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Claims for Patent: 5,972,919

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Claims for Patent: 5,972,919

Title: Combination of a bronchodilator and a steroidal anti-inflammatory drug for the treatment of respiratory disorders, as well as its use and the preparation thereof
Abstract:Effective amounts of formoterol (and/or a physiologically acceptable salt and/or solvate thereof) and budesonide are used in combination for simultaneous, sequential or separate administration by inhalation in the treatment of respiratory disorder.
Inventor(s): Carling; Christer Carl Gustav (Dalby, SE), Trofast; Jan William (Lund, SE)
Assignee: Astra Aktiebolag (Sodertalje, SE)
Application Number:08/944,683
Patent Claims: 1. A medicament containing as active ingredients effective amounts of a physiologically acceptable salt of formoterol or a solvate thereof, and budesonide wherein the molar ratio of the formoterol component to the budesonide component is in the range from 1:4 to 1:70.

2. A pharmaceutical composition which comprises effective amounts of a physiologically acceptable salt of formoterol or a solvate thereof, and budesonide wherein the molar ratio of the formoterol component to the budesonide component is in the range from 1:4 to 1:70, together with a pharmaceutically acceptable carrier.

3. A method for the treatment of asthma and other inflammatory respiratory disorders which comprises administering by inhalation to a host in need of such treatment effective amounts of a physiologically acceptable salt of formoterol or a solvate thereof, and budesonide wherein the molar ratio of the formoterol component to the budesonide component is in the range from 1:4 to 1.70.

4. The method according to claim 3, wherein the effective amount of the physiologically acceptable salt of formoterol or solvate thereof is 6-100 .mu.g per day, and the effective amount of budesonide is 50-4800 .mu.g per day.

5. The method according to claim 4 wherein the effective amount of the physiologically acceptable salt of formoterol or solvate thereof is 6-48 .mu.g per day, and the effective amount of budesonide is 100-1600 .mu.g per day.

6. The medicament of claim 1 wherein the active ingredients are in dry powder form.

7. The medicament of claim 1 or 6 wherein the formoterol is in the form of the fumarate dihydrate.

8. The pharmaceutical composition of claim 2 wherein the formoterol is in the form of the fumarate dihydrate.

9. The method according to any one of claims 3-5 wherein the administration is performed from a dry powder inhaler.

10. The method according to claim 9 wherein the inhaler is a Turbuhaler.RTM..

11. The method according to any one of claims 3-5 wherein the administration is performed from a metered dose inhaler.

12. The method according to any one of claims 3-5 wherein the formoterol is in the form of the fumarate dihydrate.

13. A pharmaceutical composition according to claim 2 wherein the pharmaceutically acceptable carrier is lactose.

14. A pharmaceutical composition according to claim 13 in dosage unit form.

15. The method according to any one of claims 3-5 wherein the administration is performed with a nebulizer.

16. The method according to any one of claims 3-5 wherein the formoterol component and the budesonide component are administered simultaneously.

17. The method according to any one of claims 3-5 wherein the formoterol component is administered in admixture with the budesonide component.

18. The method according to any one of claims 3-5 wherein the formoterol component and the budesonide component are administered sequentially.

19. The method according to any one of claims 3-5 wherein the formoterol component and the budesonide component are administered separately.
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