Details for Patent: 6,200,549
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| 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. |
