Ranitidine compositions

• US 5,593,685 A
• Filed: 04/11/1995
• Issued: 01/14/1997
• Est. Priority Date: 10/13/1992
• Status: Expired due to Fees

• Current Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Original Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Inventors: Bye, Alan, Huckle, Paul D., Lacey, Laurence F., Evans, Jill, Rue, Peter J.
• Primary Examiner(s): Spear, James M.
• Application Number:
  US08/411,664
• Time in Patent Office: 644 Days
• Field of Search: 424/465, 424/441, 424/439, 424/440, 424/464, 424/489, 514/974
• US Class Current: 424/439
• 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 31/341 not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention provides a chewable ranitidine tablet comprising ranitidine, or a physiologically acceptable salt thereof, a chewable base selected from sucrose, glucose, lactose, maltose, or a mixture thereof, a flavouring and, optionally, an intense sweetener and a process for its preparation.

Claims

1. A chewable ranitidine tablet consisting essentially of ranitidine, or a physiologically acceptable salt thereof, a chewable base selected from sucrose, glucose, lactose, maltose, or a mixture thereof, a flavouring and, optionally, saccharin or aspartame.

3. A tablet according to claim 1 wherein the chewable base is sucrose.

4. A tablet according to claim 1 containing saccharin or aspartame.

5. A tablet according to claim 1 containing a peppermint flavouring.

6. A tablet according to claim 1 wherein the ratio of ranitidine, or a physiologically acceptable salt thereof, to chewable base is in the range of 1:

85 to 1;

15 by weight.

7. A tablet according to claim 1 containing ranitidine hydrochloride.

8. A tablet according to claim 1 containing 10 to 800 mg ranitidine, expressed as the weight of free base, per tablet.

9. A tablet according to claim 8 containing 25 to 300 mg ranitidine, expressed as the weight of free base, per tablet.

10. A tablet according to claim 5 containing ranitidine hydrochloride.

11. A tablet according to claim 3 containing saccharin or aspartame.

12. A tablet according to claim 3 containing a peppermint flavoring.

13. A tablet according to claim 4 containing a peppermint flavoring.

14. A tablet according to claim 3 wherein the ratio of ranitidine, or a physiologically acceptable salt thereof, to chewable base is in the range of 1:

85 to 1;

15 by weight.

15. A tablet according to claim 4 wherein the ratio of ranitidine, or a physiologically acceptable salt thereof, to chewable base is in the range of 1:

85 to 1;

15 by weight.

16. A tablet according to claim 5 wherein the ratio of ranitidine, or a physiologically acceptable salt thereof, to chewable base is in the range of 1:

85 to 1;

15 by weight.

17. A tablet according to claim 3 containing ranitidine hydrochloride.

18. A tablet according to claim 4 containing ranitidine hydrochloride.

2. A composition consisting essentially of ranitidine, or a physiologically acceptable salt thereof, a chewable base selected from sucrose, glucose, lactose, maltose, or a mixture thereof, a flavouring and, optionally, saccharin or aspartame.