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Claims for Patent: 9,119,781

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Claims for Patent: 9,119,781

Title:Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
Abstract: The present invention relates to a topical spray composition comprising a biologically active vitamin D derivative and a corticosteroid, and its use in the treatment of dermal diseases and conditions. The spray comprises especially a propellant selected from the group consisting of dimethyl ether, diethyl ether and methylethyl ether or a mixture thereof and further a pharmaceutically acceptable lipid carrier solubilised or suspended in said propellant.
Inventor(s): Lind; Marianne (Bagsv.ae butted.rd, DK), Rasmussen; Gritt (Virum, DK), Sonne; Mette Rydahl (Brondby Strand, DK), Hansen; Jens (Virum, DK), Petersson; Karsten (Ballerup, DK)
Assignee: LEO PHARMA A/S (Ballerup, DK)
Application Number:13/703,214
Patent Claims: 1. A sprayable, storage stable, substantially anhydrous topical composition comprising a therapeutically effective amount of about 0.00001-0.05% w/w of calcipotriol or calcipotriol monohydrate and a therapeutically effective amount of about 0.0005-1% of a betamethasone ester, the calcipotriol or calcipotriol monohydrate and the betamethasone ester being dissolved in a propellant comprising dimethyl ether or a mixture of dimethyl ether and one or more C.sub.3-5 alkanes, wherein the propellant is present in an amount of 50-90% w/w of the composition, the composition further comprising 0.1-10% of an oily co-solvent selected from the group consisting of polyoxypropylene-15-stearyl, ether, polyoxypropylene-11-stearyl ether, polyoxypropylene-14-butyl ether, and polyoxypropylene-10-cetyl ether or polyoxypropylene-3-myristyl ether; and 10-50% w/w of a pharmaceutically acceptable lipid carrier solubilized or suspended in said propellant, the lipid carrier comprising one or more paraffins which upon application on skin and evaporation of the propellant mixture form a semi-solid and occlusive layer at the site of application.

2. The composition according to claim 1, wherein the betamethasone ester is betamethasone dipropionate or betamethasone valerate.

3. The composition according to claim 1, wherein the C.sub.3-5alkane is n-butane and/or isobutane.

4. The composition according to claim 3, wherein the ratio of n-butane and/or isobutane to dimethyl ether is in the range of 6:1-0:1 v/v.

5. The composition according to claim 1 comprising 3-45% w/w of the lipid carrier.

6. The composition according to claim 1 comprising 55-70% w/w of the propellant.

7. The composition according to claim 1, comprising 0.5-3% w/w of the oily co-solvent.

8. The composition according to claim 1, wherein the paraffin is selected from paraffins consisting of hydrocarbons with chain lengths from C.sub.5 to C.sub.60, the chain lengths peaking at C.sub.14-16, C.sub.18-22, C.sub.20-22, C.sub.20-26, C.sub.28-40, and C.sub.40-44 as determined by gas chromatography.

9. A method of treating a dermatological diseases or condition, the method comprising administering to a patient in need thereof a therapeutically effective amount of a composition according to claim 1, wherein the dermatological disease or condition is selected from the group consisting of psoriasis, pustulosis palmoplantaris, ichtyosis, dermatitis, rosacea and acne.

10. The composition according to claim 1, wherein the C.sub.3-5 alkane is selected from the group consisting of n-propane, isopropane, n-butane, and isobutane.

11. The composition according to claim 8, further comprising a lipophilic viscosity-increasing agent capable of imparting to the lipid carrier the property of forming a semi-solid and occlusive layer on skin on application and evaporation of the propellant, said viscosity-increasing agent being selected from the group consisting of microcrystalline wax, silicone wax and hydrogenated castor oil, or mixtures thereof, and an isoparaffin.

12. The composition according to claim 4, wherein the ratio of n-butane and/or isobutane to dimethyl ether is in the range of 5:1-1:2 v/v.

13. The composition according to claim 4, wherein the ratio of n-butane and/or isobutane to dimethyl ether is in the range of 4:1-1:1 v/v.

14. The composition according to claim 4, wherein the ratio of n-butane and/or isobutane to dimethyl ether is in the range of 4:2-1:1 v/v.

15. The composition according to claim 4, wherein the ratio of n-butane and/or isobutane to dimethyl ether is in the range of 4:2-4:3 v/v.

16. The composition according to claim 1, comprising 1-2.5% w/w of the oily co-solvent.

17. The composition according to claim 1, comprising 1.5-2% w/w of the oily co-solvent.
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