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Impact of Different Dry and Wet Granulation Techniques on Granule and Tablet Properties: A Comparative Study.
J Pharm Sci. 2018 12; 107(12):3143-3152.JP

Abstract

Four granulation techniques were compared evaluating their impact on granule properties and the tablet tensile strength. A common formulation was chosen to be processed with both wet and dry granulation techniques: roll compaction/dry granulation, high-shear granulation, twin-screw granulation, and fluidized-bed granulation. The produced granules were characterized in terms of granule size distribution, X-ray powder diffraction, scanning electron microscopy, porosity, and strength. Granules were tableted, and the tablets were evaluated in terms of tensile strength and mass variation. A particular focus was given to granule strength measurements. Granule strength showed to be strongly affected by the used granulation technique. Moreover, a nonlinear inverse correlation was identified between granule strength and tablet tensile strength. High-shear granulation produced the densest and strongest granules, which presented the lowest tablet tensile strength. Granules manufactured by roll compaction/dry granulation showed no loss in tabletability with the used formulation even for the more compacted and strong granules. Tablets produced by the fluidized-bed granulation showed the best properties in terms of tensile strength and mass variation. However, twin-screw granulation presented comparable results for the specific formulation evaluated in the study, thus revealing a great potential of this technique.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Arndt OR
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany.
Baggio R
Department of Pharmaceutical and Pharmacological Sciences, University of Padua, Via Marzolo 5, 35131 Padua, Italy.
Adam AK
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany.
Harting J
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany.
Franceschinis E
Department of Pharmaceutical and Pharmacological Sciences, University of Padua, Via Marzolo 5, 35131 Padua, Italy.
Kleinebudde P
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany. Electronic address: kleinebudde@hhu.de.

MeSH

Drug CompoundingExcipientsLactoseParticle SizePorosityPowder DiffractionPowdersTabletsTensile StrengthX-Ray Diffraction

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

30244008

Citation

Arndt, Oscar-Rupert, et al. "Impact of Different Dry and Wet Granulation Techniques On Granule and Tablet Properties: a Comparative Study." Journal of Pharmaceutical Sciences, vol. 107, no. 12, 2018, pp. 3143-3152.
Arndt OR, Baggio R, Adam AK, et al. Impact of Different Dry and Wet Granulation Techniques on Granule and Tablet Properties: A Comparative Study. J Pharm Sci. 2018;107(12):3143-3152.
Arndt, O. R., Baggio, R., Adam, A. K., Harting, J., Franceschinis, E., & Kleinebudde, P. (2018). Impact of Different Dry and Wet Granulation Techniques on Granule and Tablet Properties: A Comparative Study. Journal of Pharmaceutical Sciences, 107(12), 3143-3152. https://doi.org/10.1016/j.xphs.2018.09.006
Arndt OR, et al. Impact of Different Dry and Wet Granulation Techniques On Granule and Tablet Properties: a Comparative Study. J Pharm Sci. 2018;107(12):3143-3152. PubMed PMID: 30244008.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of Different Dry and Wet Granulation Techniques on Granule and Tablet Properties: A Comparative Study. AU - Arndt,Oscar-Rupert, AU - Baggio,Roberto, AU - Adam,Anna Kira, AU - Harting,Julia, AU - Franceschinis,Erica, AU - Kleinebudde,Peter, Y1 - 2018/09/19/ PY - 2018/07/30/received PY - 2018/09/04/revised PY - 2018/09/10/accepted PY - 2018/9/24/pubmed PY - 2019/8/17/medline PY - 2018/9/24/entrez KW - dry granulation KW - granule size KW - granule strength KW - tablet KW - tensile strength KW - wet granulation SP - 3143 EP - 3152 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 107 IS - 12 N2 - Four granulation techniques were compared evaluating their impact on granule properties and the tablet tensile strength. A common formulation was chosen to be processed with both wet and dry granulation techniques: roll compaction/dry granulation, high-shear granulation, twin-screw granulation, and fluidized-bed granulation. The produced granules were characterized in terms of granule size distribution, X-ray powder diffraction, scanning electron microscopy, porosity, and strength. Granules were tableted, and the tablets were evaluated in terms of tensile strength and mass variation. A particular focus was given to granule strength measurements. Granule strength showed to be strongly affected by the used granulation technique. Moreover, a nonlinear inverse correlation was identified between granule strength and tablet tensile strength. High-shear granulation produced the densest and strongest granules, which presented the lowest tablet tensile strength. Granules manufactured by roll compaction/dry granulation showed no loss in tabletability with the used formulation even for the more compacted and strong granules. Tablets produced by the fluidized-bed granulation showed the best properties in terms of tensile strength and mass variation. However, twin-screw granulation presented comparable results for the specific formulation evaluated in the study, thus revealing a great potential of this technique. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/30244008/Impact_of_Different_Dry_and_Wet_Granulation_Techniques_on_Granule_and_Tablet_Properties:_A_Comparative_Study_ DB - PRIME DP - Unbound Medicine ER -