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Rapid formulation screening with a Multipart Microscale Fluid bed Powder processor.

Niina Kivikero1, Matti Murtomaa, Osmo Antikainen

  • 1Industrial Pharmacy, University of Helsinki, Finland. niina.kivikero@helsinki.fi

Pharmaceutical Development and Technology
|April 15, 2010
PubMed
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This study demonstrates rapid, small-scale granulation using a miniaturized fluid bed processor and electrostatic atomization. The method efficiently produced varied granules, though analytical challenges for small batches remain.

Area of Science:

  • Pharmaceutical Technology
  • Process Engineering

Background:

  • Early formulation screening is crucial for drug development.
  • Miniaturized devices offer advantages for small-scale studies.
  • Electrostatic atomization is a viable granulation technique.

Purpose of the Study:

  • To evaluate a miniaturized fluid bed processor for early formulation screening.
  • To investigate granule properties produced via electrostatic atomization.
  • To assess the feasibility of rapid screening with limited material.

Main Methods:

  • Granulation of eight batches using a Multipart Microscale Fluid bed Powder processor (MMFP) with electrostatic atomization.
  • Use of acetylsalicylic acid as API and lactose, microcrystalline cellulose, and polyvinylpyrrolidone as excipients.

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  • Analysis of granule size distribution, friability, and compressibility; multivariate data analysis.

    • Main Results:

    • Successful generation of granules with varying compositions using MMFP.
    • Consistent process conditions yielded reliable and logical results.
    • Acquisition of meaningful data from small material quantities.

    Conclusions:

    • The MMFP with electrostatic atomization enables rapid, small-scale formulation screening.
    • The system is effective for generating diverse granules efficiently.
    • Developing suitable analytical methods for small batches is a key challenge.