Combination of azelastine and ciclesonide for nasal administration

Patent metadata

Field	Value
Publication number	US-8933060-B2
Application number	US-201213644126-A
Country	US
Kind code	B2
Filing date	Oct 3, 2012
Priority date	Jun 14, 2002
Publication date	Jan 13, 2015
Grant date	Jan 13, 2015

Abstract

A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutical acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.

First claim

What is claimed is:

1. A method for the prophylaxis or treatment of rhinitis or conjunctivitis in a mammal, comprising intranasal administration to said mammal of a therapeutically effective amount of a pharmaceutical composition comprising (a) azelastine, or a pharmaceutically acceptable salt thereof; and (b) and ciclesonide, or a pharmaceutically acceptable salt or ester thereof.

2. The method of claim 1 , wherein the pharmaceutical composition comprises a dosage form suitable for nasal administration.

3. The method of claim 2 , wherein the dosage form suitable for nasal administration is in the form of an aerosol, an ointment, nasal drops, or a nasal spray or an inhalation solution.

4. The method of claim 2 , wherein the pharmaceutical composition is in the form of a nasal spray.

5. The method of claim 2 , wherein the pharmaceutical composition is in the form of nasal drops.

6. The method of claim 1 , wherein the pharmaceutical composition is in the form of an aqueous suspension or solution.

7. The method of claim 1 , wherein the pharmaceutical composition has a particle size of less than 10 μm.

8. The method of claim 1 , wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride.

9. The method of claim 1 , wherein the pharmaceutical composition further comprises at least one additive selected from the group consisting of a surfactant, an isotonic agent, a buffer, a preservative, and a suspending agent or a thickening agent, and combinations thereof.

10. The method of claim 9 , wherein the surfactant is selected from the group consisting of a polysorbate surfactant, a poloxamer surfactant, and combinations thereof.

11. The method of claim 9 , wherein the isotonic agent is selected from the group consisting of sodium chloride, saccharose, glucose, glycerine, sorbitol, 1,2-propylene glycol, and combinations thereof.

12. The method of claim 9 , wherein the buffer comprises a citric acid-citrate buffer.

13. The method of claim 9 , wherein the preservative is selected from the group consisting of edetic acid and its alkali salts, lower alkyl p-hydroxybenzoates, chlorhexidine, phenyl mercury borate, benzoic acid or a salt thereof, a quaternary ammonium compound, sorbic acid or a salt thereof, and combinations thereof.

14. The method of claim 9 , wherein the suspending agent or thickening agent is selected from the group consisting of cellulose derivatives, gelatin, polyvinylpyrrolidone, tragacanth, ethoxose, alginic acid, polyvinyl alcohol, polyacrylic acid, pectin, and combinations thereof.

15. The method of claim 9 , wherein the buffer, when present, maintains the pH of the aqueous phase at from 3 to 7.

16. The method of claim 1 , wherein the mammal is a human.

17. The method of claim 1 , wherein the method is prophylaxis or treatment of allergic rhinitis.

18. The method of claim 1 , wherein the method is prophylaxis or treatment of allergic conjunctivitis.

19. The method of claim 1 , wherein the pharmaceutical composition is formulated for use as a nasal spray or nasal drops in the treatment of seasonal allergic rhinitis or perennial allergic rhinitis.

20. The method of claim 1 , wherein the pharmaceutical composition is formulated for use as nasal spray or nasal drops in the treatment of seasonal allergic conjunctivitis or perennial allergic conjunctivitis.

21. The method of claim 8 , wherein the pharmaceutical composition is formulated for use as a nasal spray or nasal drops in the treatment of seasonal allergic rhinitis or perennial allergic rhinitis.

22. The method of claim 8 , wherein the pharmaceutical composition is formulated for use as nasal spray or nasal drops in the treatment of seasonal allergic conjunctivitis or perennial allergic conjunctivitis.

23. The method of claim 1 , wherein the method is prophylaxis or treatment of seasonal allergic rhinitis.

24. The method of claim 1 , wherein the method is prophylaxis or treatment of perennial allergic rhinitis.

25. The method of claim 1 , wherein the method is prophylaxis or treatment of seasonal allergic conjunctivitis,

26. The method of claim 1 , wherein the method is prophylaxis or treatment of perennial allergic conjunctivitis.

Assignees

• Cipla Ltd

Inventors

• Lulla Amar
• Malhotra Geena

Classifications

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61P27/00

  Drugs for disorders of the senses · CPC title

• A61P27/02

  Ophthalmic agents · CPC title

• A61P27/14

  Decongestants or antiallergics · CPC title