Pharmaceutical composition for the treatment of rhinitis

• US 20050107330A1
• Filed: 11/08/2004
• Published: 05/19/2005
• Est. Priority Date: 11/13/2003
• Status: Abandoned Application

• Current Assignee: Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh
• Original Assignee: Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh
• Inventors: Greve, Harald, Greve, Rainer
• Application Number:
  US10/984,628
• Publication Number:
  US 20050107330A1
• Time in Patent Office: Days
• US Class Current: 514/54
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4174 Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to a pharmaceutical composition suitable for the prophylactic and/or curative topical treatment of rhinitis, said composition containing in combination and in each case in pharmaceutically efficacious amounts: (a) at least one sympathomimetic suitable for topical application and having vasoconstrictor action and/or detumescent action on the mucous membrane or its physiologically acceptable salts or derivatives; and (b) at least one preferably acidic glycosaminoglycan or its physiologically acceptable salts or derivatives, in particular hyaluronic acid or its salts. On account of a synergistic combined action of the glycosaminoglycan with the sympathomimetic, drying out and inflammatory irritation of the nasal mucous membranes caused by the sympathomimetic on topical application of the pharmaceutical composition are avoided and a detumescence of the mucous membrane in the nasal cavity and an inhibition of secretion are simultaneously achieved, which leads to an efficient alleviation of rhinitis.

Claims

1. A pharmaceutical composition for the prophylactic or curative topical treatment of rhinitis, said composition comprising in combination and in each case in pharmaceutically efficacious amounts:

(a) at least one sympathomimetic suitable for topical application and having vasoconstrictor action or detumescent action on the mucous membrane or its physiologically acceptable salts or derivatives; and

(b) at least one acidic glycosaminoglycan or its physiologically acceptable salts or derivatives.

2. The pharmaceutical composition according to claim 1, wherein the sympathomimetic is an α

-sympathomimetic having a 2-imidazoline structure and being selected from the group consisting of oxymetazoline, xylometazoline, tramazoline, tetryzoline and naphazoline, and their physiologically acceptable salts or derivatives.

3. The pharmaceutical composition according to claim 1, wherein the sympathomimetic is one of oxymetazoline hydrochloride or xylometazoline hydrochloride.

4. The pharmaceutical composition according to claim 1, wherein the sympathomimetic is present in amounts from 0.001 to 1% by weight, based on the pharmaceutical composition.

5. The pharmaceutical composition according to claim 1, wherein the glycosaminoglycan is hyaluronic acid or its physiologically acceptable salts.

6. The pharmaceutical composition according to claim 5, wherein the physiologically acceptable salt of the hyaluronic acid is the sodium salt of hyaluronic acid.

7. The pharmaceutical composition according to claim 1, wherein the glycosaminoglycan or its physiologically acceptable salts or derivatives is present in amounts from 0.01 to 5% by weight, based on the pharmaceutical composition.

8. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further contains (c) a compound selected from the group consisting of:

pantothenol, pantothenol ester, pantothenic acid and physiologically acceptable salts of pantothenic acid.

9. The pharmaceutical composition according to claim 8, wherein the pharmaceutical composition contains (c) the compound selected from the group consisting of:

pantothenol, pantothenol ester, pantothenic acid and physiologically acceptable salts of pantothenic acid in amounts altogether from 0.01 to 15% by weight, based on the pharmaceutical composition.

10. The pharmaceutical composition according to claim 8, wherein the pharmaceutical composition contains:

the components (a) and (b) in weight-related quantitative ratios of (a);

(b) in the range from 100;

1 to 1;

5,000;

the components (a) and (c) in weight-related quantitative ratios of (a);

(c) in the range from 100;

1 to 1;

15,000; and

the components (b) and (c) in weight-related quantitative ratios of (b);

(c) in the range from 500;

1 to 1;

1,500.

11. The pharmaceutical composition according to claim 1, wherein the composition is formulated as a solution, a dispersion a paste as a spray, an ointment, a cream or a gel.

19. A method of treating a human suffering from rhinitis, said method comprising administering an effective amount of the pharmaceutical composition as defined in claim 1 to said human.

12. A pharmaceutical composition for the prophylactic or curative topical treatment of rhinitis, said composition comprising in combination and in each case in pharmaceutically efficacious amounts:

(a) at least one sympathomimetic suitable for topical application and having vasoconstrictor action or detumescent action on the mucous membrane or its physiologically acceptable salts or derivatives;

(b) at least one acidic glycosaminoglycan or its physiologically acceptable salts or derivatives; and

(c) at least one of pantothenol, its derivatives, pantothenic acid, or physiologically acceptable salts of pantothenic acid.

13. The pharmaceutical composition according to claim 12, wherein the sympathomimetic is one of oxymetazoline hydrochloride or xylometazoline hydrochloride.

14. The pharmaceutical composition according to claim 12, wherein the glycosaminoglycan is hyaluronic acid or its physiologically acceptable salts.

20. A method of treating a human suffering from rhinitis, said method comprising administering an effective amount of the pharmaceutical composition as defined in claim 12 to said human.

15. A pharmaceutical composition for the prophylactic or curative topical treatment of rhinitis, said composition comprising in combination and in each case based on the pharmaceutical composition:

(a) 0.001 to 1% by weight of at least one sympathomimetic suitable for topical application and having vasoconstrictor action or detumescent action on the mucous membrane or its physiologically acceptable salts or derivatives;

(b) 0.01 to 5% by weight of at least one acidic glycosaminoglycan or its physiologically acceptable salts or derivatives; and

(c) optionally 0.01 to 15% by weight of pantothenol or its derivatives and/or pantothenic acid or its physiologically acceptable salts.

16. The pharmaceutical composition according to claim 15, wherein the sympathomimetic is one of oxymetazoline hydrochloride or xylometazoline hydrochloride.

17. The pharmaceutical composition according to claim 15, wherein the glycosaminoglycan is hyaluronic acid or its physiologically acceptable salts.

21. A method of treating a human suffering from rhinitis, said method comprising administering an effective amount of the pharmaceutical composition as defined in claim 15 to said human.

18. A pharmaceutical composition for the prophylactic or curative topical treatment of rhinitis, comprising in combination and in each case based on the pharmaceutical composition

(a) 0.001 to 1% by weight of at least one sympathomimetic selected from the group consisting of oxymetazoline and xylometazoline;

(b) 0.01 to 5% by weight of hyaluronic acid in the form of its physiologically acceptable salts; and

(c) optionally 0.01 to 15% by weight of at least one of pantothenol or its esters and/or pantothenic acid or its physiologically acceptable salts.

22. A method of treating a human suffering from rhinitis, said method comprising administering an effective amount of the pharmaceutical composition as defined in claim 18 to said human.