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Claims for Patent: 7,482,377

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Claims for Patent: 7,482,377

Title:Pharmaceutical compositions and methods of treatment based on diclofenac
Abstract:New pharmaceutical compositions for oral use containing diclofenac together with alkali metal bicarbonates in amounts of from 20 to 80 by weight with respect to diclofenac are described. These compositions are entirely palatable and free from any unpleasant taste or other, side effects; in particular, these formulations permit to obtain in human patients higher C.sub.max of the active principle and shorter T.sub.max together with a lower coefficient of variation.
Inventor(s): Reiner; Alberto (Como, IT), Reiner; Giorgio (Como, IT)
Assignee: Kowa Pharmaceuticals America, Inc. (Montgomery, AL)
Application Number:11/132,024
Patent Claims: 1. A method of treating pain comprising administering to a host in need thereof a pharmaceutical formulation for oral administration containing diclofenac in its acid and/or salt form together with one or more alkali metal bicarbonates and customary excipients and adjuvants, wherein said alkali metal bicarbonates are present in an amount of from 20 to 80% by weight based on the weight of the acid form of diclofenac, and further wherein said formulation when administered is an intact tablet, or a powder formulation dissolved or dispersed in water, and wherein said formulation contains not more than 50 mg of diclofenac potassium or the equivalent amount of diclofenac or an alternative pharmaceutically acceptable diclofenac salt.

2. The method of claim 1 wherein said diclofenac is present in its potassium and/or sodium salt form.

3. The method of claim 2 wherein said formulation is administered as an intact tablet.

4. The method of claim 2 wherein said formulation is administered as a powder formulation dissolved or dispersed in water.

5. The method of claim 2 wherein said alkali metal bicarbonates are potassium and/or sodium bicarbonates.

6. The method of claim 1 wherein said formulation is administered as an intact tablet.

7. The method of claim 1 wherein said formulation is administered as a powder formulation dissolved or dispersed in water.

8. The method of claim 1 further comprising, before administering said formulation, providing a unit dose powder of diclofenac in acid and/or salt form and dissolving or dispersing said diclofenac in water to provide said formulation.

9. The method of claim 1 wherein said formulation is a liquid.

10. The method of claim 1 wherein said formulation comprises diclofenac potassium and potassium bicarbonate.

11. A method of treating pain comprising administering to a host in need thereof a pharmaceutical formulation for oral administration containing diclofenac as 50 mg. of diclofenac potassium together with one or more alkali metal bicarbonates or carbonates or mixtures thereof and customary excipients and adjuvants, wherein said alkali metal bicarbonates or carbonates or mixtures thereof are present in an amount of from 20 to 80% by weight based on the weight of the acid form of diclofenac, and further wherein said formulation when administered is an intact tablet or a powder formulation dissolved or dispersed in water.

12. The method of claim 11 wherein said formulation is a tablet comprising 50 mg. of diclofenac potassium.

13. The method of claim 11 further comprising, before administering said formulation, providing a unit dose powder of diclofenac potassium and dissolving or dispersing said diclofenac potassium in water to provide said formulation.

14. The method of claim 11 wherein said formulation is a liquid.

15. A method of treating pain according to claim 1, comprising orally administering to a host in need thereof a pharmaceutical formulation for oral administration containing diclofenac in sodium or potassium salt form together with sodium or potassium bicarbonates or mixtures thereof and customary excipients and adjuvants, wherein said sodium or potassium bicarbonates are present in an amount of from 20 to 80% by weight based on the weight of the acid form of diclofenac.
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