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A comparative study of the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation.
Pharm Dev Technol. 2019 Mar; 24(3):314-322.PD

Abstract

The influence of particle morphology and size of alpha-lactose monohydrate on dry granules and tablets was studied. Four different morphologies were investigated: Two grades of primary crystals, which differed in their particle size and structure (compact crystals vs. agglomerates). The materials were roll compacted at different specific compaction forces and changes in the particle size distribution and the specific surface area were measured. Afterwards, two fractions of granules were pressed to tablets and the tensile strength was compared to that from tablets compressed from the raw materials. The specific surface area was increased induced by roll compaction/dry granulation for all materials. At increased specific compaction forces, the materials showed sufficient size enlargement. The morphology of lactose determined the strength of direct compressed tablets. In contrast, the strength of granule tablets was leveled by the previous compression step during roll compaction/dry granulation. Thus, the tensile strength of tablets compressed directly from the powder mixtures determined whether materials exhibited a loss in tabletability after roll compaction/dry granulation or not. The granule size had only a slight influence on the strength of produced tablets. In some cases, the fraction of smaller granules showed a higher tensile strength compared to the larger fraction.

Authors+Show Affiliations

a Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University , Duesseldorf , Germany.a Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University , Duesseldorf , Germany.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

29757067

Citation

Grote, Simon, and Peter Kleinebudde. "A Comparative Study of the Influence of Alpha-lactose Monohydrate Particle Morphology On Granule and Tablet Properties After Roll Compaction/dry Granulation." Pharmaceutical Development and Technology, vol. 24, no. 3, 2019, pp. 314-322.
Grote S, Kleinebudde P. A comparative study of the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation. Pharm Dev Technol. 2019;24(3):314-322.
Grote, S., & Kleinebudde, P. (2019). A comparative study of the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation. Pharmaceutical Development and Technology, 24(3), 314-322. https://doi.org/10.1080/10837450.2018.1476977
Grote S, Kleinebudde P. A Comparative Study of the Influence of Alpha-lactose Monohydrate Particle Morphology On Granule and Tablet Properties After Roll Compaction/dry Granulation. Pharm Dev Technol. 2019;24(3):314-322. PubMed PMID: 29757067.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative study of the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation. AU - Grote,Simon, AU - Kleinebudde,Peter, Y1 - 2018/05/29/ PY - 2018/5/15/pubmed PY - 2019/3/8/medline PY - 2018/5/15/entrez KW - Roll compaction KW - alpha-lactose monohydrate KW - dry granules KW - particle morphology KW - tabletability SP - 314 EP - 322 JF - Pharmaceutical development and technology JO - Pharm Dev Technol VL - 24 IS - 3 N2 - The influence of particle morphology and size of alpha-lactose monohydrate on dry granules and tablets was studied. Four different morphologies were investigated: Two grades of primary crystals, which differed in their particle size and structure (compact crystals vs. agglomerates). The materials were roll compacted at different specific compaction forces and changes in the particle size distribution and the specific surface area were measured. Afterwards, two fractions of granules were pressed to tablets and the tensile strength was compared to that from tablets compressed from the raw materials. The specific surface area was increased induced by roll compaction/dry granulation for all materials. At increased specific compaction forces, the materials showed sufficient size enlargement. The morphology of lactose determined the strength of direct compressed tablets. In contrast, the strength of granule tablets was leveled by the previous compression step during roll compaction/dry granulation. Thus, the tensile strength of tablets compressed directly from the powder mixtures determined whether materials exhibited a loss in tabletability after roll compaction/dry granulation or not. The granule size had only a slight influence on the strength of produced tablets. In some cases, the fraction of smaller granules showed a higher tensile strength compared to the larger fraction. SN - 1097-9867 UR - https://www.unboundmedicine.com/medline/citation/29757067/A_comparative_study_of_the_influence_of_alpha_lactose_monohydrate_particle_morphology_on_granule_and_tablet_properties_after_roll_compaction/dry_granulation_ DB - PRIME DP - Unbound Medicine ER -