분할사용으로 처방된 Nifedipine 서방형 정제의 임상적 유용성
Clinical Usability of the Controlled-Releasing Nifedipine Tablets Dispensed in Split-Form
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Nifedipine is used for relieving angina strokes or lowering high blood pressure. When it comes to urgent high blood pressure, nifedipine soft capsules are bitten or administered sublingually to lower the blood pressure rapidly. However, the production of nifedipine soft capsules has been shut down and in some cases nifedipine controlled-release tablets have been used as an alternative in quartered or powdered forms though they are not supposed to be divided or ground. This study compares the dissolution profile of quartered nifedipine controlled-released tablets with that of nifedipine soft capsules to determine the clinical significance. Each 18 sample medicines were taken from the test and control group. Half of each sample was dissolved in the artificial gastric juice (pH 1.2) and the artificial intestinal juice (pH 6.8) for 30 minutes. Five mililiters of the liquid was taken from each solution at 5, 10, 15 and 30 minutes after starting the dissolution and has been filtrated for analytic procesures. Nifedipine soft capsules shows more than 85% of mean dissolution rate in 15~30 minutes in both artificial gastric juice and artificial intestinal juice. The mean dissolution rate of quartered nifedipine controlled-release tablets do not fit within ±15% of the dissolution profiles of the control drug. It means the test drug and the control drug are not equivalent in dissolution profile. The blood pressure lowering effect of quartered nifedipine controlled-released tablets will not be as big as that of nifedipine soft capsules.
Abstract
Nifedipine is used for relieving angina strokes or lowering high blood pressure. When it comes to urgent high blood pressure, nifedipine soft capsules are bitten or administered sublingually to lower the blood pressure rapidly. However, the production of nifedipine soft capsules has been shut down and in some cases nifedipine controlled-release tablets have been used as an alternative in quartered or powdered forms though they are not supposed to be divided or ground. This study compares the dissolution profile of quartered nifedipine controlled-released tablets with that of nifedipine soft capsules to determine the clinical significance. Each 18 sample medicines were taken from the test and control group. Half of each sample was dissolved in the artificial gastric juice (pH 1.2) and the artificial intestinal juice (pH 6.8) for 30 minutes. Five mililiters of the liquid was taken from each solution at 5, 10, 15 and 30 minutes after starting the dissolution and has been filtrated for analytic procesures. Nifedipine soft capsules shows more than 85% of mean dissolution rate in 15~30 minutes in both artificial gastric juice and artificial intestinal juice. The mean dissolution rate of quartered nifedipine controlled-release tablets do not fit within ±15% of the dissolution profiles of the control drug. It means the test drug and the control drug are not equivalent in dissolution profile. The blood pressure lowering effect of quartered nifedipine controlled-released tablets will not be as big as that of nifedipine soft capsules.
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