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AAPS PharmSciTech

, 20:176 | Cite as

Predictive and Accelerated Formulation Design Using Synchrotron Methods

  • Stephen R. ByrnEmail author
  • Xiaoming Sean Chen
  • Pamela A. Smith
Review Article Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model
Part of the following topical collections:
  1. Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model

Abstract

Predictive formulation design and accelerated formulation design can lead to the discovery of useful formulations to support drug clinical studies and successful drug approval. Predictive formulation design can also lead to discovery of a path for commercialization, especially for poorly soluble drugs, when the target product profile is well defined and a “learning before doing” approach is implemented. One of the key components of predictive/accelerated formulation design is to understand and leverage the material properties of drug substance including solubility, BCS classification, polymorphs, salt formation, amorphous form, amorphous complex, and stability. In addition, utilizing synchrotron-based PDF (pair distribution function) analysis can provide important structural information for the formulation. This knowledge allows control of physical and chemical stability of the designed product. Finally, formulation design should link to process development following Quality by Design principles, and solid-state chemistry should play a critical role in many of the steps required to achieve Quality by Design, which can lead to successful product development.

KEY WORDS

formulation quality synchrotron x-ray accelerated 

Notes

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Copyright information

© American Association of Pharmaceutical Scientists 2019

Authors and Affiliations

  • Stephen R. Byrn
    • 1
    Email author
  • Xiaoming Sean Chen
    • 2
  • Pamela A. Smith
    • 1
  1. 1.Improved PharmaPurdue UniversityWest LafayetteUSA
  2. 2.Purdue UniversityNew JerseyUSA

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