Claims for Patent: 10,682,364

Summary for Patent: 10,682,364

Title:	Pharmaceutical spray composition comprising a vitamind D analogue and a corticosteroid
Abstract:	The present invention relates to a topical spray composition comprising a biologically active vitamin D derivative or analogue and a corticosteroid, and its use in the treatment of dermal diseases and conditions.
Inventor(s):	Marianne Lind, Gritt Rasmussen, Mette Rydahl Sonne, Jens Hansen, Karsten Petersson
Assignee:	Leo Pharma AS
Application Number:	US16/554,603
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,682,364
Patent Claims:	1. A sprayable, substantially anhydrous topical composition comprising calcipotriol or calcipotriol monohydrate, betamethasone dipropionate, a pharmaceutically acceptable propellant, present in amount between 45-95% w/w of the total composition, a pharmaceutically acceptable lipid carrier, present in an amount between 5-55% w/w of the total composition, and a pharmaceutically acceptable antioxidant, wherein the composition does not include propylene glycol, and wherein no more than 10% by weight of the calcipotriol or calcipotriol monohydrate has degraded after storage of the composition for 3 months at about 40° C. 2. The composition of claim 1, wherein no more than 6% by weight of the calcipotriol or calcipotriol monohydrate has degraded after storage of the composition for 3 months at about 40° C. 3. The composition of claim 1, wherein each gram of the composition, excluding any mass contributed by any pharmaceutically acceptable propellant, comprises 52.2 mcg of calcipotriol monohydrate and 0.643 mg betamethasone dipropionate. 4. The composition of claim 3, wherein the composition further comprises a pharmaceutically acceptable lipophilic viscosity increasing ingredient. 5. The composition of claim 1, wherein the pharmaceutically acceptable propellant comprises a C3-5 alkane. 6. The composition of claim 5, wherein the C3-5 alkane is propane, isopropane, n-butane, isobutane, or mixtures thereof. 7. The composition of claim 6, wherein the C3-5 alkane is n-butane. 8. The composition of claim 3, wherein the pharmaceutically acceptable propellant comprises dimethyl ether. 9. The composition of claim 1, wherein the pharmaceutically acceptable lipid carrier comprises petrolatum. 10. The composition of claim 9, wherein the composition further comprises a pharmaceutically acceptable oily cosolvent. 11. The composition of claim 1, wherein each gram of the composition, excluding any mass contributed by any pharmaceutically acceptable propellant, comprises 52.2 mcg of calcipotriol monohydrate and 0.643 mg betamethasone dipropionate, and wherein the pharmaceutically acceptable lipid carrier comprises petrolatum, and wherein the composition further comprises a pharmaceutically acceptable oily cosolvent. 12. The composition of claim 10, wherein the oily co-solvent comprises a compound of general formula I: H(OCH2C(CH3)H)xOR1 wherein R1 is a straight or branched chain C1-20 alkyl, and x is an integer from 2 to 60 inclusive. 13. The composition of claim 12, wherein the compound of general formula I is polyoxypropylene-15-stearyl ether, polyoxypropylene-11-stearyl ether, polyoxypropylene-14-butyl ether, polyoxypropylene-10-cetyl ether, or polyoxypropylene-3-myristyl ether. 14. The composition of claim 10, wherein the oily co-solvent comprises an isopropyl ester of a straight or branched chain C10-18 alkanoic or alkenoic acid. 15. The composition of claim 14, wherein the isopropyl ester of a straight or branched chain C10-18 alkanoic or alkenoic acid is isopropyl myristate, isopropyl palmitate, isopropyl isostearate, isopropyl linolate, or isopropyl monooleate. 16. The composition of claim 10, wherein the oily co-solvent comprises a straight or branched C8-24 alkanol or alkenol. 17. The composition of claim 16, wherein (i) the straight C8-24 alkanol is capryl alcohol, lauryl alcohol, cetyl alcohol, stearyl alcohol, or myristyl alcohol, (ii) the straight C8-24 alkenol is oleyl alcohol or linoleyl alcohol, and/or (iii) the branched C8-24 alkanol is a branched C18-24 alkanol. 18. The composition of claim 17, wherein the straight C8-24 alkanol is myristyl alcohol. 19. The composition of claim 9, wherein (a) the calcipotriol or calcipotriol monohydrate is present in an amount between 0.001-0.05% w/w of the total composition, (b) the betamethasone dipropionate is present in an amount between 0.0005-1% w/w of the total composition, and (c) a pharmaceutically acceptable oily co-solvent, which is present in an amount between 0.1-10% w/w of the total composition. 20. The composition of claim 19, wherein the composition comprises calcipotriol, wherein (a) the calcipotriol is present in an amount of 0.005% w/w of the composition, excluding any mass contributed by any pharmaceutically acceptable propellant , and (b) the betamethasone dipropionate is present in an amount of 0.064% w/w of the composition, excluding any mass contributed by any pharmaceutically acceptable propellant. 21. The composition of claim 19, wherein the composition comprises calcipotriol monohydrate, wherein (a) the calcipotriol monohydrate is present in an amount of 0.00522% w/w of the composition, excluding any mass contributed by any pharmaceutically acceptable propellant, and (b) the betamethasone dipropionate is present in an amount of 0.064% w/w of the composition, excluding any mass contributed by any pharmaceutically acceptable propellant. 22. The composition of claim 21 wherein the pharmaceutically acceptable oily co-solvent is myristyl alcohol. 23. The composition of claim 3, wherein the pharmaceutically acceptable propellant comprises dimethyl ether; the pharmaceutically acceptable lipid carrier is a mixture of liquid paraffin and petrolatum. 24. The composition of claim 23, further comprising a pharmaceutically acceptable oily co-solvent. 25. The composition of claim 9, wherein the petrolatum is white soft paraffin. 26. The composition of claim 11, wherein the petrolatum is white soft paraffin. 27. The composition of claim 23, wherein the petrolatum is white soft paraffin.