The Development of Direct Extrusion-Injection Moulded Zein Matrices as Novel Oral Controlled Drug Delivery Systems

Bouman, J., Belton, P., Venema, P., van der Linden, E., de Vries, R. & Qi, S., Aug-2015, In : Pharmaceutical Research. 32, 8, p. 2775-2786 12 p.

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  • The Development of Direct Extrusion-Injection Moulded Zein Matrices as Novel

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  • Jacob Bouman
  • Peter Belton
  • Paul Venema
  • Erik van der Linden
  • Renko de Vries
  • Sheng Qi

Purpose To evaluate the potential of zein as a sole excipient for controlled release formulations prepared by hot melt extrusion.

Methods Physical mixtures of zein, water and crystalline paracetamol were hot melt extruded (HME) at 80 degrees C and injection moulded (IM) into caplet forms. HME-IM Caplets were characterised using differential scanning calorimetry, ATR-FTIR spectroscopy, scanning electron microscopy and powder X-ray diffraction. Hydration and drug release kinetics of the caplets were investigated and fitted to a diffusion model.

Results For the formulations with lower drug loadings, the drug was found to be in the non-crystalline state, while for the ones with higher drug loadings paracetamol is mostly crystalline. Release was found to be largely independent of drug loading but strongly dependent upon device dimensions, and predominately governed by a Fickian diffusion mechanism, while the hydration kinetics shows the features of Case II diffusion.

Conclusions In this study a prototype controlled release caplet formulation using zein as the sole excipient was successfully prepared using direct HME-IM processing. The results demonstrated the unique advantage of the hot melt extruded zein formulations on the tuneability of drug release rate by alternating the device dimensions.

Original languageEnglish
Pages (from-to)2775-2786
Number of pages12
JournalPharmaceutical Research
Issue number8
Publication statusPublished - Aug-2015


  • controlled release, diffusion mechanism, dissolution kinetics modelling, hot melt extrusion-injection moulding, Zein, SOLID-STATE, DIFFUSION, PROTEIN, ACETAMINOPHEN, PARACETAMOL, RELEASE, HISTORY, FTIR

ID: 22994926