Process for preparing solid pharmaceutical dosage forms

Details Process for preparing solid pharmaceutical dosage forms Process for preparing solid pharmaceutical dosage forms

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 9/00 (2006.01) A61K 45/08 (2006.01)

Patent

CA 2278785

This invention relates to a process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste which process comprises: (i) forming a solution or a suspension in a solvent of a water soluble or water dispersible carrier, a filler and the pharmaceutically active substance with the unacceptable taste in association with a lipid, the weight ratio of the pharmaceutically active substance to the lipid being in the range of from 1:1 to 1:10 and the weight ratio of the carrier to the lipid being in the range of from 5:1 to 1:15; (ii) forming discrete units of the suspension or solution; and (iii) removing the solvent from the discrete units under conditions whereby unit dosages are formed comprising a network of carrier/filler carrying a dosage of the pharmaceutically active substance in association with the lipid; oral solid rapidly disintegrating dosage forms prepared by such a process are also provided.

L'invention concerne un procédé de préparation d'une forme galénique, orale, solide et à désintégration rapide d'une substance active sur le plan pharmaceutique et ayant un goût très désagréable. Ledit procédé comprend les étapes consistant (i) à former, dans un solvant, une solution ou une suspension d'un excipient soluble ou dispersible dans l'eau, d'une charge et de ladite substance active sur le plan pharmaceutique, ayant un goût très désagréable et associée à un lipide, le rapport pondéral de ladite substance et du lipide étant compris entre 1:1 et 1:10, le rapport pondéral de l'excipient et du lipide étant compris entre 5:1 et 1:15; (ii) à former des unités individuelles de la suspension ou de la solution; et (iii) à extraire le solvant de ces unités dans des conditions permettant la formation de doses unitaires qui comprennent un réseau de l'excipient/charge contenant une dose de la substance active sur le plan pharmaceutique associée au lipide. L'invention concerne également des formes galéniques, orales, solides, et à désintégration rapide préparées grâce à un tel procédé.

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