Facts, fallacies and future of dissolution testing of polysaccharide based colon-specific drug delivery.

Colonic diseases like ulcerative colitis, Crohn's disease, and colon cancer are on rise due to variations in the dietary and lifestyle habits. Increase in prevalence of such diseases has augmented the interest of researchers in colon targeted drug delivery systems. Polysaccharide coating has emerged as one of the most successful approaches in this direction. Evaluation of such systems, however, demands an efficient dissolution method in terms of convenience, economy, relevance and reproducibility. It is problematic to mimic the dynamic and ecologically diverse features of the colon. A number of dissolution approaches were tried which include incorporation of polysaccharide-degrading enzymes, rat caecal contents, human faecal slurries, and multi-stage culture systems. Till date, pursuit for cost-effective and animal-sparing colon-specific bio-relevant dissolution media has been a foremost challenge facing pharmaceutical scientists over many decades. This article reviews various dissolution methods adopted to mimic the in vivo performance of dosage forms that are used for colon targeting. It also highlights limitations of the available methods and conditions that should be taken into account while designing a bio-relevant dissolution method for such systems.