DELAYED TOTAL RELEASE TWO PULSE GASTROINTESTINAL DRUG DELIVERY SYSTEM

摘要

a two pulse gastrointestinal deliverysystem is provided. The system comprises a desiredagent in combination with a swellable core material,the core being surrounded by an inner coat of awater--insoluble or relatively water-insoluble coatingmaterial in which particulate water-insoluble material isembedded. The inner coat is additionally surroundedby an outer coat that contains additional amounts ofthe desired agent. When the delivery device entersthe gastrointestinal tract, the outer coat releases thedesired agent contained therein and disintegrates,exposing the inner coat. The particulate matter in theinner coat takes up liquid, thus forming channelsinterconnecting the drug-containing core with theoutside of the delivery device. Through these channelsliquid enters the core which then swells to the pointat which the inner coat is broken. When the integrityof the inner coat is destroyed, the core thendisintegrates, immediately releasing all or most of the drugat a specific site. By controlling parameters in thedevice, such as the core material, carrier material inthe coating, and particulate matter, the location ofrelease of both pulses of the drug can be carefullycontrolled. The invention is also directed to a method ofusing the device for the treatment of disease by therelease of drugs in the gastrointestinal tract in alocation- and time-dependent manner.