Process for the preparation of an oral solid dosage form containing diclofenac
AssigneeCiba-Geigy Corporation
InventorsPeter Heinrich Stahl, Claudio Gamboni
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Abstract
The invention relates to a novel advantageous process for the preparation of an oral solid dosage form containing diclofenac or a pharmaceutically acceptable salt thereof. The dosage form is obtainable by direct compression of an inclusion compound consisting of diclofenac, or a salt thereof, with .gamma.-cyclodextrin. The inclusion compound itself is novel and is likewise an object of the invention.
Claims5
A process for the preparation of compressed tablets containing diclofenac or a pharmaceutically acceptable salt thereof, which comprises preparing an inclusion compound consisting of .gamma.-cyclodextrin and a therapeutic agent selected from the group consisting of diclofenac and a pharmaceutically acceptable salt thereof, and compressing said inclusion compound directly into compressed tablets, with the addition of pharmaceutically-acceptable excipients.
A process for the preparation of an inclusion compound comprising .gamma.-cyclodextrin and a therapeutic agent selected from the group consisting of diclofenac and a pharmaceutically acceptable salt thereof, which comprises reacting the therapeutic agent with .gamma.-cyclodextrin in the presence of water, wherein the step of reacting the therapeutic agent with .gamma.-cyclodextrin in the presence of water is accomplished by preparing an aqueous suspension of the therapeutic agent and .gamma.-cyclodextrin, converting said suspension into a solution by adjusting the pH to the alkaline range, neutralizing this solution with an acid or a buffer solution, and precipitating or crystallizing the resultant inclusion compound, and purifying or isolating the resultant inclusion compound.
Dependencies are inferred from the claim text.