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Cold extrusion as a continuous single-step granulation and tabletting process.

E I Keleb1, A Vermeire, C Vervaet

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

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|October 26, 2001
PubMed
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Cold extrusion offers a novel, continuous granulation and tabletting method for pharmaceutical ingredients. This technique, particularly for alpha-lactose monohydrate, yields tablets with favorable mechanical and disintegration properties, suitable for poorly compactible drugs.

Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Traditional tabletting methods face challenges with poorly compactible pharmaceutical ingredients.
  • Continuous manufacturing processes are increasingly sought after in pharmaceutical production.

Purpose of the Study:

  • To investigate cold extrusion as a viable continuous granulation and tabletting technique.
  • To evaluate the impact of formulation and process parameters on cold-extruded tablets.
  • To assess the suitability of cold extrusion for ingredients with poor compaction properties.

Main Methods:

  • Twin-screw extrusion was used to produce extrudates from alpha-lactose monohydrate, PVP, and hydrochlorothiazide.
  • Extrudates were manually cut into tablets and dried.
  • Tablet properties including tensile strength, friability, disintegration time, and porosity were evaluated.

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  • Formulation variables (water content, PVP, drug) and process variables (screw speed, feed rate) were optimized.

    • Main Results:

    • Cold extrusion proved feasible for continuous tablet production, with formulation and process parameters influencing feasibility but minimally affecting tablet properties under optimal conditions.
    • Tablets exhibited high tensile strength (>0.7 MPa without PVP, >1.5 MPa with PVP) and low friability (<1.0% without PVP, <0.9% with PVP).
    • Disintegration times were favorable (<1 min without PVP, <8 min with PVP), and extrudates showed higher porosity than conventional tablets.

    Conclusions:

    • Cold extrusion is a promising single-step granulation/tabletting technique for alpha-lactose monohydrate, suitable for poorly compactible materials.
    • The higher porosity of cold-extruded tablets may benefit formulations with poor disintegration characteristics.
    • This method presents an alternative tablet production technique for challenging pharmaceutical ingredients.