In-depth experimental analysis of pharmaceutical twin-screw wet granulation in view of detailed process understanding

Publication date: 30 August 2017 Source:International Journal of Pharmaceutics, Volume 529, Issues 1–2 Author(s): Maxim Verstraeten, Daan Van Hauwermeiren, Kai Lee, Neil Turnbull, David Wilsdon, Mary am Ende, Pankaj Doshi, Chris Vervaet, Davinia Brouckaert, Séverine T.F.C. Mortier, Ingmar Nopens, Thomas De Beer Twin-screw wet granulation is gaining increasing interest within the pharmaceutical industry for the continuous manufacturing of solid oral dosage forms. However, limited prior fundamental physical understanding has been generated relating to the granule formation mechanisms and kinetics along the internal compartmental length of a twin-screw granulator barrel, and about how process settings, barrel screw configuration and formulation properties such as particle size, density and surface properties influence these mechanisms. One of the main reasons for this limited understanding is that experimental data is generally only collected at the exit of the twin-screw granulator barrel although the granule formation occurs spatially along the internal length of the barrel. The purpose of this study is to analyze the twin-screw wet granulation process using both hydrophilic and hydrophobic formulations, manufactured under different process settings such as liquid-to-solid ratio, mass throughput and screw speed, in such a way that the mechanisms occurring in the individual granulator barrel compartments (i.e., the wetting and different conveying and kneading c...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research