[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 gamma-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.