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Solid Form Screenings in Pharmaceutical Development: a Perspective on Current Practices.

Yue Gui1

  • 1China Innovation Center of Roche, Building 5, 371 Lishizhen Road, Shanghai, China. yue.gui@roche.com.

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|August 3, 2023
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Summary
This summary is machine-generated.

This perspective explains solid-state science for drug development. It covers solid form screening methods, characterization, and selection strategies to improve drug product manufacturing and stability.

Keywords:
crystallizationdrug developmentpolymorphismsolid form screeningsolid form selection

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Solid form screening is critical in drug development, impacting drug product stability, dissolution, and manufacturing.
  • Understanding solid-state properties is essential for successful pharmaceutical development.
  • Bridging knowledge gaps among scientists with diverse backgrounds is vital for effective solid form development.

Purpose of the Study:

  • To provide a practical overview of solid-state science and solid form screening.
  • To guide scientists in selecting optimal solid forms for drug substances.
  • To foster better communication and collaboration in pharmaceutical development.

Main Methods:

  • Overview of solid-state science principles.
  • Discussion of solid form screening timelines, goals, and techniques.
  • Presentation of methods for solid form identification, characterization, and selection.

Main Results:

  • Solid forms significantly influence drug substance stability, dissolution, and manufacturing.
  • Effective screening strategies lead to the selection of favorable solid forms.
  • Current industry practices and future research opportunities in solid form development are summarized.

Conclusions:

  • Solid form screening is a key determinant of drug product performance and manufacturability.
  • A practical understanding of solid-state science aids in optimizing drug development.
  • Continued research in solid form science offers opportunities for pharmaceutical innovation.