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Claims for Patent: 4,585,790

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Claims for Patent: 4,585,790

Title: Pharmaceutical compositions
Abstract:Aqueous formulations of raniditine have been found to have enhanced shelf life provided that they are formulated with a pH in the range 6.5--7.5. Suitable aqueous formulations include injections for intravenous and intramuscular administration, continuous infusions and oral preparations such as syrups.
Inventor(s): Padfield; John M. (Meldreth, GB2), Winterborn; Ian K. (Stevenage, GB2)
Assignee: Glaxo Group Limited (London, GB2)
Application Number:06/609,215
Patent Claims: 1. A pharmaceutical composition which is an aqueous formulation containing an effective amount of ranitidine and/or one or more physiologically acceptable salts thereof for treatment of conditions mediated through histamine H.sub.2 -receptors, said formulation having a pH within the range of 6.5-7.5.

2. A pharmaceutical composition according to claim 1 having a pH in the range 6.7 to 7.3.

3. A pharmaceutical composition according to claim 1 having a pH in the range 6.8 to 7.1.

4. A pharmaceutical composition according to claim 1 in which said pH is adjusted by means of suitable buffer salts.

5. A pharmaceutical composition according to claim 4 in which said buffer salts are potassium dihydrogen orthophosphate and disodium hydrogen orthophosphate or citric acid and disodium hydrogen orthophosphate.

6. A pharmaceutical composition according to claim 1 in a form suitable for parenteral administration.

7. A pharmaceutical composition according to claim 6 in a form suitable for injection and containing 10 to 100 mg/ml ranitidine, expressed as free base.

8. A pharmaceutical composition according to claim 6 in a form suitable for continuous infusion and containing 0.1-2.0 mg/ml raniditine, expressed as free base.

9. A pharmaceutical composition according to claim 1 in a form suitable for oral administration.

10. A pharmaceutical composition according to claim 9 containing 20-400 mg per 10 ml dose.

11. A pharmaceutical composition according to claim 1 containing ranitidine in the form of its hydrochloride salt.

12. A process for the production of a composition of claim 1 suitable for parenteral administration, which comprises dissolving ranitidine and/or one or more physiologically acceptable salts thereof and said remaining constituents in water suitable for injection, followed by sterilisation.

13. A process for the production of a composition of claim 1 suitable for oral administration which comprises adding an aqueous solution of ranitidine and/or one or more physiologically acceptable salts thereof to an aqueous solution or dispersion of a viscosity enhancing agent.
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