Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC)

Publication date: 15 October 2016 Source:International Journal of Pharmaceutics, Volume 512, Issue 1 Author(s): Pallavi Pawar, Yifan Wang, Golshid Keyvan, Gerardo Callegari, Alberto Cuitino, Fernando Muzzio A method for predicting dissolution profiles of directly compressed tablets for a fixed sustained release formulation manufactured in a continuous direct compaction (CDC) system is presented. The methodology enables real-time release testing (RTRt). Tablets were made at a target drug concentration of 9% Acetaminophen, containing 90% lactose and 1% Magnesium Stearate, and at a target compression force of 24kN. A model for predicting dissolution profiles was developed using a 34−1 fractional factorial experimental design built around this targeted condition. Four variables were included: API concentration (low, medium, high), blender speed (150rpm, 200rpm, 250rpm), feed frame speed (20rpm, 25rpm, 30rpm), 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 level” method, and a model-dependent approach based on Weibull’s model. Multivariate regression was built between the NIR scores as the predictor variables and the dissolution profile parameters as the response. The model successfully predicted the dissolution profiles of the individual tablets (similarity factor, f2 ∼72) manufactured a...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research