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An osmotic bioequivalent nifedipine tablet
Author(s) -
Feleder E. C.,
Befumo M.,
Ricci M. A.,
Coppari M. A.,
Faour J.
Publication year - 2004
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2003.11.051
Subject(s) - bioequivalence , nifedipine , innovator , cmax , pharmacology , pharmacokinetics , chemistry , medicine , chromatography , computer science , intellectual property , calcium , operating system
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® 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® 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. Clinical Pharmacology & Therapeutics (2004) 75 , P14–P14; doi: 10.1016/j.clpt.2003.11.051Parameter Ratio (%) 90% CI 2 one‐sided T‐test A‐H P<80.0% P>125.0%Cmax 110.6 98.8 123.8 0.0000 0.0378 0.0377 AUC0–72 102.5 87.2 120.4 0.0076 0.0228 0.0152 AUCinf 102.7 88.0 119.8 0.0056 0.0197 0.0141