Medicaments
AssigneeSmithKline Beecham Corporation
InventorsMichael Thomas Riebe, Sarvajna Kumar Dwivedi, Li Li-Bovet
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Abstract
This invention relates to aerosol formulations of use for the administration of medicaments by inhalation. More particularly, the invention relates to a pharmaceutical aerosol formulation which comprises particulate salbutamol sulphate having a crystalline form in which the outer layer of the crystals is substantially non-amorphous; and 1,1,1,2-tetrafluoroethane. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as defined is also described.
Claims20
A process of forming a pharmaceutical aerosol formulation, said process comprising:
- subjecting particulate salbutamol sulphate to a temperature of between about 0° C. and about 100° C. with a relative humidity of between about 20% to about 90% to form annealed particulate salbutamol sulphate;
- and
- combining the annealed salbutamol sulphate with a propellant comprising 1, 1, 1, 2-tetrafluoroethane to form a pharmaceutical aerosol formulation.
A process of forming a pharmaceutical aerosol formulation, said process comprising:
- subjecting particulate salbutamol sulphate to elevated temperatures under vacuum to form annealed particulate salbutamol sulphate;
- and
- combining the annealed salbutamol sulphate with a propellant comprising 1, 1, 1, 2-tetrafluoroethane to form a pharmaceutical aerosol formulation.
The process according to claim 20, wherein said annealed particulate salbutamol sulphate has a water content of less than about 0.35% by weight.
Dependencies are inferred from the claim text.