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Highly efficient miniaturized coprecipitation screening (MiCoS) for amorphous solid dispersion formulation

Qingyan Hu1, Duk Soon Choi, Hitesh Chokshi

  • 1pRED Formulation Research, Hoffmann-La Roche, Nutley, NJ, USA. qingyanhu@gmail.com

International Journal of Pharmaceutics
|April 27, 2013
PubMed
Summary

A new high-throughput screening method, miniaturized coprecipitation screening (MiCoS), enables rapid development of amorphous microprecipitated bulk powder (MBP) formulations for poorly soluble drugs. This method optimizes polymer selection, drug loading, and solvent ratios for enhanced drug delivery.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Poorly soluble compounds pose formulation challenges for traditional manufacturing methods like spray drying and melt extrusion.
  • Amorphous solid dispersions are crucial for improving the bioavailability of such compounds.
  • Microprecipitated bulk powder (MBP) offers a novel approach to creating amorphous formulations.

Purpose of the Study:

  • To develop and validate an efficient high-throughput screening method for microprecipitated bulk powder (MBP) formulation development.
  • To identify optimal formulation parameters including polymer type, drug loading, and solvent/antisolvent ratios.
  • To demonstrate the utility of the method for both early and late-stage pharmaceutical development.

Main Methods:

  • Development of miniaturized coprecipitation screening (MiCoS) using a 96-well platform.
  • Integration of drug-polymer mixing, controlled precipitation, filtration, drying, and high-throughput characterization.
  • Application of MiCoS to a model compound, glybenclamide, to determine optimal formulation parameters.

Main Results:

  • The MiCoS method successfully generated amorphous microprecipitated bulk powder (MBP) formulations.
  • Optimal conditions for glybenclamide MBP included hydroxypropylmethylcellulose acetate succinate, ≤40% drug loading, and an antisolvent (0.01 N HCl) to solvent (dimethylacetamide) ratio of ≥5:1.
  • The selected formulations demonstrated favorable solid-state stability and kinetic solubility.

Conclusions:

  • Miniaturized coprecipitation screening (MiCoS) is an effective high-throughput tool for developing amorphous microprecipitated bulk powder (MBP) formulations.
  • This method facilitates rapid selection of optimal formulation parameters for poorly soluble drugs.
  • MiCoS supports early-stage research (efficacy, PK, toxicology) and late-stage development (formulation optimization).