DEVELOPMENT AND PHARMACOKINETIC STUDY OF MIOCAMYCIN SUSTAINED-RELEASE TABLET REMAINING-FLOATING IN STOMACH

A novel sustained-release tablet of miocamycin was developed based on the hydrodynamically balanced controlled drug delivery system (HBS). It was prepared to contain fast-release and sustained-release granules. The γ-scintiphotographic study after oral ingestion showed that MOM-HBS remained in human stomach for more than 7 hours, much longer than the conventional tablet (3～ 4 h). The in vitro release characteristics showed basically first- order kinetics (Kr= 0.1619 h^-1 ). The serum concentration- time course of MOM-HBS exhibited typical sustained- release characteristics.Moreover, The percentage of drug released in vitro versus the percentage of drug released in vivo of MOM-HBS indicated excellent linearity. Its relative bioavailability was increased greatly compared with MOM dry syrup produced in Japan.