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Miniaturized Screening Tools for Polymer and Process Evaluation

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Amorphous Solid Dispersions

Part of the book series: Advances in Delivery Science and Technology ((ADST))

Abstract

There has been an increasing interest in studying amorphous solid dispersion (ASD) approaches in response to the increasing number of poorly soluble compounds from pharmaceutical discovery in recent years. Although ASD has demonstrated drastic bioavailability enhancement, concerns over the physical instability remain as valid. By engineering amorphous solid dispersion with an appropriate polymer, the physical stability of ASD can be improved significantly. The identification of appropriate polymer and drug loading for ASD development, however, has been based on “trial and error” and is time consuming. High-throughput miniaturized screening systems offer attractive opportunities for the development of ASD by streamlining the polymer and drug loading selection processes with low demand on material, time, and resources. The main focus of this chapter is to describe and review the current miniaturized experimental ASD screening methods, including solvent casting, solvent shift, coprecipitation, melt fusion, freeze drying, and spin coating. The criticality of understanding basic physicochemical properties of active pharmaceutical ingredient (API) in developing a successful ASD is discussed. The drug–polymer interaction in the solid state and in solution upon dissolution is also briefly tackled. Finally, a rational approach for polymer and drug loading selection based on the balance of biopharmaceutical performance and ASD stability is provided.

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Acknowledgments

The authors would like to thank Dr. Michael Brandl for his comments on this manuscript and Dr. Matthias Eckhard Lauer for the AFM pictures.

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Authors and Affiliations

  1. Formulation Development, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA

    Qingyan Hu

  2. pRED, Roche Innovation Center, F. Hoffmann-La Roche Ltd., Basel, Switzerland

    Nicole Wyttenbach

  3. Research division, Chugai Pharmaceutical Co., Ltd., Gotemba, Shizuoka, Japan

    Koji Shiraki

  4. Kashiv Pharma LLC, Bridgewater, NJ, USA

    Duk Soon Choi

Authors
  1. Qingyan Hu
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  2. Nicole Wyttenbach
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  3. Koji Shiraki
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  4. Duk Soon Choi
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Corresponding author

Correspondence to Qingyan Hu .

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Editors and Affiliations

  1. Kashiv Pharmaceuticals, Bridgewater, New Jersey, USA

    Navnit Shah

  2. Merck & Co., Inc., Summit, New Jersey, USA

    Harpreet Sandhu

  3. Kashiv Pharmaceuticals, Bridgewater, New Jersey, USA

    Duk Soon Choi

  4. Pharmaceutical Research & Early Development, Roche Innovation Center, New York, New York, USA

    Hitesh Chokshi

  5. Pharmaceutical and Analytical R&D, Hoffmann-La Roche Ltd., Nutley, New Jersey, USA

    A. Waseem Malick

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Hu, Q., Wyttenbach, N., Shiraki, K., Choi, D. (2014). Miniaturized Screening Tools for Polymer and Process Evaluation. In: Shah, N., Sandhu, H., Choi, D., Chokshi, H., Malick, A. (eds) Amorphous Solid Dispersions. Advances in Delivery Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1598-9_5

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