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Co-extrusion as manufacturing technique for fixed-dose combination mini-matrices.

L Dierickx1, L Saerens, A Almeida

  • 1Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|April 17, 2012
PubMed
Summary

This study developed a novel multilayer mini-tablet using co-extrusion for controlled drug delivery. The innovative dosage form successfully combined sustained release metoprolol tartrate and immediate release hydrochlorothiazide with good in vitro and in vivo performance.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Developing advanced dosage forms is crucial for improving patient compliance and therapeutic efficacy.
  • Multilayer drug delivery systems offer potential for combining drugs with different release profiles.
  • Co-extrusion is a promising manufacturing technique for creating complex pharmaceutical structures.

Purpose of the Study:

  • To develop a multilayer (core/coat) dosage form using co-extrusion for distinct drug release profiles.
  • To incorporate sustained release metoprolol tartrate (MPT) in the core and immediate release hydrochlorothiazide (HCT) in the coat.
  • To evaluate the processability, drug release, and in vivo performance of the developed formulation.

Main Methods:

  • Screening of thermoplastic polymers for co-extrusion suitability.
  • Hot-melt extrusion and co-extrusion of polycaprolactone (core) and polyethylene oxide (coat) with MPT and HCT.
  • In vitro drug release studies for HCT and MPT.
  • Characterization using Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD), and Raman spectroscopy.
  • In vivo study comparing the experimental formulation with a reference tablet.

Main Results:

  • Successful co-extrusion of a multilayer mini-tablet (3 mm core diameter, 0.5 mm coat thickness) with good layer adhesion.
  • Complete release of HCT within 30 minutes from the coat.
  • Sustained release of MPT over 24 hours from the core (55% at 4h, 70% at 8h, 85% at 12h, 100% at 24h).
  • MPT remained crystalline, while HCT was dissolved in the polyethylene oxide matrix.
  • No significant difference in in vivo performance compared to the reference formulation.

Conclusions:

  • Co-extrusion is an effective method for producing multilayer fixed-dose combination mini-tablets.
  • The developed polycaprolactone/polyethylene oxide formulation provides both immediate and sustained drug release.
  • The mini-tablets demonstrate good in vitro and in vivo performance, offering a viable alternative to conventional tablets.