Development and Evaluation of Floating Drug Delivery System of Tetrabenazine by Using QbD Principles

Abstract

Conventional immediate release dosage forms do not control the drug release which leads to low newlineoral bioavailability and more toxic effects. This happens due to multiple dosing and fluctuations newlinein the plasma drug concentrations. Retention of the dosage forms in a specific region of the GIT newlineprovides more benefits, for those drugs which have poor absorption in stomach, low solubility newlineand degradation in alkaline pH. FDDS is one among the important system with gastric retention newlineproperties. Formulations designed as FDDS, controls the rate of drug release by prolonging the newlinegastric retention for extended hours and improves the absorption as well as bioavailability. This newlinearticle provides information on recent trends of research and development in FDDS with a newlinespecial emphasis on its importance for oral controlled drug delivery system. This review article newlinealso provides information on category of drugs and different polymers used for FDDS. newlineThe present studies discuss about the quality by design (QbD)-based development and evaluation newlineof chronomodulated release drug delivery system of Tetrabenzine for management of Chorea. newlineInitially, target product profile was defined and critical quality attributes were earmarked. Risk newlineassessment study was performed for identifying the critical material attributes. Oral route has newlinebeen commonly adopted and the most convenient route for drug administration. It has been newlinereceived more attention in the pharmaceutical field because of the more flexibility in the newlinedesigning of dosage form than drug delivery design for other routes. Gastroretensive systems can newlineremain in the gastric region for several hours and hence significantly prolong the gastric newlineresidence time of drugs. Floating drug delivery systems (FDDS) have a bulk density less than newlinegastric fluids and so remain buoyant in the stomach without affecting the gastric emptying rate newlinefor a prolonged period of time. While the system is floating on the gastric contents, the drug is newlinereleased slowly at the desired rate from the system. After the release