The objective of this program is to develop a new technology for oral delivery of drugs to the colon. The technology is based on enzyme- triggered bursting of membranes coated onto drug-containing beads. These membrane coatings contain an oil substrate for intestinal lipase. in the absence of lipase, the membranes prevent drug release, while in the presence of lipase, the membranes become permeable to water, which enters the bead and bursts the coating, releasing the drug. The combination of activation by lipase and the use of small beads should result in drug delivery that is both site-specific and time-specific - a capability that is not available with current technologies. For this Phase II program, we propose to develop a coating process to provide reproducible membrane properties, demonstrate the performance capabilities of the technology for delivering drugs with a range of properties, and determine the performance of the technology in in vivo studies in dogs. This will enable rapid commercialization of the technology for specific therapeutic applications in Phase III. The technology is expected to be useful for delivery of drugs for treatment of diseases of the colon, for systemic delivery of labile drugs, and for delivery of drugs requiring chronotherapy.
This technology would be of benefit for treatment of diseases of the colon (e.g., inflammatory bowel disease), for systemic delivery of labile drugs (e.g., peptides), for chronotherapy (e.g., hormones), for implantable drug delivery, and for sensors.
