¹Osmotica Argentina S.A, Buenos Aires, Argentina

Abstract

A new osmotic nifedipine tablet with a controlled release profile of 24 hours, was developed. It is composed of a core containing nifedipine, a polymeric membrane and a laser drilled orifice to allow the release of the drug. The aim of the study was to assess the bioequivalency between the osmotic nifedipine tablet and the innovator Procardia|[reg]| XL (nifedipine extended release, by Pfizer). In-vitro release comparison was done according to USP 25. The study was carried out as an open-label, randomized, two period cross-over study in 24 healthy subjects. Osmotic Nifedipine 60mg tablet and Procardia|[reg]| XL 60mg tablets (nifedipine extended release) were administered as a single-dose under fasting conditions. Nifedipine was determined in the range 1-200 ng/ml by RP-HPLC with electrochemical detection. PK-parameters and statistics were performed by WinNonlin Pro 4.0. Average bioequivalence was assessed through classical 90% confidence intervals (CI), Schuirmann`s two one-sided-t-test and Anderson-Hauck test. Results:(See Table)

No statistically significant differences between products were found. The 90% CI for geometric means of AUC and Cmax ratios were within the bioequivalence limits. The new osmotic nifedipine tablet shows pharmaceutical equivalency and bioequivalency to the innovator.