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Details for Patent: 6,200,549

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Details for Patent: 6,200,549

Title: Aerosol formulation 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:Mar 09, 1999
Application Number:09/264,665
Claims:1. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting essentially of one or more particulate medicaments and 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.

2. A method as claimed in claim 1 wherein the formulation is free of surfactant.

3. A method as claimed in claim 1 wherein said medicament is an anti-allergic, a bronchodilator or an anti-inflammatory steroid.

4. A method as claimed in claim 1 wherein said medicament is a bronchodilator.

5. A method as claimed in claim 1 wherein said medicament is ephedrine, adrenaline, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, rimiterol, terbutaline, or (-)-4-amino-3,5-dichloro-.alpha.-[[[6-[2-(2-pyridinyl)ethoxy]hexyl]-amino] methyl]benzenemethanol or a physiologically acceptable salt thereof.

6. A method as claimed in claim 1 wherein said medicament is formoterol or a physiologically acceptable salt thereof.

7. A method as claimed in claim 1 wherein said medicament is fenoterol, reproterol, isoetharine, tulobuterol, or a physiologically acceptable salt thereof.

8. A method as claimed in claim 1 wherein said medicament is an anti-allergic medicament selected from the group consisting of ketotifen, nedocromil and physiologically acceptable salts thereof.

9. A method as claimed in claim 1 wherein said medicament is anti-allergic medicament selected from the group consisting of budesonide, triamcinolone acetonide, and physiologically acceptable salts thereof.

10. A method as claimed in claim 1 wherein said medicament is an anti-cholinergic medicament selected from the group consisting of ipratropium, atropine, oxitropium and physiologically acceptable salts thereof.

11. A method as claimed in claim 1 wherein said medicament is a xanthine selected from the group consisting of aminophylline, choline theophyllinate, lysine theophyllinate, theophylline and physiologically acceptable salts thereof.

12. A method as claimed in claim 1 wherein said medicament is an anti-inflammatory medicament which is flunisolide.

13. A method as claimed in claim 1 wherein said medicament is cromoglycate or a physiologically acceptable salt thereof.

14. A method as claimed in claim 1 in which the formulation contains two or more particulate medicaments.

15. A method as claimed in claim 1 wherein the formulation comprises a particulate bronchodilatory medicament and a particulate anti-inflammatory medicament.

16. A method as claimed in claim 1 wherein the formulation comprises isoprenaline and cromoglycate or a physiologically acceptable salt thereof.

17. A method as claimed in claim 1 wherein the formulation contains 0.01 to 1% w/w of medicament relative to the total weight of the formulation.

18. A method as claimed in claim 1 wherein the formulation has a respirable fraction of 20% or more by weight of medicament.

19. A method as claimed in claim 1 wherein said medicament is pirbuterol or a physiologically acceptable salt thereof.

20. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation consisting of (i) one or more particulate medicaments, and (ii) 1,1,1,2-tetrafluoroethane as propellant, the 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, wherein said one of the one or more medicaments is a bronchodilator selected from the group consisting of ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, terbutaline, isoetharine, tulobuterol, orciprenaline or (-)-4-amino-3,5-dichloro-.alpha.-[[[6-[2-(2-pyridinyl)ethoxy]hexyl]-amino] methyl]benzenemethanol or a physiologically acceptable salt thereof.

21. A method as claimed in claim 20 wherein said medicament is pirbuterol or a physiologically acceptable salt thereof.

22. A method as claimed in claim 20 wherein the formulation contains two or more particulate medicaments.

23. A method as claimed in claim 20 wherein the formulation comprises a particulate bronchodilatory medicament and a particulate anti-inflammatory medicament.

24. A method as claimed in claim 20 wherein the formulation comprises a particulate bronchodilatory medicament and a particulate anti-allergic medicament.

25. A method as claimed in claim 20 wherein the formulation comprises isoprenaline and cromoglycate or a physiologically acceptable salt thereof.

26. A method as claimed in claim 20 wherein the formulation contains 0.01 to 1% w/w of medicament relative to the total weight of the formulation.

27. A method as claimed in claim 20 wherein the formulation has a respirable fraction of 20% or more by weight of medicament.
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