Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid

Patent metadata

Field	Value
Publication number	US-9566286-B2
Application number	US-201514707662-A
Country	US
Kind code	B2
Filing date	May 8, 2015
Priority date	Jun 11, 2010
Publication date	Feb 14, 2017
Grant date	Feb 14, 2017

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.

First claim

The invention claimed is:

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 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 3-5 alkane.

15. A container according to claim 14 , wherein the C 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 3-5 alkane 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).

Assignees

• Leo Pharma As

Inventors

• Lind Marianne
• Rasmussen Gritt
• Sonne Mette Rydahl
• Hansen Jens
• Petersson Karsten

Classifications

• A61P17/00

  Drugs for dermatological disorders · CPC title

• A61P17/02

  for treating wounds, ulcers, burns, scars, keloids, or the like · CPC title

• A61P17/08

  Antiseborrheics · CPC title

• A61P17/06

  Antipsoriatics · CPC title

• A61P17/10

  Anti-acne agents · CPC title