Pharmaceutical solids: a strategic approach to regulatory considerations

Pharm Res. 1995 Jul;12(7):945-54. doi: 10.1023/a:1016241927429.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Chemical Phenomena
  • Chemistry, Pharmaceutical / methods*
  • Chemistry, Physical
  • Decision Trees
  • Drug and Narcotic Control*
  • Pharmaceutical Preparations / chemistry*

Substances

  • Pharmaceutical Preparations