Effect of impeller design on homogeneity, size and strength of pharmaceutical granules produced by high-shear wet granulation--颗粒学报PARTICUOLOGY

Mirza, Z., Liu, J., Glocheux, Y., Albadarin, A. B., Walker, G. M., & Mangwandi, C. (2015). Effect of impeller design on homogeneity, size and strength of pharmaceutical granules produced by high-shear wet granulation. Particuology, 23, 31-39. https://doi.org/10.1016/j.partic.2014.12.009

Effect of impeller design on homogeneity, size and strength of pharmaceutical granules produced by high-shear wet granulation

Zakaria Mirza ^a, Jiangtao Liu ^a, Yoann Glocheux ^a, Ahmad B. Albadarin ^{a b}, Gavin M. Walker ^{a b}, Chirangano Mangwandi ^a *

a School of Chemistry and Chemical Engineering, Queen's University Belfast, Belfast BT9 5AG, Northern Ireland, UK
b Synthesis & Solid State Pharmaceuticals Center (SSPC), Department of Chemical and Environmental Science, University of Limerick, Ireland

10.1016/j.partic.2014.12.009

Volume 23, December 2015, Pages 31-39

Received 1 September 2014, Revised 25 November 2014, Accepted 3 December 2014, Available online 20 April 2015, Version of Record 2 December 2015.

E-mail: c.mangwandi@qub.ac.uk

Highlights

• Methylene blue was used as an inert tracer in lactose granulation experiments.

• Impeller design had a significant impact on high shear granulation.

• High temperature flexible beater was the best in terms of yield and homogeneity.

• Highest granule strength was achieved using a stainless steel power whisk.

Abstract

Small mixer impeller design is not tailored for granulation because impellers are intended for a wide range of processes. The aim of this research was to evaluate the performances of several impellers to provide guidance on the selection and design for the purposes of granulation. Lactose granules were produced using wet granulation with water as a binder. A Kenwood KM070 mixer was used as a standard apparatus and five impeller designs with different shapes and surface areas were used. The efficacy of granulate formation was measured by adding an optically sensitive tracer to determine variations in active ingredient content across random samples of granules from the same size classes. It was found that impeller design influenced the homogeneity of the granules and therefore can affect final product performance. The variation in active ingredient content across granules of differing size was also investigated. The results show that small granules were more potent than larger granules.

Graphical abstract

Keywords

Granule strength; Impeller design; Homogeneity; High-shear granulation; Lactose monohydrate

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