Influence of Formulation Factors, Process Parameters, and Selected Quality Attributes on Carvedilol Release from Roller-Compacted Hypromellose-Based Matrix Tablets.

The importance of roller compaction is recently increasing. This study evaluates the combined effects of formulation factors, process parameters, and selected quality attributes on drug release from roller-compacted hypromellose-based matrix tablets containing carvedilol as a model drug. The influence of selected factors was statistically assessed and good predictive models were developed for various time points of the release profile.

Implementation of spatial filtering technique in monitoring roller compaction process.

This study investigates the use of the spatial filtering technique (SFT) to monitor the particle size distribution (PSD) of granules obtained by roller compaction. In the first part of the study, the influence of the selected process and formulation parameters on the PSD of granules is monitored at-line using SFT. The correlation between the PSD obtained by SFT, sieve analysis, laser diffraction, and dynamic image analysis was satisfactory.

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing.

This article presents an overview of using process analytical technology in monitoring the roller compaction process. In the past two decades, near-infrared spectroscopy, near-infrared spectroscopy coupled with chemical imaging, microwave resonance technology, thermal effusivity and various particle imaging techniques have been used for developing at-, off-, on- and in-line models for predicting critical quality attributes of ribbons and subsequent granules and tablets. The common goal of all these methods is improved process understanding and process control, and thus improved production of high-quality products.