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Claims for Patent: 5,955,488

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Claims for Patent: 5,955,488

Title: Freeze-dried compositions
Abstract:The invention relates to a freeze-dried dosage form for oral administration capable of being rapidly disintegrated in the mouth comprising ondansetron in the form of its free base or a pharmaceutically acceptable solvate thereof and one or more pharmaceutically acceptable excipients. Methods for the manufacture of such compositions and for their use in the treatment of conditions mediated through the action of 5-hydroxytryptamine (5HT) at 5HT.sub.3 receptors are also described.
Inventor(s): Winterborn; Ian Keith (Ware, GB)
Assignee: Glaxo Wellcome Inc. (Mississauga, CA)
Application Number:09/066,762
Patent Claims: 1. A method of treating a condition mediated through the action of 5HT at 5HT.sub.3 receptors in man, which comprises swallowing a rapidly disintegrated orally administered freeze-dried dosage form of a composition comprising ondansetron in the form of its free base or a pharmaceutically acceptable solvate thereof and one or more pharmaceutically acceptable excipients.

2. The method of claim 1, wherein the ondansetron is in the form of its free base.

3. The method of claim 1, wherein ondansetron, expressed as free base, comprises 0.1 to 10% w/w of the composition.

4. The method of claim 2, wherein the amount of ondansetron in the composition, comprises 0.1 to 10% w/w of the composition.

5. The method of claim 1, wherein the amount of ondansetron in the composition, expressed as free base, is in the range of 0.1 to 100 mg.

6. The method of claim 2, wherein the amount of ondansetron in the composition, expressed as free base, is in the range of 0.1 to 100 mg.

7. The method of claim 3, wherein the amount of ondansetron in the composition, expressed as free base, is in the range of 0.1 to 100 mg.

8. The method of claim 1, wherein the composition comprises ondansetron in the form of its free base, gelatin, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, strawberry flavoring aid, aspartame, and mannitol.

9. The method of claim 3, wherein the composition comprises ondansetron in the form of its free base, gelatin, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, strawberry flavoring aid, aspartame, and mannitol.

10. The method of claim 4, wherein the composition comprises ondansetron in the form of its free base, gelatin, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, strawberry flavoring aid, aspartame, and mannitol.

11. The method of claim 5, wherein the composition comprises ondansetron in the form of its free base, gelatin, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, strawberry flavoring aid, aspartame, and mannitol.

12. The method of claim 6, wherein the composition comprises ondansetron in the form of its free base, gelatin, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, strawberry flavoring aid, aspartame, and mannitol.

13. The method of claim 3 for the treatment of emesis.

14. The method of claim 2 for the treatment of emesis.

15. The method of claim 4 for the treatment of emesis.

16. The method of claim 5 for the treatment of emesis.

17. The method of claim 6 for the treatment of emesis.

18. The method of claim 8 for the treatment of emesis.

19. The method of claim 9 for the treatment of emesis.

20. A method of treating a condition mediated through the action of 5HT at 5HT.sub.3 receptors in a mammal which comprises swallowing a rapidly disintegrated orally administered freeze-dried dosage form of a composition comprising ondansetron in the form of its free base or a pharmaceutically acceptable solvate thereof and one or more pharmaceutically acceptable excipients.
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