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Claims for Patent: 5,102,665

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Claims for Patent: 5,102,665

Title: Pharmaceutical compositions
Abstract:An effervescent pharmaceutical composition for oral use comprising ranitidine or a physiologically acceptable salt thereof, a monoalkali metal citrate, and an alkaline carbonate or bicarbonate.
Inventor(s): Schaeffer; Alain E. E. (Saint Sebastien de Morsent, FR)
Assignee: Glaxo Group Limited (London, GB2)
Application Number:07/666,102
Patent Claims: 1. An effervescent pharmaceutical composition for oral use in the treatment of a condition mediated through histamine H.sub.2 -receptors, the composition combining the required degree of stability with a rapid rate of dissolution, the composition comprising an effective amount of ranitidine or a physiologically acceptable salt thereof to relieve said condition, and effective amounts of an alkali metal citrate and an alkaline carbonate or bicarbonate to produce the effervescence, characterised in that the alkali metal citrate is solely a monoalkali metal citrate.

2. A pharmaceutical composition as claimed in claim 1 containing ranitidine hydrochloride.

3. A pharmaceutical composition as claimed in claim 1 wherein the monoalkali metal citrate is monosodium citrate.

4. A pharmaceutical composition as claimed in claim 1 wherein the alkaline carbonate or bicarbonate is an alkali metal or alkaline earth metal carbonate or bicarbonate.

5. A pharmaceutical composition as claimed in claim 4 wherein the alkaline carbonate or bicarbonate is sodium bicarbonate.

6. A pharmaceutical composition as claimed in claim 1 in unit dose form containing 50 to 600 mg. ranitidine per unit dose expressed as the weight of free base.

7. A pharmaceutical composition as claimed in claim 1 in unit dose form containing 50 to 500 mg. ranitidine per unit dose expressed as the weight of free base.

8. A pharmaceutical composition as claimed in claim 6 containing 150 to 300 mg. ranitidine per unit dose.

9. A pharmaceutical composition as claimed in claim 1 containing 25% to 55% (w/w) monoalkali metal citrate.

10. A pharmaceutical composition as claimed in claim 1 containing 25% to 55% (w/w) alkaline carbonate or bicarbonate.

11. An effervescent pharmaceutical composition for oral use in the treatment of a condition mediated through histamine H.sub.2 -receptors, the composition combining the required degree of stability with a rapid rate of dissolution, the composition comprising an effective amount of ranitidine hydrochloride to relieve said condition, and effective amounts of monosodium citrate and sodium bicarbonate to produce the effervescence, wherein the monosodium citrate is the only citrate present.

12. A pharmaceutical composition as claimed in claim 11 comprising ranitidine hydrochloride (2% to 30% w/w), monosodium citrate (35% to 45% w/w) and sodium bicarbonate (35% to 45% w/w).

13. A pharmaceutical composition as claimed in claim 12 in unit dose form containing 150 to 300 mg. ranitidine per unit dose, expressed as the weight of free base.

14. A pharmaceutical composition as claimed in claim 1 containing at least one physiologically acceptable carrier or excipient.

15. A pharmaceutical composition as claimed in claim 1 in the form of tablets, granules or a powder.

16. A pharmaceutical composition as claimed in claim 15 in the form of tablets.

17. A pharmaceutical composition as claimed in claim 16 containing a binding agent (1% to 2% w/w) and a lubricant (2% to 4% w/w).

18. A pharmaceutical composition as claimed in claim 15 in the form of sachets containing a fixed dose of powder or granules.

19. A pharmaceutical composition as claimed in claim 18 containing a binding agent (2% to 4% w/w).

20. A pharmaceutical composition as claimed in claim 1 additionally containing one or more flavouring and/or sweetening agents.

21. A pharmaceutical composition as claimed in claim 11 comprising ranitidine hydrochloride (2% to 30% w/w), monosodium citrate (35% to 45% w/w) and sodium bicarbonate (35% to 45% w/w), and additionally containing sodium saccharin as a sweetening agent, in which the ranitidine content is 150 mg per unit dose (expressed as the weight of free base).

22. A pharmaceutical composition as claimed in claim 11 comprising ranitidine hydrochloride (2% to 30% w/w), monosodium citrate (35% to 45% w/w) and sodium bicarbonate (35% to 45% w/w), and additionally containing sodium cyclamate as a sweetening agent, in which the ranitidine content is 150 mg per unit dose (expressed as the weight of free base).

23. A pharmaceutical composition as claimed in claim 11 comprising ranitidine hydrochloride (2% to 30% w/w), monosodium citrate (35% to 45% w/w) and sodium bicarbonate (35% to 45% w/w), and additionally containing aspartame as a sweetening agent, in which the ranitidine content is 150 mg per unit dose (expressed as the weight of free base).

24. A pharmaceutical composition as claimed in claim 11 comprising ranitidine hydrochloride (2% to 30% w/w), monosodium citrate (35% to 45% w/w) and sodium bicarbonate (35% to 45% w/w), and additionally containing sodium saccharin as a sweetening agent, in which the ranitidine content is 300 mg per unit dose (expressed as the weight of free base).

25. A pharmaceutical composition as claimed in claim 11 comprising ranitidine hydrochloride (2% to 30% w/w), monosodium citrate (35% to 45% w/w) and sodium bicarbonate (35% to 45% w/w), and additionally containing sodium cyclamate as a sweetening agent, in which the ranitidine content is 300 mg per unit dose (expressed as the weight of free base).

26. A pharmaceutical composition as claimed in claim 11 comprising ranitidine hydrochloride (2% to 30% w/w), monosodium citrate (35% to 45% w/w) and sodium bicarbonate (35% to 45% w/w), and additionally containing aspartame as a sweetening agent, in which the ranitidine content is 300 mg per unit dose (expressed as the weight of free base).

27. A pharmaceutical composition as claimed in claim 7 containing 150 to 300 mg. ranitidine per unit dose.

28. A pharmaceutical composition as claimed in claim 11 containing at least one physiologically acceptable carrier or excipient, said composition being in the form of tablets, granules or a powder.

29. A pharmaceutical composition as claimed in claim 28 in the form of tablets.

30. A pharmaceutical composition as claimed in claim 29 containing a binding agent (1% to 2% w/w) and a lubricant (2% to 4% w/w).

31. A pharmaceutical composition as claimed in claim 28 in the form of sachets containing a fixed dose of powder or granules.

32. A pharmaceutical composition as claimed in claim 31 containing a binding agent (2% to 4% w/w).

33. A pharmaceutical composition as claimed in claim 11 additionally containing one or more flavouring and/or sweetening agents.
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