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Continuous twin screw granulation: influence of process variables on granule and tablet quality.
Eur J Pharm Biopharm. 2012 Sep; 82(1):205-11.EJ

Abstract

The aim of the current study was to screen theophylline (125 mg) tablets manufactured via twin screw granulation in order to improve process understanding and knowledge of process variables that determine granule and tablet quality. A premix of theophylline anhydrate, α-lactose monohydrate and PVP (ratio: 30/67.5/2.5,w/w) was granulated with demineralized water. Experiments were done using the high-shear wet granulation module (based on twin screw granulation) of the ConsiGma™-25 unit (a continuous tablet manufacturing system) for particle size enlargement. After drying, granules were compressed using a MODUL™ P tablet press (compression force: 10 kN, tablet diameter: 12 mm). Using a D-optimal experimental design, the effect of several process variables (throughput (10-25 kg/h), screw speed (600-950 rpm), screw configuration (number (2, 4, 6 and 12) and angle (30°, 60° and 90°) of kneading elements), barrel temperature (25-40°C) and method of binder addition (dry versus wet)) on the granulation process (torque and temperature increase in barrel wall), granule (particle size distribution, friability and flowability) and tablet (tensile strength, porosity, friability, disintegration time and dissolution) quality was evaluated. The results showed that the quality of granules and tablets can be optimized by adjusting specific process variables (number of kneading elements, barrel temperature and binder addition method) during a granulation process using a continuous twin screw granulator.

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Authors+Show Affiliations

Vercruysse J
Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.
Córdoba Díaz D
No affiliation info available
Peeters E
No affiliation info available
Fonteyne M
No affiliation info available
Delaet U
No affiliation info available
Van Assche I
No affiliation info available
De Beer T
No affiliation info available
Remon JP
No affiliation info available
Vervaet C
No affiliation info available

MeSH

Drug CompoundingExcipientsLactoseParticle SizePorosityPovidoneSolubilityTabletsTemperatureTensile StrengthTheophylline

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22687571

Citation

Vercruysse, J, et al. "Continuous Twin Screw Granulation: Influence of Process Variables On Granule and Tablet Quality." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 82, no. 1, 2012, pp. 205-11.
Vercruysse J, Córdoba Díaz D, Peeters E, et al. Continuous twin screw granulation: influence of process variables on granule and tablet quality. Eur J Pharm Biopharm. 2012;82(1):205-11.
Vercruysse, J., Córdoba Díaz, D., Peeters, E., Fonteyne, M., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., & Vervaet, C. (2012). Continuous twin screw granulation: influence of process variables on granule and tablet quality. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 82(1), 205-11. https://doi.org/10.1016/j.ejpb.2012.05.010
Vercruysse J, et al. Continuous Twin Screw Granulation: Influence of Process Variables On Granule and Tablet Quality. Eur J Pharm Biopharm. 2012;82(1):205-11. PubMed PMID: 22687571.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous twin screw granulation: influence of process variables on granule and tablet quality. AU - Vercruysse,J, AU - Córdoba Díaz,D, AU - Peeters,E, AU - Fonteyne,M, AU - Delaet,U, AU - Van Assche,I, AU - De Beer,T, AU - Remon,J P, AU - Vervaet,C, Y1 - 2012/06/09/ PY - 2012/02/13/received PY - 2012/04/21/revised PY - 2012/05/21/accepted PY - 2012/6/13/entrez PY - 2012/6/13/pubmed PY - 2013/2/6/medline SP - 205 EP - 11 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 82 IS - 1 N2 - The aim of the current study was to screen theophylline (125 mg) tablets manufactured via twin screw granulation in order to improve process understanding and knowledge of process variables that determine granule and tablet quality. A premix of theophylline anhydrate, α-lactose monohydrate and PVP (ratio: 30/67.5/2.5,w/w) was granulated with demineralized water. Experiments were done using the high-shear wet granulation module (based on twin screw granulation) of the ConsiGma™-25 unit (a continuous tablet manufacturing system) for particle size enlargement. After drying, granules were compressed using a MODUL™ P tablet press (compression force: 10 kN, tablet diameter: 12 mm). Using a D-optimal experimental design, the effect of several process variables (throughput (10-25 kg/h), screw speed (600-950 rpm), screw configuration (number (2, 4, 6 and 12) and angle (30°, 60° and 90°) of kneading elements), barrel temperature (25-40°C) and method of binder addition (dry versus wet)) on the granulation process (torque and temperature increase in barrel wall), granule (particle size distribution, friability and flowability) and tablet (tensile strength, porosity, friability, disintegration time and dissolution) quality was evaluated. The results showed that the quality of granules and tablets can be optimized by adjusting specific process variables (number of kneading elements, barrel temperature and binder addition method) during a granulation process using a continuous twin screw granulator. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/22687571/Continuous_twin_screw_granulation:_influence_of_process_variables_on_granule_and_tablet_quality_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(12)00177-4 DB - PRIME DP - Unbound Medicine ER -