The development of direct extrusion-injection moulded zein matrices as novel oral controlled drug delivery systems

Bouman, Jacob, Belton, Peter, Venema, Paul, van der Linden, Erik, de Vries, Renko and Qi, Sheng ORCID: https://orcid.org/0000-0003-1872-9572 (2015) The development of direct extrusion-injection moulded zein matrices as novel oral controlled drug delivery systems. Pharmaceutical Research, 32 (8). pp. 2775-2786. ISSN 0724-8741

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Abstract

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°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.

Item Type:	Article
Uncontrolled Keywords:	controlled release,diffusion mechanism,dissolution kinetics modelling,hot melt extrusion-injection moulding,zein
Faculty \ School:	Faculty of Science > School of Chemistry (former - to 2024) Faculty of Science > School of Pharmacy (former - to 2024)
UEA Research Groups:	Faculty of Science > Research Groups > Drug Delivery and Pharmaceutical Materials (former - to 2017) Faculty of Science > Research Groups > Pharmaceutical Materials and Soft Matter
Depositing User:	Pure Connector
Date Deposited:	24 Jul 2015 21:50
Last Modified:	31 Oct 2024 00:38
URI:	https://ueaeprints.uea.ac.uk/id/eprint/53543
DOI:	10.1007/s11095-015-1663-9

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