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Claims for Patent: 5,854,270

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Claims for Patent: 5,854,270

Title: Oral compositions containing ondansetron
Abstract:The invention relates to a liquid composition for oral administration comprising ondansetron or a pharmaceutically acceptable derivative thereof, a sweetener and one or more pharmaceutically acceptable excipients. The sweetener comprises one or more polyhydric alcohols and the pH of the combination lies in the range 2.0 to 5.0. Methods for the manufacture of such compositions and for their use in the treatment of conditions mediated through the action of 5-hydroxytryptamine (5 HT) at 5 HT.sub.3 receptors are also included.
Inventor(s): Gambhir; Renu (Mississauga, CA)
Assignee: Glaxo Wellcome Inc. (Mississauga, CA)
Application Number:08/817,831
Patent Claims: 1. A liquid composition for oral administration comprising ondansetron or a pharmaceutically acceptable derivative thereof, a sweetener and one or more pharmaceutically acceptable excipients, characterised in that the sweetener comprises sorbitol and the pH of the composition lies in the range 2.0 to 5.0.

2. A composition according to claim 1 comprising ondansetron in the form of its hydrochloride.

3. A composition according to claim 1 comprising ondansetron in the form of its hydrochloride dihydrate.

4. A composition according to claim 1 wherein ondansetron is in the form of its hydrochloride dihydrate and the sweetener is sorbitol.

5. A composition according claim 1 wherein the concentration of ondansetron in the composition, expressed as free base, lies in the range of 0.005 to 1% w/v.

6. A composition according to claim 1 wherein the total sorbitol content of the composition, expressed in terms of sorbitol solids, lies in the range of 20 to 85% w/v.

7. A composition according to claim 1 wherein the pH lies within the range 2.5 to 4.5.

8. A composition according to claim 1 wherein the concentration of ondansetron in the composition, expressed as free base, lies in the range of 0.02 to 0.2% w/v; the total sorbitol content of the composition, expressed in terms of sorbitol solids, lies in the range of 30 to 50% w/v; and the pH lies within the range 3.0 to 4.0.

9. A composition according to claim 1 having a viscosity which lies in the range 1 to 100 cps.

10. A composition according to claim 1 which is substantially free of fructose or a fructose containing sacharide.

11. A method of treating a mammal, including man, suffering from a condition mediated through the action of 5 HT at 5 HT.sub.3 receptors, which comprises administration of a composition according to claim 1.

12. A method according to claim 11 for the treatment of emesis.
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