Assessment of Dynamic Image Analysis as a Surrogate Dissolution Test for a Coated Multiparticulate Product

Abstract

Dynamic image analysis (DIA) was used to measure particle diameter (D50) of in—process samples removed during fluid bed coating. A single, rapid measurement gave D50 to within 4 μm. Samples removed at intervals of 2% weight gain were readily distinguishable by DIA and by their drug release profiles. Drug release was related to D50. DIA was assessed as a surrogate dissolution test with considerable potential. Current limitations of the approach were presented.

Keywords:

• dynamic image analysis
• drug release
• Wurster coating
• multi-particulate
• pellet