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Pharmaceutical Solids: a Strategic Approach to Regulatory Considerations

Overview
Journal Pharm Res
Specialties Pharmacology
Pharmacy
Date 1995 Jul 1
PMID 7494814
Citations 49
Authors
S Byrn
R Pfeiffer
M Ganey
C Hoiberg
G Poochikian
Affiliations
Soon will be listed here.
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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