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A new expert systems (SeDeM Diagram) for control batch powder formulation and preformulation drug products

Authors
Journal
European Journal of Pharmaceutics and Biopharmaceutics
0939-6411
Publisher
Elsevier
Publication Date
Volume
64
Issue
3
Identifiers
DOI: 10.1016/j.ejpb.2006.06.008
Keywords
  • Expert System
  • Preformulation
  • Formulation
  • Bulk Density (Da)
  • Tapped Density (Dc)
  • Inter-Particle Porosity (Ie)
  • Angle Of Repose (α)
  • Flowability (T″)
  • Particle Size (%Pf)
  • Direct Compression (Dc)
Disciplines
  • Mathematics
  • Pharmacology

Abstract

Abstract The new SeDeM Method is proposed for testing the batch-to-batch reproducibility of the same active pharmaceutical ingredient (API) in powder form. The procedure describes the study of the galenic properties of substances in powder form in terms of the applicability of direct compression technology. Through experimental determination of the SeDeM Method parameters, and their subsequent mathematical treatment and graphical expression (SeDeM Diagram), three batches of the same API were analysed to determine whether it was suitable for direct compression. Batch-to-batch reproducibility of the results was verified. It was concluded that the SeDeM Method is suitable for testing batch-to-batch reproducibility of characteristics in powdered APIs substances. The results obtained confirm that the SeDeM Method is a useful, effective tool for drug-preformulation studies providing the pharmacotechnical data required when formulating a drug in tablet form. In addition, the results were effective for defining the most appropriate manufacturing technology.

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