Preparation and physicochemical characterization of matrix pellets containing APIs with different solubility via extrusion process

Diána Hegyesi, Markus Thommes, Peter Kleinebudde, Tamás Sovány, Péter Kása, András Kelemen, K. Pintye-Hódi, Géza Regdon

Research output: Contribution to journalArticle

Abstract

In this study, a multiparticulate matrix system was produced, containing two different active pharmaceutical ingredients (APIs): enalapril-maleate and hydrochlorothiazide. The critical control points of the process were investigated by means of factorial design. Beside the generally used microcrystalline cellulose, ethylcellulose was used as matrix former to achieve modified drug release ensured by diffusion. The matrix pellets were made by extrusion-spheronization using a twin-screw extruder. Some pellet properties (aspect ratio, 10% interval fraction, hardness, deformation process) were determined. The aim of our study was to investigate how the two different APIs with different solubility and particle size influence the process. The amount of the granulation liquid plays a key role in the pellet shaping. A higher liquid feed rate is preferred in the pelletization process.

Original languageEnglish
Pages (from-to)458-464
Number of pages7
JournalDrug Development and Industrial Pharmacy
Volume43
Issue number3
DOIs
Publication statusPublished - Mar 4 2017

Keywords

  • Enalapril-maleate
  • extrusion
  • hydrochlorothiazide
  • multiparticulate matrix system
  • pellets
  • spheronization

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology
  • Drug Discovery
  • Organic Chemistry

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