DEVELOPMENT OF A DISSOLUTION METHOD FOR ANALYSIS OF A PULSYS-TM "ANTIBIOTIC A" PRODUCT CONTAINING 4 PULSES

Abstract

Advancis Pharmaceutical Corporation TM was founded to investigate more effective and convenient ways of dosing antibiotics. Advancis TM has developed a patented drug-delivery technology called "Pulsys TM" that capitalizes on the in vitro evidence that antibiotics delivered in small "pulses" increase the effectiveness of some drugs while providing the patient with a more convenient regimen of once-daily ingestion. In order to accurately predict the performance of modified-release dosage forms, conditions utilized during an in vitro dissolution test should be representative of physiological conditions. The prototype formulations for "Antibiotic A" are designed to release at different points in the gastrointestinal tract (GI tract), resulting in a modified release profile, and should be characterized by such a dissolution method. This thesis outlines the development of a dissolution method to simulate the in vivo disintegration and release of each individual pulse to better predict the performance of the dosage form in humans.