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Pharmaceutical Solids: A Strategic Approach to Regulatory Considerations

Abstract

Purpose. This review describes a conceptual approach to the characterization of pharmaceutical solids.

Methods. Four flow charts are presented: (1) polymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous forms.

Results. These flow charts (decision trees) are suggested as tools to develop information on pharmaceutical solids for both scientific and regulatory purposes.

Conclusions. It is hoped that this review will lead to a more direct approach to the characterization of pharmaceutical solids and ultimately to faster approval of regulatory documents containing information on pharmaceutical solids.

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Byrn, S., Pfeiffer, R., Ganey, M. et al. Pharmaceutical Solids: A Strategic Approach to Regulatory Considerations. Pharm Res 12, 945–954 (1995). https://doi.org/10.1023/A:1016241927429

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  • DOI: https://doi.org/10.1023/A:1016241927429

  • polymorph
  • hydrate
  • amorphous form
  • desolvated solvate