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Extrusion granulation and high shear granulation of different grades of lactose and highly dosed drugs: a comparative study.
Drug Dev Ind Pharm. 2004 Jul; 30(6):679-91.DD

Abstract

Formulations containing different lactose grades, paracetamol, and cimetidine were granulated by extrusion granulation and high shear granulation. Granules were evaluated for yield, friability, and compressibility. Tablets were prepared from those granules and evaluated for tensile strength, friability, disintegration time, and dissolution. The different lactose grades had an important effect on the extrusion granulation process. Particle size and morphology affected powder feeding and power consumption, but had only a minor influence on the granule and tablet properties obtained by extrusion granulation. In contrast, the lactose grades had a major influence on the granule properties obtained by high shear granulation. Addition of polyvinylpyrrolidone (PVP) was required to process pure paracetamol and cimetidine by high shear granulation, whereas it was feasible to granulate these drugs without PVP by extrusion granulation. Granules prepared by extrusion granulation exhibited a higher yield and a lower friability than those produced by high shear granulation. Paracetamol and cimetidine tablets compressed from granules prepared by extrusion granulation showed a higher tensile strength, lower friability, and lower disintegration time than those prepared from granules produced by high shear granulation. Paracetamol tablets obtained via extrusion granulation exhibited faster dissolution than those obtained via high shear granulation. For all lactose grades studied, extrusion granulation resulted in superior granule and tablet properties in comparison with those obtained by high shear granulation. These results indicate that extrusion granulation is more efficient than high shear granulation.

Authors+Show Affiliations

Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15285342

Citation

Keleb, E I., et al. "Extrusion Granulation and High Shear Granulation of Different Grades of Lactose and Highly Dosed Drugs: a Comparative Study." Drug Development and Industrial Pharmacy, vol. 30, no. 6, 2004, pp. 679-91.
Keleb EI, Vermeire A, Vervaet C, et al. Extrusion granulation and high shear granulation of different grades of lactose and highly dosed drugs: a comparative study. Drug Dev Ind Pharm. 2004;30(6):679-91.
Keleb, E. I., Vermeire, A., Vervaet, C., & Remon, J. P. (2004). Extrusion granulation and high shear granulation of different grades of lactose and highly dosed drugs: a comparative study. Drug Development and Industrial Pharmacy, 30(6), 679-91.
Keleb EI, et al. Extrusion Granulation and High Shear Granulation of Different Grades of Lactose and Highly Dosed Drugs: a Comparative Study. Drug Dev Ind Pharm. 2004;30(6):679-91. PubMed PMID: 15285342.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Extrusion granulation and high shear granulation of different grades of lactose and highly dosed drugs: a comparative study. AU - Keleb,E I, AU - Vermeire,A, AU - Vervaet,C, AU - Remon,Jean Paul, PY - 2004/8/3/pubmed PY - 2004/9/29/medline PY - 2004/8/3/entrez SP - 679 EP - 91 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 30 IS - 6 N2 - Formulations containing different lactose grades, paracetamol, and cimetidine were granulated by extrusion granulation and high shear granulation. Granules were evaluated for yield, friability, and compressibility. Tablets were prepared from those granules and evaluated for tensile strength, friability, disintegration time, and dissolution. The different lactose grades had an important effect on the extrusion granulation process. Particle size and morphology affected powder feeding and power consumption, but had only a minor influence on the granule and tablet properties obtained by extrusion granulation. In contrast, the lactose grades had a major influence on the granule properties obtained by high shear granulation. Addition of polyvinylpyrrolidone (PVP) was required to process pure paracetamol and cimetidine by high shear granulation, whereas it was feasible to granulate these drugs without PVP by extrusion granulation. Granules prepared by extrusion granulation exhibited a higher yield and a lower friability than those produced by high shear granulation. Paracetamol and cimetidine tablets compressed from granules prepared by extrusion granulation showed a higher tensile strength, lower friability, and lower disintegration time than those prepared from granules produced by high shear granulation. Paracetamol tablets obtained via extrusion granulation exhibited faster dissolution than those obtained via high shear granulation. For all lactose grades studied, extrusion granulation resulted in superior granule and tablet properties in comparison with those obtained by high shear granulation. These results indicate that extrusion granulation is more efficient than high shear granulation. SN - 0363-9045 UR - https://www.unboundmedicine.com/medline/citation/15285342/Extrusion_granulation_and_high_shear_granulation_of_different_grades_of_lactose_and_highly_dosed_drugs:_a_comparative_study_ L2 - https://www.tandfonline.com/doi/full/10.1081/ddc-120039338 DB - PRIME DP - Unbound Medicine ER -