Pharmaceutical compositions based on Diclofenae

DETAILED DESCRIPTION 1.
A method for obtaining an average Tmax of diclofenac in a human patient between 5 and 30 minutes after administering said diclofenac to said patient, said average Tmax having a coefficient of variation (CV%) less than about 70%, comprising orally administering a diclofenac formulation to said patient, wherein said diclofenac formulation comprises diclofenac in acid and/or salt form together with an alkali metal bicarbonate selected from the group consisting of sodium bicarbonate, potassium bicarbonate and mixtures thereof, wherein said alkali metal bicarbonate is present in an amount of from about 20 to about 80% by weight based on the weight of said diclofenac, wherein said diclofenac formulation further contains a flavoring substance selected from the group consisting of mint, aniseed, ammonium glycyrrhizinate and mixtures thereof whereby palatability and astringency effects are eliminated, and wherein said diclofenac formulation is selected from: a.
a powder formulation dissolved or dispersed in water; and b.
a fast release layer present in a two layered diclofenac tablet that comprises a slow release layer and a fast release layer.
2.
The method according to of claim 1 where said average Tmax is reached 13-27 minutes after said administration.
3.
A The method according to of claim 1 wherein said alkali metal bicarbonate is present in an amount of from about 40 to about 80% by weight based on the weight of said diclofenac.
4.
The method of claim 1 wherein said diclofenac formulation comprises from about 10 to about 60 mg.
of diclofenac in its potassium salt form.
5.
The method of claim 1 wherein said diclofenac formulation comprises from about 10 to about 60 mg.
of diclofenac in its sodium salt form.
6.
The method of claim 1 wherein said alkali metal bicarbonate is sodium bicarbonate.
7.
The method of claim 1 wherein said alkali metal bicarbonate is potassium bicarbonate.
8.
The method of claim 1 wherein said diclofenac formulation is said powder formulation.
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