Claims
- 1. A pharmaceutical aerosol formulation which comprises:
- (a) beclomethasone dipropionate monohydrate, the particle size of substantially all the monohydrate being less than 20 microns;
- (b) at least 0.015% by weight of the formulation of water in addition to the water of crystallisation associated with said monohydrate whereby said at least 0.015% water stabilizes the particle size of said beclomethasone dipropionate monohydrate particles;
- (c) a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant.
- 2. A pharmaceutical aerosol formulation consisting essentially of particulate beclomethasone dipropionate monohydrate, at least 0.015% by weight of water and one or more fluorocarbon or hydrogen-containing chlorofluorocarbon propellant.
- 3. A formulation as claimed in claim 1 which comprises 0.015to 0.1% by weight of added water.
- 4. A formulation as claimed in claim 1 which comprises at least 0.026% by weight of added water.
- 5. A formulation as claimed in claim 1 which comprises 0.026% to 0.08% by weight of added water.
- 6. A formulation as claimed in claim 1 wherein the propellant comprises a C.sub.1-4 hydrogen-containing fluorocarbon.
- 7. A formulation as claimed in claim 6 wherein the propellant comprises 1,1,1,2,3,3,3-heptafluoro-n-propane.
- 8. A formulation as claimed in claim 6 wherein the propellant comprises 1,1,1,2-tetrafluoroethane.
- 9. A formulation as claimed in claim 1 which comprises 0.03 to 0.08% by weight of added water and 1,1,1,2-tetrafluoroethane as propellant.
- 10. A formulation as claimed in claim 1 which comprises 0.02 to 0.05% by weight of added water and 1,1,1,2,3,3,3-heptafluoro-n-propane as propellant.
- 11. A formulation as claimed in claim 1 wherein the beclomethasone dipropionate monohydrate is present in an amount of 0.005 to 10% w/w based on the total weight of the formulation.
- 12. A formulation as claimed in claim 1 which contains one or more additional active ingredients.
- 13. A formulation as claimed in claim 12 which comprises salmetermol or salbutamol or a physiologically acceptable salt thereof in combination with beclomethasone dipropionate monohydrate.
- 14. A formulation as claimed in claim 13 which comprises salbutamol and beclomethasone dipropionate monohydrate.
- 15. A formulation as claimed in claim 13 which comprises salmeterol xinafoate and beclomethasone dipropionate monohydrate.
- 16. A formulation as claimed in claim 1 which has a respirable fraction of 20% or more by weight of the medicament.
- 17. A process for preparing a pharmaceutical aerosol formulation as claimed in claim 1 which comprises dispersing the medicament and added water in propellant.
- 18. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation which comprises:
- (a) beclomethasone dipropionate monohydrate, the particle size of substantially all the monohydrate being less than 20 microns;
- (b) at least 0.015% by weight of the formulation of water in addition to the water of crystallisation associated with said monohydrate whereby said at least 0.015% water stabilizes the particle size of said beclomethasone dipropionate monohydrate particles;
- (c) a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant.
Priority Claims (1)
Number |
Date |
Country |
Kind |
92 02519 |
Feb 1992 |
GBX |
|
Parent Case Info
This application is a division of application Ser. No. 08/256,294, filed Jul. 12, 1994, which is a 371 of PCT/EP93/00223, filed on Feb. 2, 1993.
US Referenced Citations (3)
Foreign Referenced Citations (3)
Number |
Date |
Country |
A-2 076 422 |
Dec 1981 |
GBX |
A-2 107 715 |
May 1983 |
GBX |
WO-A-92 06675 |
Apr 1992 |
WOX |
Divisions (1)
|
Number |
Date |
Country |
Parent |
256294 |
Jul 1994 |
|