Formulation Design and Experiment Interpretation through Torque Measurements in High-Shear Wet Granulation

A PAT approach to improve process understanding of high shear wet granulation through in-line particle measurement using FBRM C35.

This article summarizes the investigation of in-line particle characterization during high shear wet granulation (HSWG) using focused beam reflectance measurement (FBRM) for enhanced process understanding, which is part of an effort to develop this drug product within the framework of quality by design (QbD) and process analytical technology (PAT). Traditionally, the effectiveness of in-line mo...

Formulation and Evaluation of Extended- Release Tablet of Zolpidem Tartrate by Wet Granulation Technique

The goal of this study was to design and evaluate extended - release system of the hypnotic agent, Zolpidemtartrate usefulness for the treatment of insomnia. The half-life of this drug is about 1.9 - 3 hours that indicatingit a candidate for the extended release formulation. Our investigation relates to development of extendeddrug delivery system based on Hydroxy propyl methyl cellulose (HPMCK4...

Scale-up studies on high shear wet granulation process from mini-scale to commercial scale.

A newly developed mini-scale high shear granulator was used for scale-up study of wet granulation process from 0.2 to 200 L scales. Under various operation conditions and granulation bowl sizes, powder mixture composed of anhydrous caffeine, D-mannitol, dibasic calcium phosphate, pregelatinized starch and corn starch was granulated by adding water. The granules were tabletted, and disintegratio...

Effect of operating conditions and physico–chemical properties on the wet granulation kinetics in high shear mixer

Aspects of Screw Design for Wet Granulation Extrusion

This paper discusses our preliminary trials examining the particle size and particle shape of granules produced by different screw elements in a co-rotating twin-screw extruder. In general, conveying elements did not provide the necessary consolidation to allow large particles to grow in significant quantity, whereas the different mixing elements led to the large particles desired for tablettin...