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Related Experiment Videos

Scaleup of a high-shear granulation process using a normalized impeller work parameter.

P J Sirois1, G D Craig

  • 1Pharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. Sirois_Paul_J@Lilly.com

Pharmaceutical Development and Technology
|August 10, 2000
PubMed
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This study introduces a method to predict granulation endpoints in microcrystalline cellulose formulations by measuring impeller work. This approach ensures consistent tablet properties across different manufacturing scales and equipment.

Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering
  • Materials Science

Background:

  • High-shear granulation is crucial for pharmaceutical manufacturing.
  • Accurate endpoint determination is vital for consistent product quality.
  • Current methods may lack scalability and equipment independence.

Purpose of the Study:

  • To evaluate a novel method for identifying granulation endpoints.
  • To establish a scalable and equipment-independent granulation endpoint prediction.
  • To correlate impeller work with critical quality attributes of granulated materials.

Main Methods:

  • Impeller watt meters were calibrated in situ for accurate power measurement.
  • Impeller power (watts) versus time (seconds) was integrated to calculate work of granulation (watt-seconds).

Related Experiment Videos

  • Work values were normalized by dry powder weight (watt-sec/g) for scale-up.

    • Main Results:

    • Granulation endpoints were accurately predicted across manufacturing scales (5.0 L to 150 L).
    • Work of granulation correlated quantitatively with cohesion index, particle size, and bulk/tapped densities.
    • Method demonstrated functional equivalence across different equipment and impeller speeds.

    Conclusions:

    • Impeller work is a reliable, scalable, and equipment-independent parameter for determining granulation endpoints.
    • This method enhances process understanding and control in pharmaceutical granulation.
    • The work of granulation offers a robust metric for predicting tablet properties.