エチルセルロース結合剤を用いたタルク積層法によるイブプロフェンの溶出制御技術(第2報)スケールアップの影響

概要

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In this study we examined the influence of scale-up of the controlled-release dosage form of ibuprofen (IB), which was layered by talc using an ethylcellulose (EC) binder. We found that the rate of release of IB was markedly delayed by the scale-up. The mean pore size of the talc layer prepared by an experimental centrifugal fluidizing granulator was 0.6 μm, while that prepared by an industrial centrifugal fluidizing granulator was 0.16 μm. The mean pore size of the talc layer was not influenced by the amount of the layered talc. It was previously reported that the identification of granules could be expressed by the efficiency of frictional wear. We, therefore, examined a correlation between the rate of release of IB and the efficiency of frictional wear. A good correlation was found between them. These findings suggested that the amount of the layered talc and the efficiency of frictional wear determined the rate of release of IB.
1998-07-01