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Granulation of increasingly hydrophobic formulations using a twin screw granulator.
Int J Pharm. 2014 Nov 20; 475(1-2):82-96.IJ

Abstract

The application of twin screw granulation in the pharmaceutical industry has generated increasing interest due to its suitability for continuous processing. However, an understanding of the impact of formulation properties such as hydrophobicity on intermediate and finished product quality has not yet been established. Hence, the current work investigated the granulation behaviour of three formulations containing increasing amounts of hydrophobic components using a Consigma™-1 twin screw granulator. Process conditions including powder feed rate, liquid to solid ratio, granulation liquid composition and screw configuration were also evaluated. The size of the wet granules was measured in order to enable exploration of granulation behaviour in isolation without confounding effects from downstream processes such as drying. The experimental observations indicated that the granulation process was not sensitive to the powder feed rate. The hydrophobicity led to heterogeneous liquid distribution and hence a relatively large proportion of un-wetted particles. Increasing numbers of kneading elements led to high shear and prolonged residence time, which acted to enhance the distribution of liquid and feeding materials. The bimodal size distributions considered to be characteristic of twin screw granulation were primarily ascribed to the breakage of relatively large granules by the kneading elements.

Authors+Show Affiliations

Department of Chemical and Biological Engineering, University of Sheffield, Mappin Street, Sheffield S1 3JD, UK; Pharmaceutical Development, AstraZeneca, Charter Way, Macclesfield SK10 2NA, UK.Pharmaceutical Development, AstraZeneca, Charter Way, Macclesfield SK10 2NA, UK.Global Engineering, AstraZeneca, Alderley Park, Macclesfield SK10 4TF, UK.Pharmaceutical Development, AstraZeneca, Charter Way, Macclesfield SK10 2NA, UK.Department of Chemical and Biological Engineering, University of Sheffield, Mappin Street, Sheffield S1 3JD, UK. Electronic address: a.d.salman@sheffield.ac.uk.

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25124058

Citation

Yu, Shen, et al. "Granulation of Increasingly Hydrophobic Formulations Using a Twin Screw Granulator." International Journal of Pharmaceutics, vol. 475, no. 1-2, 2014, pp. 82-96.
Yu S, Reynolds GK, Huang Z, et al. Granulation of increasingly hydrophobic formulations using a twin screw granulator. Int J Pharm. 2014;475(1-2):82-96.
Yu, S., Reynolds, G. K., Huang, Z., de Matas, M., & Salman, A. D. (2014). Granulation of increasingly hydrophobic formulations using a twin screw granulator. International Journal of Pharmaceutics, 475(1-2), 82-96. https://doi.org/10.1016/j.ijpharm.2014.08.015
Yu S, et al. Granulation of Increasingly Hydrophobic Formulations Using a Twin Screw Granulator. Int J Pharm. 2014 Nov 20;475(1-2):82-96. PubMed PMID: 25124058.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Granulation of increasingly hydrophobic formulations using a twin screw granulator. AU - Yu,Shen, AU - Reynolds,Gavin K, AU - Huang,Zhenyu, AU - de Matas,Marcel, AU - Salman,Agba D, Y1 - 2014/08/12/ PY - 2014/04/12/received PY - 2014/08/07/revised PY - 2014/08/09/accepted PY - 2014/8/16/entrez PY - 2014/8/16/pubmed PY - 2015/8/4/medline KW - Component distribution KW - Hydrophobicity KW - Liquid distribution KW - Number of kneading elements KW - Twin screw granulation KW - Wet granule sizing SP - 82 EP - 96 JF - International journal of pharmaceutics JO - Int J Pharm VL - 475 IS - 1-2 N2 - The application of twin screw granulation in the pharmaceutical industry has generated increasing interest due to its suitability for continuous processing. However, an understanding of the impact of formulation properties such as hydrophobicity on intermediate and finished product quality has not yet been established. Hence, the current work investigated the granulation behaviour of three formulations containing increasing amounts of hydrophobic components using a Consigma™-1 twin screw granulator. Process conditions including powder feed rate, liquid to solid ratio, granulation liquid composition and screw configuration were also evaluated. The size of the wet granules was measured in order to enable exploration of granulation behaviour in isolation without confounding effects from downstream processes such as drying. The experimental observations indicated that the granulation process was not sensitive to the powder feed rate. The hydrophobicity led to heterogeneous liquid distribution and hence a relatively large proportion of un-wetted particles. Increasing numbers of kneading elements led to high shear and prolonged residence time, which acted to enhance the distribution of liquid and feeding materials. The bimodal size distributions considered to be characteristic of twin screw granulation were primarily ascribed to the breakage of relatively large granules by the kneading elements. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/25124058/Granulation_of_increasingly_hydrophobic_formulations_using_a_twin_screw_granulator_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(14)00581-X DB - PRIME DP - Unbound Medicine ER -