July 30, 2012
Examination of drug particle size distributions (PSD), the extent of drug particle aggregates and content/blending uniformity is an important part in characterization of pharmaceutical products as it directly correlates with the dissolution rate of the Active Pharmaceutical Ingredient (API). Such characterization is also necessary for measuring product quality as well as establishing bioequivalence (BE), evaluating out of specification issues and addressing pharmaceutical anti-counterfeiting. This task is particularly critical for controlled release products with multiple actives and excipients since traditional analytical methods are not suitable for in-depth characterization of these complex formulations. Drug-specific PSD reporting is a challenging task for multiple ingredient formulations, including controlled-release capsules, beads, bi-layered tablets, stents and other advanced delivery systems.