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Tableting performance of various mannitol and lactose grades assessed by compaction simulation and chemometrical analysis.

Authors
  • Paul, Shubhajit1
  • Tajarobi, Pirjo2
  • Boissier, Catherine2
  • Sun, Changquan Calvin3
  • 1 Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455, United States. , (United States)
  • 2 Pharmaceutical Sciences, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden. , (Sweden)
  • 3 Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455, United States. Electronic address: [email protected] , (United States)
Type
Published Article
Journal
International journal of pharmaceutics
Publication Date
May 13, 2019
Volume
566
Pages
24–31
Identifiers
DOI: 10.1016/j.ijpharm.2019.05.030
PMID: 31095984
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Mannitol and lactose are commonly used fillers in pharmaceutical tablets, available in several commercial grades that are produced using different manufacturing processes. These grades significantly differ in particulate and powder properties that impact tablet manufacturability. Choice of sub-optimum type or grade of excipient in tablet formulation can lead to manufacturing problems and difficulties, which are magnified during a continuous manufacturing process. Previous characterization of tableting performance of these materials was limited in scope and under conditions not always realistic to the commercial production of tablets. This work seeks to comprehensively characterize the compaction properties of 11 mannitol and 5 lactose grades using a compaction simulator at both slow and fast tableting speeds. These include tabletability, compressibility, tablet brittleness, die-wall stress transmission, and strain rate sensitivity. A chemometrical analysis of data, using the partial least square technique, was performed to construct a model to provide accurate prediction of tablet tensile strength for mannitol grades. Such knowledge facilitates the selection of suitable tablet filler to attain high quality tablet products. Copyright © 2019 Elsevier B.V. All rights reserved.

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