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Related Experiment Videos

Oral controlled release optimization of pellets prepared by extrusion-spheronization processing.

R Bianchini1, C Vecchio

  • 1Farmitalia Carlo Erba, Galenical Development Dpt., Milano, Italy.

Farmaco (Societa Chimica Italiana : 1989)
|June 1, 1989
PubMed
Summary

Controlled release Indobufen capsules were developed using extrusion-spheronization and film coating. Optimized formulations achieved desired in vitro drug release profiles, demonstrating stability over time.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • High-dosage controlled release formulations are crucial for therapeutic efficacy.
  • Multiple-unit dosage forms offer advantages in drug release predictability and safety.
  • Indobufen is a non-steroidal anti-inflammatory drug requiring optimized delivery.

Purpose of the Study:

  • To develop controlled-release multiple-unit dosage forms of Indobufen.
  • To optimize drug release profiles through film coating strategies.
  • To evaluate the impact of formulation variables and coating techniques on drug release and stability.

Main Methods:

  • Preparation of spherical granules using extrusion-spheronization.
  • Film coating with polymeric membranes from organic solutions (pan coating) and aqueous dispersions (air suspension coating).

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  • Evaluation of formulation parameters (drug particle size, drug/binder ratio, extruder screen size) and stability testing.

    • Main Results:

    • Extrusion-spheronization successfully produced spherical granules with reproducible physical properties.
    • Film coating with varying polymer thicknesses and types controlled Indobufen release rates.
    • Both organic solvent-based and aqueous dispersion coating methods yielded promising in vitro release profiles.
    • Accelerated stability studies indicated that storage parameters influenced the drug release profile over time.

    Conclusions:

    • Controlled-release Indobufen capsules can be effectively manufactured using extrusion-spheronization and film coating.
    • The choice of coating material, thickness, and application technique significantly impacts drug release kinetics.
    • The developed formulations demonstrate potential for stable, controlled drug delivery.