It has been confirmed that the combination of pH-dependent slow-release nifedipine fine granules (KB-1712P) with some types of antacids results in changes in the i
n vitro dissolution profile of nifedipine (evaluated by modified Fuchs' method). Maalox
® affected the
in vitro dissolution profile of nifedipine, while Kolantyl
® granules did not. In the present study, we conducted
in vivo study on normal healthy volunteers to confirm the effect of antacids on serum nifedipine concentration.
The antacids used in this study were Maalox
® and Kolantyl
® granules. The trial was conducted in three groups, the Maalox
®, Kolantyl
® and control groups, using the 3-way crossover method. Prior to initiation of the study, volunteers underwent medical examinations and were confirmed to be healthy and not suffering from either gastric hyperacidity or hypochlorhydria. In the control group, KB-1712P was ingested with 200ml of water, and in the antacid-treated group, one of the antacids and KB-1712P was ingested with 100 ml, respectively. The serum nifedipine concentration was then measured over time. The results showed no difference between the groups in any of the pharmacokinetic parameters of nifedipine, suggesting that the serum nifedipine concentration was little affected by the concomitant use of antacids and KB-1712P.
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