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

Eur J Pharm Biopharm. 2009 Sep;73(1):154-61. doi: 10.1016/j.ejpb.2009.05.006. Epub 2009 May 22.

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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chemistry, Pharmaceutical / methods*
  • Fenofibrate / chemistry*
  • Fenofibrate / metabolism*
  • Inulin / chemistry
  • Inulin / metabolism
  • Solubility
  • Tablets
  • X-Ray Diffraction / methods

Substances

  • Tablets
  • Inulin
  • Fenofibrate