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.
Subject(s)
Chemistry, Pharmaceutical/methods , Drug and Narcotic Control , Pharmaceutical Preparations/chemistry , Chemical Phenomena , Chemistry, Physical , Decision TreesABSTRACT
In the May 23, 1985 issue of the New England Journal of Medicine, Dr. Sedman et al. reported that many drug products that are routinely administered in parenteral therapy contain aluminum. From a manufacturing and control perspective, the Agency had obtained considerable information and data regarding (1) sources of aluminum contamination, (2) types of parenteral drug products containing aluminum, and (3) assay methodologies. Currently, in the review of drug applications in DSDDP, applicants are being requested to incorporate aluminum monitoring into their stability protocols and to implement, where possible, changes that will reduce aluminum contamination. Since acceptable analytical procedures are available and the aluminum contaminate is believed to be harmful to certain patient populations receiving parenteral therapy, the Agency is considering actions resulting in the imposition of regulatory controls.
