- Total exposure to generic nearly 20 per cent lower when taken after meal
An extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics. Based on the study results from in vitro and in vivo tests, the generic extended release nifedipine product has a delayed onset of drug release compared to the originator which is especially noticeable in the fed state. When the tablet is taken after a standard high fat meal, the total exposure to the generic nifedipine is almost 20 per cent lower than with Adalat(R) XL(R).
"With drugs like nifedipine, we see a close relationship between plasma concentration and efficacy. A change in bioavailability could impact blood pressure," said principal investigator Dr. Frank Donath from SocraTec R&D, Oberursel, Germany. "Since it is widely accepted that small reductions in blood pressure can reduce long-term mortality, these findings may be relevant to physicians treating hypertensive patients."