放出開始時間を制御した経口製剤の設計と評価
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概要
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This article reviewed the recent advance in the development of a new type of oral drug delivery system with a, timer, function, and the sigmoidal release system (SRS) is introduced as one of the most promising system for the time-controlled drug delivery, which was recently developed in our laboratory.<BR>Eudragit RS has been widely used as a controlled release barrier of pharmaceuticals. Because this polymer contains a small amount of quarternary ammonium group in its lipophylic polymer chain, the film, when prepared from aqueous suspension, exhibits a distinctive structure and can electrostatically interact with various organic acids. In fact, the hydration and hence the drug permeability of the Eudragit RS film was found to be drastically enhanced in various organic acid solutions. Thus, the SRS was designed on the basis of the physicochemical interaction between Eudragit RS film and organic acids. This technology was applied for many types of drugs, in which succinic acid was used as a release enhancer. In the dissolution study, each of SRSs provided a very unique S-shaped dissolution profile in water with an extended lag time prior to the beginning of drug release. The lag time and the release rate thereafter were both controllable by altering the amount of coating and the loading amount of succinic acid in the drug layer, respectively. The <I>in vivo</I> performance of SRS was also examined by a series of beagle dog studies, and it was found that the <I>in vivo</I> lag time was well coincident with <I>in-vitro</I> lag time in every case.
- 日本膜学会の論文