PHARMACEUTICAL SOLIDS - A STRATEGIC APPROACH TO REGULATORY CONSIDERATIONS

This review describes a conceptual approach to the characterization of pharmaceutical solids. Methods. Four flow charts are presented: (1) p olymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous fo rms. Results. These flow charts (decision trees) are suggested as tool s to develop information on pharmaceutical solids for both scientific and regulatory purposes. Conclusions. It is hoped that this review wil l lead to a more direct approach to the characterization of pharmaceut ical solids and ultimately to faster approval of regulatory documents containing information on pharmaceutical solids.