Drug development and industrial pharmacy vol:26 issue:4 pages:391-401
The results of the stability study of ticlopidine formulations (250 mg and 100 mg) show that products available in many countries worldwide exhibit different stability characteristics. Stability testing under the International Conference on Harmonization (ICH) accelerated test conditions (40 degrees C/75% relative humidity [RH], 3 and 6 months) was performed on a total of 43 products obtained from 18 countries. The samples were visually examined for physical change and analyzed for their content of degradation products, remaining ticlopidine, and in vitro dissolution characteristics (in the case of tablets). Only 6 (16%) of all the samples submitted to this study had a good stability profile. Their appearance remained unchanged during the study; assay results were between 95% and 100%; their impurity content did not exceed 0.25%; and in the dissolution test, at least 75% of ticlopidine was dissolved after 30 min. Three samples had excellent dissolution properties and showed a very high purity level (viz. 21, 40, and 43) over the course of the study.