PREPARATION AND EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM CONTAINING TERBUTALINE SULPHATE

Abstract

In this study, investigation of an oral colon specific, pulsatile device to achieve time and/or site specific release of terbutaline sulphate, based on chronopharmaceutical consideration. The basic design consists of an insoluble hard gelatin capsule body, filled with ethyl cellulose microcapsules of terbutaline sulphate and sealed with a hydro gel plug. The entire device was enteric coated, so that the variability in gastric emptying time can be overcome and a colon-specific release can be achieved. The terbutaline sulphate microcapsules were prepared in three batches, with Ethyl cellulose and dichloromethane (1:2) by varying drug to polymer ratio and evaluated for drug content and in vitro release profile and from the obtained results; one better formulation was selected for further fabrication of pulsatile capsule. Different hydrogel polymers were used as plugs, to maintain a suitable lag period and it was found that the drug release was controlled by the proportion of polymers used. Programmable pulsatile, colon-specific release has been achieved from a capsule device over a 2–24 h period, consistent with the demands of chronotherapeutic drug delivery.