<p>Excipients are essential components within pharmaceutical formulations that are used to enhance properties such as the binding, disintegration, preservation, and patient friendliness of common dosage forms such as tablets, capsules, and inhalers. Common excipients such as micro-crystalline cellulose (MCC), dibasic calcium phosphate dihydrate (DCPD), and partially pre-gelatinised corn starch (PGS) therefore play a critical role in the design and production process of both new and existing drug formulations. However, despite the importance of these powders, reference data are not publicly available. This report presents an extensive data set on MCC, DCPD, and PGS&#xa0;which includes detailed information on individual grains, including particle sizes, crushing, and geometries. Using a compaction simulator, the powders and various mixtures thereof were compressed to make tablets, which were later subjected to a wide range of mechanical tests. This data set provides a reference point for the pharmaceutical industry, educators, and process developers alike.</p>

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Characterisation Data of common pharmaceutical excipient Powders and Tablets for Formulation Development

  • Dingeman L. H. van der Haven,
  • Maria Mikoroni,
  • René Jensen,
  • Frederik H. Ørtoft,
  • Jan L. Andreasen,
  • Mia E. Andersen,
  • Daniel Dax,
  • Umair Zafar,
  • Andrew Megarry,
  • Kaisa Naelapää,
  • Ioannis S. Fragkopoulos,
  • James A. Elliott

摘要

Excipients are essential components within pharmaceutical formulations that are used to enhance properties such as the binding, disintegration, preservation, and patient friendliness of common dosage forms such as tablets, capsules, and inhalers. Common excipients such as micro-crystalline cellulose (MCC), dibasic calcium phosphate dihydrate (DCPD), and partially pre-gelatinised corn starch (PGS) therefore play a critical role in the design and production process of both new and existing drug formulations. However, despite the importance of these powders, reference data are not publicly available. This report presents an extensive data set on MCC, DCPD, and PGS which includes detailed information on individual grains, including particle sizes, crushing, and geometries. Using a compaction simulator, the powders and various mixtures thereof were compressed to make tablets, which were later subjected to a wide range of mechanical tests. This data set provides a reference point for the pharmaceutical industry, educators, and process developers alike.