DESIGN AND TESTING IN-VITRO OF A BIOADHESIVE AND FLOATING DRUG-DELIVERY SYSTEM FOR ORAL APPLICATION

A new drug delivery system for a water-soluble beta-blocker drug, sotalol HCl, was developed utilizing both the concepts of adhesiveness and of flotation, in order to obtain a unique drug delivery system which could remain in the stomach for a much longer period of time. The floating and controlled-release properties of tablets consisting of cellulosic polymers were investigated. In order to validate the technological design of the new system, two different batches were made. In both cases, the time necessary for the tablets to begin to float was less than 30 min. Moreover, 90% of the drug content was released during the first 14 h. The bioadhesive property of the tablets was determined using rabbit tissue and a modified tensiometer. The new oral controlled-release system shows, at least in vitro, good characetristics in relation to three parameters: controlled release of the drug, bioadhesiveness in the stomach and intestine of rabbits and buoyancy in an acid medium.