Pharmaceutical composition comprising a solid dispersion with a polymer matrix containing a continuous polydextrose phase and a continuous phase of a polymer other than polydextrose

摘要

The present invention relates to a solid pharmaceutical composition comprising a solid dispersion containing at least one active principle and a pharmaceutically acceptable polymer matrix,
a characterized in that said pharmaceutically acceptable polymer matrix comprises a blend of (i) polydextrose, in the form of a continuous polydextrose phase, in order to promote the disintegration of the composition in an aqueous medium, and (ii) at least one polymer other than polydextrose, in the form of a continuous phase of this polymer, whereby the polydextrose is in a concentration of at least 20 wt % and the at least one polymer other than polydextrose is in a concentration of at least 20 wt % in relation to the total weight of said pharmaceutically acceptable polymer matrix.

主权项

1. A solid pharmaceutical composition comprising a solid dispersion containing N piperidino-5-(4-bromphenyl)-1-(2,4-dichlorophenyl)-4-methylpyrazole-3-carboxamide and a pharmaceutically acceptable polymer matrix, wherein said pharmaceutically acceptable polymer matrix comprises a blend of (i) 80% by weight polydextrose, in the form of a continuous phase, and (ii) 20% by weight copovidone, in the form of a continuous phase wherein said composition disintegrates in demineralized water at 37° C. in about 15 minutes.