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High-throughput blend segregation evaluation using automated powder dispensing technology.

Eva L Wu1, Parind M Desai2, Syed A M Zaidi1

  • 1Analytical Platforms and Platform Modernization, CMC Analytical, GlaxoSmithKline (GSK) R&D, Collegeville, Pennsylvania, USA.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|January 11, 2021
PubMed
Summary
This summary is machine-generated.

Quantifying active pharmaceutical ingredient (API) blend segregation is challenging. A new high-throughput workflow using automated powder dispensing predicts segregation risk in early drug development with minimal API quantities.

Keywords:
Automated powder dispensing technologyHigh-throughputLab automationPharmaceutical blendSegregation

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Product Development
  • Materials Science

Background:

  • Quantifying blend segregation propensity for Active Pharmaceutical Ingredients (APIs) is complex due to intricate variable interactions.
  • Early drug product development faces challenges in predicting blend segregation with limited API availability.

Purpose of the Study:

  • To develop a high-throughput segregation risk prediction workflow for early drug product development.
  • To enable segregation evaluation using minimal API quantities (~7g).

Main Methods:

  • Utilized automated powder dispensing technology, liquid handling robots, and High-Performance Liquid Chromatography (HPLC).
  • Employed a well-plate autosampler for sample preparation and analysis of API blends.
  • Evaluated blends with varying API concentrations and particle sizes.

Main Results:

  • The workflow successfully evaluated segregation in small API blend quantities, significantly less than traditional methods.
  • Segregation patterns were explained by vibration-induced percolation phenomena.
  • Quantitative segregation risk was determined using relative standard deviation (RSD), aligning with large-scale studies.

Conclusions:

  • The developed workflow offers increased throughput, a simplified walk-up method, and reduced equipment footprint and API exposure.
  • Provides crucial insights for optimizing particle size distribution, formulation constituents, and processing steps in early-stage drug development with limited API.
  • Facilitates robust segregation risk assessment crucial for successful drug product formulation.