When dissolution profiles or a similar term is used in this guidance, data should be generated in a comparative manner as follows:
At least 12 dosage units (e.g. tablets, capsules) of each batch must be tested individually, and mean and individual results reported.
The percentage of nominal content released are measured at a minimum of three (3) suitably spaced time points (excluding zero time point) to provide a profile for each batch (e.g. at 5, 15, 30 and 45 minutes, or as appropriate to achieve virtually complete dissolution).
The batches are tested using the same apparatus and, if possible, on the same day.
The stirrer used is normally a paddle at 50 rpm for tablets and a basket at 100 rpm for capsules. However, other systems or speeds may be used if adequately justified and validated.
Test conditions are those used in routine quality control or, if dissolution is not part of routine quality control, any reasonable, validated method.
The similarity factor, f2, is calculated using the equation and conditions stated in Appendix I of the European Medicines Agency (EMA) Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev 1/Corr**) to demonstrate the similarity of two dissolution profiles. The f2 value must be between 50 and 100.
If more than 85 per cent of the active substance is dissolved within 15 minutes in all tested batches, dissolution profiles are considered to be similar without the need to calculate the similarity factor.
If there are insufficient quantities of recently manufactured batches available to meet this requirement, then both:
test retention batches
explain in the test report why this was done, stating the age and storage history of the samples.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.