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Preparation of sustained release co-extrudates by hot-melt extrusion and mathematical modelling of in vitro/ in vivo drug release profiles
Ist Teil von
European journal of pharmaceutical sciences, 2008-03, Vol.33 (3), p.282-293
Ort / Verlag
Netherlands: Elsevier B.V
Erscheinungsjahr
2008
Link zum Volltext
Quelle
MEDLINE
Beschreibungen/Notizen
Aim of this work was to develop a cylindrical co-extrudate characterised by an
in vivo sustained release profile by means of a hot-melt extrusion process. Co-extrudate was made up of two concentric extruded matrices: an inner one having a hydrophilic character, based on polyethylene glycol, and an outer one with lipophilic character, based on microcrystalline wax. Both segments contained theophylline as a model drug. A screening between several devices differing for dimensions (diameter and length) and relative proportions of the inner and outer part was carried out on the basis of their
in vitro drug release and the release mechanism was studied by means of a mathematical model. The co-extrudate exhibiting the desired sustained release was selected for
in vivo bioavailability studies.
In vivo studies confirmed the achievement of the purpose of the research, demonstrating the desired release of theophylline on four healthy volunteers. Accordingly, hot-melt extrusion process is a viable method to produce in a single step co-extrudates showing a sustained release. In addition, the developed mathematical model proved to be a reliable descriptor of the both
in vitro and
in vivo experimental data.