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Strongly enhanced dissolution rate of fenofibrate solid dispersion tablets by incorporation of superdisintegrants.

Research paper by P P Srinarong, J H JH Faber, M R MR Visser, W L J WL Hinrichs, H W HW Frijlink

Indexed on: 26 May '09Published on: 26 May '09Published in: European Journal of Pharmaceutics and Biopharmaceutics



Abstract

In this study, it was shown that the incorporation of superdisintegrants in solid dispersion tablets containing a high drug load can strongly enhance the dissolution rate of the highly lipophilic drug fenofibrate. In addition, the dissolution rate was more increased when the superdisintegrant was incorporated in the drug containing solid dispersions than when it was physically mixed with the solid dispersions. The dissolution rate enhancement strongly depended on the type of superdisintegrants and increased in the order Polyplasdone XL-10<Polyplasdone XL<Ac-Di-Sol approximately Primojel. The dissolution behavior also depended on the type of hydrophilic carriers. Solid dispersion tablets based on inulin 4 kDa, polyethylene glycol 20K and polyvinylpyrrolidone K30 showed a much faster dissolution than those based on mannitol and hydroxypropyl-beta-cyclodextrin. Finally, inulin 4 kDa-based solid dispersion tablets showed excellent storage stability, while polyethylene glycol 20K-and polyvinylpyrrolidone K30-based solid dispersion tablets did not.