Comparative analyses of flow and compaction properties of diverse mannitol and lactose grades

Shubhajit Paul, Shao Yu Chang, Jiangnan Dun, Wei Jhe Sun, Kunlin Wang, Pirjo Tajarobi, Catherine Boissier, Changquan Calvin Sun

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

Appropriate selection of excipient grade during tablet formulation development depends on thorough knowledge in their compaction and flow properties. Each chemically unique pharmaceutical excipient is usually available in several commercial grades that are widely different in powder properties, which influence their performance for a specific formulation application. In this work, 11 grades of mannitol were systematically characterized, in terms of their particulate, flow and tableting properties, and compared against 5 grades of lactose. Principal component analysis (PCA) identified significant correlations among selected variables, such as particle size, surface area, flowability, wall friction, plasticity parameter, tensile strength, and tablet brittleness. PCA also revealed similar grades of the two excipients, which may be used to select replacement grade, if needed, based on similarity in their overall properties.

Original languageEnglish (US)
Pages (from-to)39-49
Number of pages11
JournalInternational journal of pharmaceutics
Volume546
Issue number1-2
DOIs
StatePublished - Jul 30 2018

Bibliographical note

Funding Information:
We thank Sara Solin for the particle surface area measurements. Roquette, Merck, and DFE Pharma are acknowledged for providing Pearlitol, Parteck, and lactose samples, respectively. A portion of this work was carried out in the Minnesota Nano Center which receives partial support from the NSF through the NNCI program. Appendix A

Publisher Copyright:
© 2018 Elsevier B.V.

Keywords

  • Direct compression
  • Lactose
  • Mannitol
  • Powder flow
  • Principal component analysis

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