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Last Updated: April 25, 2024

Claims for Patent: 5,068,249

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Summary for Patent: 5,068,249

Title:	Aqueous ranitidine compositions stabilized with ethanol
Abstract:	The stability of aqueous formulations of ranitidine or a physiologically acceptable salt thereof is enhanced by the addition of ethanol.
Inventor(s):	Long; David R. (Royston, GB2)
Assignee:	Glaxo Group Limited (London, GB2)
Application Number:	07/494,804
Patent Claims:	1. A pharmaceutical composition which is an aqueous formulation for oral administration of an effective amount of ranitidine and/or one or more physiologically acceptable salts thereof, said formulation comprising a stabilizing effective amount of ethanol and said composition having a pH in the range of 6.5-7.5. 2. A pharmaceutical composition according to claim 1 containing 2.5% to 10% weight/volume ethanol based on the complete formulation. 3. A pharmaceutical composition according to claim 1 containing 7% to 8% weight/volume ethanol based on the complete formulation. 4. A pharmaceutical composition according to claim 1 having a pH in the range 6.8 to 7.4. 5. A pharmaceutical composition according to claim 1 having a pH in the range 7.0 to 7.3. 6. A pharmaceutical composition according to claim 1 wherein said pH is obtained by the use of buffer salts. 7. A pharmaceutical composition according to claim 1 prepared using ranitidine in the form of the hydrochloride salt. 8. A pharmaceutical composition as claimed in claim 1, wherein the effective amount is 20-400 mg ranitidine per 10 ml dose expressed as free base. 9. A pharmaceutical composition as claimed in claim 1, wherein the effective amount is 20-200 mg ranitidine per 10 ml dose expressed as free base. 10. A pharmaceutical composition as claimed in claim 1, wherein the effective amount is 150 mg ranitidine per 10 ml dose expressed as free base. 11. A pharmaceutical composition which is an aqueous formulation of ranitidine suitable for oral administration containing 150 mg ranitidine per 10 ml dose expressed as free base, said formulation having a pH in the range 7.0 to 7.3 and also containing 7% to 8% weight/volume ethanol based on the complete formulation. 12. A pharmaceutical composition according to claim 11 wherein said pH is obtained by the use of buffer salts.

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