Exploratory Data Analysis Methods for Comparison of Drug Dissolution Profiles

摘要

A new approach for "similarity" testing through comparison of drug products dissolution profiles, based on multivariate data analysis is presented. The dissolution curves corresponding to three products containing oxicams (piroxicam, meloxicam and tenoxicam) as oral solid dosage forms were obtained by dissolution tests at multiple pre-specified time points and in different compendial media. Dissolution data was simultaneously subjected to principal component and cluster analysis and comparisons between the dissolution characteristics of different products were carried out. All the results were compared with information provided by the difference (f1) and similarity (f2) factor tests. Unlike the/2 criterion, the proposed methods reflect variability within the individual dissolution curves, being also highly sensitive to profile variations.