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Claims for Patent: 4,405,598

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Claims for Patent: 4,405,598

Title: Composition for treating asthma
Abstract:There is described a method of treatment of asthma which comprises administration to an asthmatic patient of an effective amount of an inhalation composition consisting essentially of a dispersion or suspension of from 0.2 to 2.0% disodium cromoglycate of mass median diameter 0.01 to 10 microns, from 0.15 to 2.0% by weight of a sorbitan or sorbitol ester surfactant and a propellant mixture comprising dichlorodifluoromethane and 1,2-dichloro-1,1,2,2-tetrafluoroethane, the ratio of dichlorodifluoromethane to 1,2-dichloro-1,1,2,2-tetrafluoroethane, in said mixture being in the range from 2:1 to 1:1 by weight, the disodium cromoglycate used in the formulation containing from 0.05 to 1% w/w of water and the total formulation containing less than 0.1% w/w of water and having a vapor pressure in the range 35 to 70 pounds per square inch gauge. There is also described disodium cromoglycate having a mass median diameter of less than 20 microns, more preferably in the range 0.01 to 10 microns, and most preferably at least 50% by weight of the particles having a diameter of 2 to 5 microns and containing less than 1% by weight of water.
Inventor(s): Brown; Kenneth (East Leake, GB2)
Assignee: Fisons, Limited (Ipswich, GB2)
Application Number:06/224,747
Patent Claims: 1. A method of treatment of asthma which comprises administration to an asthmatic patient of an effective amount of an inhalation composition comprising a dispersion or suspension of from 0.2 to 2.0% of disodium cromoglycate of mass median diameter 0.01 to 10 microns, from 0.15 to 2.0% by weight of a sorbitan or sorbitol ester surfactant and a propellant mixture comprising dichlorodifluoromethane and 1,2-dichloro-1,1,2,2-tetrafluoroethane and containing substantially no trichloromonofluoromethane, the ratio of dichlorodifluoromethane to 1,2-dichloro-1,1,2,2-tetrafluoroethane in said mixture being in the range from 2:1 to 1:1 by weight, the disodium cromoglycate used in the formulation containing from 0.05 to 1% w/w of water and the total formulation containing less than 0.1% w/w of water and having a vapour pressure in the range 35 to 70 pounds per square inch gauge.

2. A method according to claim 1, wherein at least 50% by weight of the particles of disodium cromoglycate have a diameter of 2 to 5 microns and containing from 0.2 to 1.2% by weight of surfactant.

3. An inhalation composition comprising a dispersion or suspension of from 0.2 to 2.0% disodium cromoglycate of mass median diameter 0.01 to 10 microns, from 0.15 to 2.0% by weight of a sorbitan or sorbitol ester surfactant and a propellant mixture consisting essentially of dichlorodifluoromethane and 1,2-dichloro-1,1,2,2-tetrafluoroethane, the ratio of dichlorodifluoromethane to 1,2-dichloro-1,1,2,2-tetrafluoroethane in said mixture being in the range from 2:1 to 1:1 by weight, the disodium cromoglycate used in the formulation containing from 0.05 to 1% w/w of water and the total formulation containing less than 0.1% w/w of water and having a vapour pressure in the range 35 to 70 pounds per square inch gauge.
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