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Claims for Patent: 4,594,359

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Claims for Patent: 4,594,359

Title: Pharmaceutical compositions
Abstract:A pharmaceutical composition is described which contains as active ingredient the .beta.-stimulant salbutamol or one or more of its physiologically acceptable salts. The stability of aqueous formulations of the composition is improved by including a cellulose derivative which provide an optically transparent or opalescent colloidal dispersion. Preferred compositions are liquid formulations suitable for oral administration in which the cellulose derivative also serves as a thickening agent.
Inventor(s): Padfield; John M. (Meldreth, GB), Groom; Cheryl V. (Barnard Castle, GB)
Assignee: Glaxo Group Limited (London, GB2)
Application Number:06/593,432
Patent Claims: 1. A pharmaceutical composition comprising an aqueous dispersion of one or more cellulose derivatives containing salbutamol and/or one or more of its physiologically acceptable salts, wherein the cellulose derivative is an alkyl and/or hydroxyalkyl ether of cellulose; carboxymethyl cellulose or salts thereof; and wherein the amount of cellulose derivative present in the composition is a salbutamol stabilizing effective amount of said cellulose derivative.

2. A pharmaceutical composition according to claim 1, which comprises the one or more cellulose derivatives in a total amount of at least 0.1% w/v.

3. A pharmaceutical composition according to claim 1, wherein the cellulose derivative is an alkyl and/or hydroxyalkyl ether.

4. A pharmaceutical composition according to claim 1, in which the cellulose derivative is selected from the group consisting of ethyl cellulose, methyl cellulose, ethylmethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose, hydroxyethyl ethylcellulose, carboxymethylcellulose and salts of carboxymethylcellulose.

5. A pharmaceutical composition according to claim 4, wherein the cellulose derivative is hydroxypropyl methylcellulose.

6. A pharmaceutical composition according to claim 1, which is formulated as a liquid preparation suitable for oral administration.

7. A pharmaceutical composition according to claim 6, which contains the one or more cellulose derivatives in a total amount such as to provide the liquid preparation with a viscosity in the range of from 5 to 10,000 centipoises.

8. A pharmaceutical composition according to claim 7, wherein the viscosity is in the range of from 10 to 100 centipoises.

9. A pharmaceutical composition according to claim 6, which contains salbutamol and/or one or more of its physiologically acceptable salts in a concentration of 1 mg to 4 mg, expressed as salbutamol free base per 5 ml of liquid.

10. A pharmaceutical composition according to claim 9, wherein the concentration is 2 mg expressed as salbutamol free base per 5 ml of liquid.

11. A pharmaceutical composition according to claim 1, having a pH of 3.5.

12. A pharmaceutical composition according to claim 1 wherein the cellulose derivative is hydroxyethyl cellulose.

13. A pharmaceutical composition according to claim 1 which has a pH within the range of from 2.5 to 7.

14. A pharmaceutical composition according to claim 3 wherein the alkyl group and the alkyl moiety contain from 1 to 4 carbon atoms.
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