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Relative bioavailability of four controlled-release nifedipine products
R Schall1, F O Müller, H K Hundt
1FARMOVS Institute for Clinical Pharmacology and Drug Development, Department of Pharmacology, University of the Orange Free State, Bloemfontein, Republic of South Africa.
Biopharmaceutics & Drug Disposition
|August 1, 1994
Summary
Two nifedipine formulations were compared for bioavailability. Both Adalat Retard and Adalat XL (GITS) showed bioequivalence, but Adalat XL offers superior controlled-release properties for once-daily dosing.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Delivery Systems
Background:
- Nifedipine is a widely used calcium channel blocker for managing hypertension and angina.
- Controlled-release formulations aim to provide sustained drug delivery and improve patient compliance.
- Different nifedipine formulations vary in their release characteristics and dosing frequency.
Purpose of the Study:
- To compare the relative bioavailability of different controlled-release nifedipine formulations.
- To evaluate the pharmacokinetic profiles and controlled-release properties of Adalat Retard and Adalat XL (GITS).
- To determine the suitability of nifedipine GITS for once-daily administration.
Main Methods:
- Two randomized, crossover clinical studies involving healthy male volunteers.
- Study 1: Assessed relative bioavailability of two 10 mg Adalat Retard vs. one 20 mg Adalat Retard, both administered 12-hourly.
- Study 2: Assessed relative bioavailability of two 30 mg Adalat XL (GITS) vs. one 60 mg Adalat XL (GITS) once daily, and compared with Adalat Retard (20 mg + 10 mg) 12-hourly.
Main Results:
- All investigated nifedipine products demonstrated bioequivalence regarding the extent of nifedipine absorption.
- Nifedipine GITS (Adalat XL) exhibited superior controlled-release characteristics compared to Adalat Retard.
- Pharmacokinetic data confirmed the sustained release profile of Adalat XL.
Conclusions:
- The nifedipine gastro-intestinal therapeutic system (GITS) formulation (Adalat XL) is bioequivalent to Adalat Retard.
- Adalat XL possesses enhanced controlled-release properties, making it suitable for once-daily dosing.
- These findings support the use of Adalat XL for improved therapeutic management and patient convenience.