C-SOPS Webinar Series Presents

 

Enabling real time release testing by NIR
prediction of dissolution of tablets by
Continuous Direct Compression (CDC)

Pallavi Pawar, Ph.D. 
Wednesday July 27th 2016 @ 1PM EST

 

The methodology enables real-time release testing. Tablets were made at a target drug concentration of 9% APAP, containing 90% lactose and 1% Magnesium Stearate, and at a target compression force of 24 kN. A model for predicting dissolution profiles was developed using a fractional factorial experimental design built around this targeted condition. This experimental design consisted of a 3^(4-1) fractional design resulting into a total of 27 testing conditions with additional repeated center points. Four variables were included: API concentration (low, medium, high), Blender speed (150rpm, 200rpm, 250rpm), feed frame speed (20rpm, 25rpm, 30rpm) and compaction force (8KN, 16KN, 24KN). The tablets thus obtained were scanned at-line in transmission mode using Near IR spectroscopy. The dissolution profiles were described using two approaches, a model-independent “shape and levelâ€