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Single process for manufacturing spheres with a lipid base (HCO).

Pascale Gauthier1, Jean-Michel Cardot, Erick Beyssac

  • 1Biopharmacy Department, Faculty of Pharmacy, Place Henri Dunant, Clermont-Ferrand, France. Pascale.Gauthier@u-clermont1.fr

Pharmaceutical Development and Technology
|December 24, 2010
PubMed
Summary

A novel single pot process using rotary fluid bed granulation with lipid fillers efficiently produces pharmaceutical spheres. Key parameters like spraying time and liquid weight control sphere quality for capsule or tablet formulation.

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Chemical Engineering

Background:

  • Pharmaceutical pellets and spheres are crucial dosage forms.
  • Current manufacturing processes can be challenging to automate.
  • Lipid-based formulations offer unique properties for drug delivery.

Purpose of the Study:

  • To describe and evaluate a single pot process for sphere manufacture.
  • To investigate the use of hydrogenated castor oil as a lipid matrix filler.
  • To assess the influence of formulation and process parameters on sphere quality.

Main Methods:

  • Rotary fluid bed granulation in a single pot setup.
  • Utilized hydrogenated castor oil as the matrix filler and theophylline as a tracer.

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  • Employed in vitro tests to evaluate sphere feasibility and quality.

    • Main Results:

    • The rotary fluid bed granulation process was successfully applied for sphere production.
    • Hydrogenated castor oil proved effective as a matrix filler.
    • Spraying time and the weight of sprayed liquid were identified as critical parameters influencing sphere quality.

    Conclusions:

    • The described single pot process offers an efficient method for manufacturing pharmaceutical spheres.
    • This technology allows for the production of spheres suitable for direct capsule filling or tablet compression.
    • Optimization of spraying time and liquid weight is essential for consistent sphere quality.