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Details for Patent: 6,306,369

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Details for Patent: 6,306,369

Title: Aerosol formulations containing P134a and particulate medicament
Abstract:A pharmaceutical formulation comprising (i) one or more particulate medicaments, and (ii) 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament, particulate medicament being present in an amount from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns, with the proviso that said medicament is other than salmeterol, salbutamol, fluticasone propionate, beclomethasone dipropionate or a physiologically acceptable salt or solvate thereof and with the proviso that when said formulation consists of betamethasone, ergotamine tartrate or sodium cromoglycate and 1,1,1,2-tetrafluoroethane the weight to weight ratio of medicament to propellant is other than 69:7900 or 0.866% w/w.
Inventor(s): Akehurst; Rachel Ann (Ware, GB), Taylor; Anthony James (Ware, GB), Wyatt; David Andrew (Ware, GB)
Assignee: Glaxo Group Limited (Greenford, GB)
Filing Date:Apr 28, 2000
Application Number:09/559,574
Claims:1. A pharmaceutical aerosol formulation comprising:

(a) an effective amount of a particulate bronchodilatory medicament;

(b) an effective amount of a particulate anti-inflammatory medicament; and

(c) 1,1,1,2-tetrafluoroethane as propellant;

which formulation contains less than 0.0001% surfactant by weight of the medicaments;

with the proviso that such medicaments are other than salmeterol, salbutamol, fluticasone propionate, beclomethasone dipropionate or a physiologically acceptable salt or solvate thereof, and wherein the particulate medicaments being present in an amount of 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

2. A pharmaceutical aerosol formulation according to claim 1 comprising:

(a) an effective amount of a particulate bronchodilatory medicament;

(b) an effective amount of a particulate anti-inflammatory medicament; and

(c) 1,1,1,2-tetrafluoroethane as propellant;

which formulation is free of surfactant.

3. A pharmaceutical aerosol formulation according to claim 1 wherein the bronchodilatory medicament is selected from the group consisting of ephedrine, epinephrine, fenoterol, formoterol, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, terbutaline, and (-)-4-amino-3,5-dichloro-.alpha.-[[[6-[2-(2-pyridinyl)ethoxy]hexyl]amino]- methyl]benzenemethanol and salts thereof.

4. A pharmaceutical aerosol formulation according to claim 3 wherein the bronchodilatory medicament is formoterol or a salt thereof.

5. A pharmaceutical aerosol formulation according to claim 1 wherein the bronchodilatory medicament is selected from the group consisting of isoetharine, tulobuterol, orciprenaline and salts thereof.

6. A pharmaceutical aerosol formulation according to claim 1 wherein the bronchodilatory medicament is an anti-cholinergic medicament.

7. A pharmaceutical aerosol formulation according to claim 6 wherein the anti-cholinergic medicament is ipratropium or a salt thereof.

8. A pharmaceutical aerosol formulation according to claim 1 wherein the anti-inflammatory medicament is an anti-allergic medicament.

9. A pharmaceutical aerosol formulation according to claim 8 wherein the anti-allergic medicament is sodium cromoglycate.

10. A pharmaceutical aerosol formulation according to claim 9 comprising sodium cromoglycate as anti-inflammatory medicament and isoprenaline as bronchodilatory medicament.

11. A pharmaceutical aerosol formulation according to claim 1 wherein the anti-inflammatory medicament is a steroidal anti-inflammatory medicament.

12. A pharmaceutical aerosol formulation according to claim 11 wherein the steroidal anti-inflammatory medicament is selected from the group consisting of flunisolide, tipredane and triamcinolone acetonide.

13. A pharmaceutical aerosol formulation according to claim 11 wherein the steroidal anti-inflammatory medicament is budesonide.

14. A pharmaceutical aerosol formulation according to claim 11 comprising (i) formoterol or a salt thereof as bronchodilatory medicament and (ii) budesonide as anti-inflammatory medicament.

15. A pharmaceutical aerosol formulation consisting essentially of:

(a) an effective amount of particulate formoterol or a salt thereof as bronchodilatory medicament;

(b) an effective amount of particulate budesonide as anti-inflammatory medicament; and

(c) 1,1,1,2-tetrafluoroethane as propellant;

which formulation contains less than 0.0001% surfactant by weight of the medicaments and wherein the particulate medicaments being present in an amount of 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

16. A pharmaceutical aerosol formulation consisting of:

(a) an effective amount of particulate formoterol or a salt thereof as bronchodilatory medicament;

(b) an effective amount of particulate budesonide as anti-inflammatory medicament; and

(c) 1,1,1,2-tetrafluoroethane as propellant and wherein the particulate medicaments being present in an amount of 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.

17. A pharmaceutical aerosol formulation according to claim 1 containing 0.01-1% w/w of medicament relative to the total weight of the formulation.

18. A method of treatment of respiratory disorders by inhalation therapy which comprises administering to a patient a pharmaceutical aerosol formulation according to claim 1.

19. A method of treatment of respiratory disorders by inhalation therapy which comprises administering to a patient a pharmaceutical aerosol formulation according to claim 14.

20. A method of treatment of respiratory disorders by inhalation therapy which comprises administering to a patient a pharmaceutical aerosol formulation according to claim 15.
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