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

Pharmaceutical solids: a strategic approach to regulatory considerations

S Byrn  1 , R Pfeiffer, M Ganey, C Hoiberg, G Poochikian
Affiliations
Review

Pharmaceutical solids: a strategic approach to regulatory considerations

S Byrn et al. Pharm Res. 1995 Jul.

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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