Claims for Patent: 9,566,286

Summary for Patent: 9,566,286

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 or analog and a corticosteroid, and its use in the treatment of dermal diseases and conditions.
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:	14/707,662
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,566,286
Patent Claims:	1. A pressurized container adapted to dispensing a topical composition on an affected skin area, the container including a metal container body comprising a sprayable, storage stable, substantially anhydrous topical composition comprising a therapeutically effective amount of calcipotriol or calcipotriol monohydrate and a therapeutically effective amount of a betamethasone ester, said calcipotriol or calcipotriol monohydrate and betamethasone ester being dissolved in a pharmaceutically acceptable propellant selected from the group consisting of dimethyl ether or a propellant mixture comprising a first propellant selected from the group consisting of dimethyl ether and a second propellant selected from the group consisting of C.sub.3-5 alkanes, hydrofluoroalkanes, hydrochloroalkanes, fluoroalkanes and chlorofluoroalkanes, the composition further comprising a pharmaceutically acceptable lipid carrier solubilized or suspended in said propellant or propellant mixture, and a valve assembly including an actuator for releasing the composition as a spray, wherein the metal container body is lined with a chemically inert coating material selected from the group consisting of a polyimide-polyamide resin, a polyamide and a polyimide. 2. A container according to claim 1 which is composed of the metal container body in which said composition is stored, a dip tube, and the valve assembly comprising a valve cup, a valve body, and the actuator. 3. A container according to claim 2, wherein the container body is composed of a metal selected from the group consisting of stainless steel, tinplate and aluminium or aluminium alloy or anodised aluminium. 4. A container according to claim 3, wherein the container body is composed of aluminium or aluminium alloy. 5. A container according to claim 1, wherein the coating material is a polyimide-polyamide resin. 6. A container according to claim 1 further comprising gaskets or seals of chemically inert materials. 7. A container according to claim 6 comprising gaskets or seals of materials that are impermeable to the propellant or propellant mixture included in said composition. 8. A container according to claim 6, wherein the gaskets or seals are composed of materials selected from the group consisting of fluoroelastomers, fluorinated ethylene-propylene copolymer (FEP), fluororubber (FPM) or ethylene-propylene diene monomer rubber (EPDM). 9. A container according to claim 2, wherein the dip tube is composed of polyethylene or polypropylene. 10. A container according to claim 1, wherein the valve assembly is composed of a valve cup attached to the container body by crimping, a valve body which contains a valve stem and a spring connected to the actuator which is depressed for activation to expel the composition from the container. 11. A container according to claim 10, wherein the valve stem (contains at least one aperture with a diameter of 0.05-1 mm. 12. A container according to claim 10, wherein the actuator is provided with an insert having a terminal orifice with a diameter of 0.3-1.5 mm. 13. A container according to claim 1, wherein the betamethasone ester is betamethasone dipropionate or betamethasone valerate. 14. A container according to claim 1, wherein the second propellant of the propellant mixture is a C.sub.3-5 alkane. 15. A container according to claim 14, wherein the C.sub.3-5 alkane is selected from the group consisting of n-propane, isopropane, n-butane or isobutane. 16. A container according to claim 15, wherein the C.sub.3-5alkane is n-butane or isobutane. 17. A container according to claim 15, wherein the ratio of n-butane or isobutane to dimethyl ether is in the range of 6:1-0:1 v/v. 18. A container according to claim 14, wherein the ratio of n-butane and/or isobutane to dimethyl ether is in the range of 6:1-0:1 v/v. 19. A container according to claim 10, wherein the valve stem is composed of polyamide or acetal (POM).