Root Cause Analysis For USP Dissolution and Tablet Disintegration Studies

USP dissolution testing is a standard method in pharmaceutical industry to characterize dissolution performance of solid dosage forms. Traditional analytical tools – including HPLC and UV spectroscopy – quantify the amount of drug dissolved but are blind to tablet disintegration mechanism that provides insight into the root cause of dissolution inconsistency. Focused Beam Reflectance Measurement (FBRM) is an in situ probe based technology which tracks the rate and degree of change to the particle size distribution.  FBRM measures inline and  can be directly installed in the dissolution vessel to track the tablet disintegration process. By monitoring the tablet and granule disintegration, drug release behavior from tablets and capsules can be determined.

Dr. Carrie Coutant of Eli Lilly has successfully applied inline particle size analysis to investigate changes in dissolution profile due to drug product from conversion upon exposure to high temperature and high humidity conditions. Dr. Coutant will be discussing the implementation of FBRM in dissolution testing to study the solid dosage dissolution behavior in the AAPS webinar – Novel Dissolution Methodologies: FBRM and Artificial Stomach Duodenum – on January 25, 2012.