Abstract
To modify the release rate of piretanide, a potent loop diuretic, a double-layer tablet was designed, and in vitro release was evaluated.For a rapidly releasing portion, hydrophilic β-cyclodextrin derivatives were employed to form a water-soluble complex with piretanide. For a sustained-release portion, cellulose derivatives were used to provide appropriate hydrophobicity.The release rate of piretanide in the pH range 1.2–6.8 was automatically monitored by a pH-changeable dissolution testing apparatus. The low solubility of piretanide in acidic medium was significantly improved by complexations with dimethyl-β-cyclodextrin (DM-β-CyD) and hydroxypropyl-β-cyclodextrin (HP-β-CyD).The pH-independent slow release was attained by use of hydroxypropylcellulose (HPC):ethylcellulose (EC) matrices.Then, an optimal formulation of a double-layer tablet was obtained by the combination of each fraction.For example, the tablet consisting of the [DM-β-CyD/(HPC:EC)] system in the weight ratio [1/3(1:3)] provided a sufficiently slow release of the drug over a period of 8 h in a wide pH region following an initial rapid dissolution.
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