AQUEOUS MEDICAMENT PREPARATIONS FOR THE PRODUCTION OF PROPELLENT GAS-FREE AEROSOLS

• US 20010008632A1
• Filed: 09/15/1999
• Published: 07/19/2001
• Est. Priority Date: 12/20/1996
• Status: Abandoned Application

• Current Assignee: Boehringer Ingelheim Pharmaceuticals Incorporated (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Pharmaceuticals Incorporated (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: ZIERENBERG, BERND, FREUND, BERNHARD
• Application Number:
  US09/331,023
• Publication Number:
  US 20010008632A1
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics

Abstract

The present invention relates to pharmaceutical preparations in the form of aqueous solutions for the production of propellant-free aerosols.

Claims

1. An aqueous pharmaceutical preparation in the form of a solution for the production of propellant-free aerosols for inhalation comprising a pharmacologically active ingredient, characterised in that the pharmaceutical preparation contains a complexing agent.

2. A pharmaceutical preparation according to

claim 1

, characterised in that the active ingredient is intended for application by inhalation, especially for the treatment of respiratory passage diseases.

3. A pharmaceutical preparation according to

claim 2

, characterised in that the active ingredient is selected from the group betamimetics, anticholinergics, antiallergics and/or antihistamines.

4. A pharmaceutical preparation according to claims 1, 2 or 3, characterised in that the active ingredient is selected from the group

Fenotrol, Ipatropium bromide, Berotec, Atrovent, Berodual, Salbutamol, Combivent, Ba 679 Br, BEA 2108 Br, Oxivent.

5. A pharmaceutical preparation according to any one of

claims 1

to

4

, characterised in that the complexing agent is nitrilotriacetic acid, citric acid, ascorbic acid or salts thereof.

6. A pharmaceutical preparation according to any one of

claims 1

to

4

, characterised in that the complexing agent is EDTA or a salt thereof.

7. A pharmaceutical preparation according to any one of

claims 1

to

6

, characterised in that the concentration of the complexing agent is between 10 and 100 mg/100 ml solution.

8. A pharmaceutical preparation according to

claim 7

characterised in that the concentration of the complex former is between 25 and 75 mg/100 ml solution.

9. A pharmaceutical preparation according to one of

claims 1

to

8

, characterised in that the adjuvant is a preservative.

10. A pharmaceutical preparation according to

claim 9

, characterised in that the preservative is Benzalkonium chloride.

11. A pharmaceutical preparation according to any one of the previous claims, characterised in that the pharmaceutical preparation contains up to 70% (by volume) ethanol.

12. A pharmaceutical preparation according to one of the previous claims, characterised in that it contains the active ingredient in a concentration of 0.001 to 2 g/100 ml solution.

13. A pharmaceutical preparation according to any one of the previous claims, characterised in that it contains pharmacologically acceptable adjuvant and flavouring substances.

14. The use of aqueous pharmaceutical preparations in the production of propellant-free aerosols for inhalation, characterised in that the pharmaceutical preparations contain a complexing agent.

15. The use according to

claim 14

, characterised in that the active ingredient is selected from the group Betamimetics, Anticholinergics, Antiallergics and/or antihistamines.

16. The use according to

claim 14

or

15

, characterised in that the active ingredient is selected from the group Fenotrol, Ipatropium bromide, Berotec, Atrovent, Berodual, Salbutamol, Combivent, Ba 679 Br, BEA 2108 Br, Oxivent.

17. The use according to any one of

claims 14

to

16

, characterised in that the complexing agent is nitriloacetic acid, citric acid, ascorbic acid or a salt thereof.

18. The use according to any one of

claims 14

to

16

, characterised in that the complexing agent is EDTA or a salt thereof.

19. The use according to

claim 18

, characterised in that the concentration of the complexing agent is between 25 and 75 mg.

20. The use according to any one of

claims 14

to

19

, characterised in that the pharmaceutical preparation contains up to 70% (by volume) ethanol.

21. The use according to any one of

claims 14

to

20

, characterised in that the pharmaceutical preparation contains active ingredient in a concentration of 0.001 to 2 g/100 ml solution.