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Validation of a continuous granulation process using a twin-screw extruder.
Int J Pharm. 2008 May 22; 356(1-2):224-30.IJ

Abstract

Using twin-screw granulation as particle size enlargement technique, the effect of modifying the screw configuration (number of mixing zones, configuration of kneading block) on granule quality, tablet properties and mixing efficiency was investigated. The amount of oversized agglomerates and yield was significantly influenced by the presence of an extra conveying element at the screw end. Changing the staggering angle of the kneading block significantly affected yield and granule friability. The 90 degrees configuration resulted in a lower yield and granule friability. Disintegration time was the only tablet property significantly influenced by the screw configuration as disintegration was significantly faster when an extra conveying element was placed at the screw end. The influence of tracer addition method (wet vs. dry) on mixing efficiency inside the extruder barrel was investigated by means of different tracers: riboflavin (0.05%) suspended in the granulation liquid and hydrochlorothiazide (2.5%) added separately as powder. Mixing efficiency in function of time and granule size (above and below 1400 microm) was tested using riboflavine sodium phosphate (0.05%) dissolved in the granulation liquid. Since a good mixing efficiency was obtained independent of tracer addition method, tracer solubility, granulation time and granule size, continuous granulation using a twin-screw extruder was identified as a robust process.

Authors+Show Affiliations

Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

18295990

Citation

Van Melkebeke, B, et al. "Validation of a Continuous Granulation Process Using a Twin-screw Extruder." International Journal of Pharmaceutics, vol. 356, no. 1-2, 2008, pp. 224-30.
Van Melkebeke B, Vervaet C, Remon JP. Validation of a continuous granulation process using a twin-screw extruder. Int J Pharm. 2008;356(1-2):224-30.
Van Melkebeke, B., Vervaet, C., & Remon, J. P. (2008). Validation of a continuous granulation process using a twin-screw extruder. International Journal of Pharmaceutics, 356(1-2), 224-30. https://doi.org/10.1016/j.ijpharm.2008.01.012
Van Melkebeke B, Vervaet C, Remon JP. Validation of a Continuous Granulation Process Using a Twin-screw Extruder. Int J Pharm. 2008 May 22;356(1-2):224-30. PubMed PMID: 18295990.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of a continuous granulation process using a twin-screw extruder. AU - Van Melkebeke,B, AU - Vervaet,C, AU - Remon,J P, Y1 - 2008/01/17/ PY - 2007/11/08/received PY - 2008/01/04/revised PY - 2008/01/08/accepted PY - 2008/2/26/pubmed PY - 2008/8/19/medline PY - 2008/2/26/entrez SP - 224 EP - 30 JF - International journal of pharmaceutics JO - Int J Pharm VL - 356 IS - 1-2 N2 - Using twin-screw granulation as particle size enlargement technique, the effect of modifying the screw configuration (number of mixing zones, configuration of kneading block) on granule quality, tablet properties and mixing efficiency was investigated. The amount of oversized agglomerates and yield was significantly influenced by the presence of an extra conveying element at the screw end. Changing the staggering angle of the kneading block significantly affected yield and granule friability. The 90 degrees configuration resulted in a lower yield and granule friability. Disintegration time was the only tablet property significantly influenced by the screw configuration as disintegration was significantly faster when an extra conveying element was placed at the screw end. The influence of tracer addition method (wet vs. dry) on mixing efficiency inside the extruder barrel was investigated by means of different tracers: riboflavin (0.05%) suspended in the granulation liquid and hydrochlorothiazide (2.5%) added separately as powder. Mixing efficiency in function of time and granule size (above and below 1400 microm) was tested using riboflavine sodium phosphate (0.05%) dissolved in the granulation liquid. Since a good mixing efficiency was obtained independent of tracer addition method, tracer solubility, granulation time and granule size, continuous granulation using a twin-screw extruder was identified as a robust process. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/18295990/Validation_of_a_continuous_granulation_process_using_a_twin_screw_extruder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(08)00032-X DB - PRIME DP - Unbound Medicine ER -