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Single-step granulation/tabletting of different grades of lactose: a comparison with high shear granulation and compression.
Eur J Pharm Biopharm. 2004 Jul; 58(1):77-82.EJ

Abstract

The influence of the particle size, particle morphology and crystallinity of lactose on the extrusion properties and on the quality of tablets were investigated using single-step granulation/tabletting as a tabletting technique. Results showed that particle size and type of lactose (alpha-lactose monohydrate, anhydrous beta-lactose and spray dried lactose) affected the powder feeding, the process performance as well as the process capacity. Different grades of lactose yielded tablets with similar tensile strength, but significantly different disintegration time. Single-step granulation/tabletting always yielded tablets with a significantly higher tensile strength and similar or significantly lower disintegration time compared to high shear granulation and compression. The tensile strength of alpha-lactose monohydrate tablets (without and with PVP) did not change during one year of storage at 60% RH-25 degrees C and at 75% RH-40 degrees C, whereas a significant increase in disintegration time was observed. It can be concluded that although the lactose grade affected the performance and the optimal parameters of single-step granulation/tabletting, all lactose grades can be efficiently processed using this technique.

Authors+Show Affiliations

Laboratory of Pharmaceutical Technology, Ghent University, 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

15207540

Citation

Keleb, E I., et al. "Single-step Granulation/tabletting of Different Grades of Lactose: a Comparison With High Shear Granulation and Compression." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 58, no. 1, 2004, pp. 77-82.
Keleb EI, Vermeire A, Vervaet C, et al. Single-step granulation/tabletting of different grades of lactose: a comparison with high shear granulation and compression. Eur J Pharm Biopharm. 2004;58(1):77-82.
Keleb, E. I., Vermeire, A., Vervaet, C., & Remon, J. P. (2004). Single-step granulation/tabletting of different grades of lactose: a comparison with high shear granulation and compression. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 58(1), 77-82.
Keleb EI, et al. Single-step Granulation/tabletting of Different Grades of Lactose: a Comparison With High Shear Granulation and Compression. Eur J Pharm Biopharm. 2004;58(1):77-82. PubMed PMID: 15207540.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single-step granulation/tabletting of different grades of lactose: a comparison with high shear granulation and compression. AU - Keleb,E I, AU - Vermeire,A, AU - Vervaet,C, AU - Remon,J P, PY - 2003/08/28/received PY - 2004/03/03/revised PY - 2004/03/03/accepted PY - 2004/6/23/pubmed PY - 2005/1/19/medline PY - 2004/6/23/entrez SP - 77 EP - 82 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 58 IS - 1 N2 - The influence of the particle size, particle morphology and crystallinity of lactose on the extrusion properties and on the quality of tablets were investigated using single-step granulation/tabletting as a tabletting technique. Results showed that particle size and type of lactose (alpha-lactose monohydrate, anhydrous beta-lactose and spray dried lactose) affected the powder feeding, the process performance as well as the process capacity. Different grades of lactose yielded tablets with similar tensile strength, but significantly different disintegration time. Single-step granulation/tabletting always yielded tablets with a significantly higher tensile strength and similar or significantly lower disintegration time compared to high shear granulation and compression. The tensile strength of alpha-lactose monohydrate tablets (without and with PVP) did not change during one year of storage at 60% RH-25 degrees C and at 75% RH-40 degrees C, whereas a significant increase in disintegration time was observed. It can be concluded that although the lactose grade affected the performance and the optimal parameters of single-step granulation/tabletting, all lactose grades can be efficiently processed using this technique. SN - 0939-6411 UR - https://www.unboundmedicine.com/medline/citation/15207540/Single_step_granulation/tabletting_of_different_grades_of_lactose:_a_comparison_with_high_shear_granulation_and_compression_ DB - PRIME DP - Unbound Medicine ER -
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