ニフェジピン持効性細粒の溶出特性と光安定性

概要

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A sustained release nifedipine fine granules, Sepamit R Granules^[○!R] (SP-RG), is a product prepared by using the technique of solid dispersion. Dissolution behavior of nifedipine from SP-RG was tested based on the results of incompatibility. The photostability of SP-RG was also tested. Dissolution rate of nifedipine from SP-RG was 12.5% in JP XII 1st disintegration test fluid (pH 1.2) and 100.9% in JP XII 2nd disintegration test fluid (pH 6.8). Dissolution of nifedipine in JP XII 2nd fluid was delayed by moisture absorption during storage (relative humidity of 75% at 20° for 30 days). Dissolution of nifedipine from SP-RG in JP XII 1st fluid was increased by mixing of SP-RG with sodium bicarbonate or heavy magnesium oxide during storage (relative humidity of 75% at 20° for 30 days). Nifedipine in SP-RG packaged with polyethylene cellophan laminate paper completely decomposed after 72 hours, under exposure to light (500 lux), while it was stable even after 30 days with aluminium polyethylene laminate paper.
日本医療薬学会の論文
1993-06-21