Pharmaceutical compositions

• US 4,585,790 A
• Filed: 05/11/1984
• Issued: 04/29/1986
• Est. Priority Date: 05/13/1983
• Status: Expired due to Term

• Current Assignee: Glaxo Group Limited Clarges House
• Original Assignee: Glaxo Group Limited (GSK plc)
• Inventors: Padfield, John M., Winterborn, Ian K.
• Primary Examiner(s): FRIEDMAN, STANLEY
• Application Number:
  US06/609,215
• Time in Patent Office: 718 Days
• Field of Search: 424/285, 514/471
• US Class Current: 514/471
• CPC Class Codes: A61K 31/34 having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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.

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 H₂ -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.