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Continuous twin screw extrusion for the wet granulation of lactose.
Int J Pharm. 2002 Jun 04; 239(1-2):69-80.IJ

Abstract

The suitability of continuous twin screw extrusion for the wet granulation of alpha-lactose monohydrate was studied and compared with conventional high shear granulation. The influence of process parameters (screw speed and total input rate) and formulation variables (water and polyvinylpyrrolidone (PVP) concentration) on the properties of granules (yield, particle size distribution, friability and compressibility) and tablets (tablet tensile strength, friability and disintegration time) was investigated. Variation of the formulation and process parameters had a major effect on the process feasibility. Optimization of these parameters is required to allow continuous processing and to ensure a high yield. Total input rate, screw speed and water concentration had a minor influence on the granule and the tablet properties. The addition of PVP had no major influence on the granule properties, but significantly affected the tablet characteristics. For granules formulated with and without PVP a yield above 50%, a friability below 30% and a compressibility below 15% was obtained. Tablets without PVP showed a tensile strength below 0.6 MPa, a friability above 1% and a disintegration time below 3 min, whereas tablets with PVP showed a tensile strength above 0.6 MPa, a friability below 1% and a disintegration time ranging from 8 to 15 min. High shear granulation was only possible when PVP was added and it required a higher amount of water. It was concluded that wet granulation of alpha-lactose monohydrate using continuous twin screw extrusion is a robust process and might offer a suitable alternative for high shear granulation in the pharmaceutical industry.

Authors+Show Affiliations

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

Pub Type(s)

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

Language

eng

PubMed ID

12052692

Citation

Keleb, E I., et al. "Continuous Twin Screw Extrusion for the Wet Granulation of Lactose." International Journal of Pharmaceutics, vol. 239, no. 1-2, 2002, pp. 69-80.
Keleb EI, Vermeire A, Vervaet C, et al. Continuous twin screw extrusion for the wet granulation of lactose. Int J Pharm. 2002;239(1-2):69-80.
Keleb, E. I., Vermeire, A., Vervaet, C., & Remon, J. P. (2002). Continuous twin screw extrusion for the wet granulation of lactose. International Journal of Pharmaceutics, 239(1-2), 69-80.
Keleb EI, et al. Continuous Twin Screw Extrusion for the Wet Granulation of Lactose. Int J Pharm. 2002 Jun 4;239(1-2):69-80. PubMed PMID: 12052692.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous twin screw extrusion for the wet granulation of lactose. AU - Keleb,E I, AU - Vermeire,A, AU - Vervaet,C, AU - Remon,J P, PY - 2002/6/8/pubmed PY - 2002/7/24/medline PY - 2002/6/8/entrez SP - 69 EP - 80 JF - International journal of pharmaceutics JO - Int J Pharm VL - 239 IS - 1-2 N2 - The suitability of continuous twin screw extrusion for the wet granulation of alpha-lactose monohydrate was studied and compared with conventional high shear granulation. The influence of process parameters (screw speed and total input rate) and formulation variables (water and polyvinylpyrrolidone (PVP) concentration) on the properties of granules (yield, particle size distribution, friability and compressibility) and tablets (tablet tensile strength, friability and disintegration time) was investigated. Variation of the formulation and process parameters had a major effect on the process feasibility. Optimization of these parameters is required to allow continuous processing and to ensure a high yield. Total input rate, screw speed and water concentration had a minor influence on the granule and the tablet properties. The addition of PVP had no major influence on the granule properties, but significantly affected the tablet characteristics. For granules formulated with and without PVP a yield above 50%, a friability below 30% and a compressibility below 15% was obtained. Tablets without PVP showed a tensile strength below 0.6 MPa, a friability above 1% and a disintegration time below 3 min, whereas tablets with PVP showed a tensile strength above 0.6 MPa, a friability below 1% and a disintegration time ranging from 8 to 15 min. High shear granulation was only possible when PVP was added and it required a higher amount of water. It was concluded that wet granulation of alpha-lactose monohydrate using continuous twin screw extrusion is a robust process and might offer a suitable alternative for high shear granulation in the pharmaceutical industry. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/12052692/Continuous_twin_screw_extrusion_for_the_wet_granulation_of_lactose_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378517302000522 DB - PRIME DP - Unbound Medicine ER -