Assessment of dynamic image analysis as a surrogate dissolution test for a coated multiparticulate product.
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 mum. 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.
Heinicke
Grant
G
Formulation Development, Actavis, Elizabeth, NJ 07207, USA. gheinicke@actavis.com
Schwartz
Joseph B
JB
D020099:Coated Materials, Biocompatible / Q000032:analysis*; D007091:Image Processing, Computer-Assisted / Q000379:methods*; D010316:Particle Size; D010599:Pharmacokinetics
D020099:Coated Materials, Biocompatible