutical composition according to claim 3 , wherein the semisolid o/w emulsion is a lotion, and wherein the emulsion comprises a thickener selected from xanthan, hydroxy ethyl cellulose, polyacrylate carbomer, carboxymethylcellulose sodium or calcium, methyl cellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, alginate, sodium alginate or combinations thereof.
7. The pharmaceutical composition according to claim 6 , wherein the lotion is pourable and exhibits a shear viscosity in the range from 0.1 to 0.5 Pa*s at 100/s.
8. The pharmaceutical composition according to claim 3 , wherein the semisolid o/w emulsion is a cream emulsion comprises a, and wherein the thickener is selected from carbomers and water-soluble cellulose ethers.
9. The pharmaceutical composition according to claim 1 , wherein the oil phase is free of paraffin and/or the water phase is free of polyalcohols.
10. The pharmaceutical composition according to claim 1 , wherein the composition comprises at least one nonionic surfactant.
11. The pharmaceutical composition according to claim 1 , wherein the composition is in the form of an oil-in-water (o/w) emulsion and comprises from about 0.05 to about 0.1 wt. % of mometasone furoate fully dissolved in the oil phase comprising at least 20 wt. % of diisopropyl adipate and at least one triglyceride oil, wherein the weight ratio of the diisopropyl adipate to the triglyceride oil(s) is from about 30:70 to 70:30, and wherein the oil phase represents from about 25% to 50% of the oil-in-water (o/w) emulsion.
12. A method of treatment of a subject suffering from a dermatological disease or condition that is responsive to topical glucocorticoid therapy, wherein the dermatological disease or condition is selected from atopic dermatitis, atopic eczema, psoriasis, vitiligo, lichen sclerosus, or scalp psoriasis the method comprising administering the pharmaceutical composition according to claim 1 to the subject.