In vitro biopharmaceutical equivalence of drugs used in the treatment of tuberculosis in Peru

Context: Medicines are vital for public health, and it is essential to ensure their quality. This is especially important with multisource medications, which have not undergone clinical trials and may have limited bioavailability. Aims: To determine the in vitro biopharmaceutical equivalence of drugs used in the treatment of tuberculosis in Peru. Methods: The study evaluated multiple products for rifampicin, isoniazid, and pyrazinamide. Different dissolution conditions and sampling times were used. Similarity was determined following WHO guidelines. Results: The in vitro biopharmaceutical characteristics (dissolution profiles) of the two multisource rifampicin products were different, with similarity factors (f2) less than 50 in all three dissolution media. For isoniazid, the profiles were similar, with more than 85% dissolution at 15 minutes in all media. For pyrazinamide, two profiles were similar, and one was different, showing less than 85% dissolution in all three media. Conclusions: Multisource rifampicin products did not prove to be in vitro biopharmaceutical equivalence to each other, while isoniazid products were. Furthermore, in the case of pyrazinamide, two products were found to be equivalent, while one was not.