Qbd-Based Formulation Development And Evaluation Of Floating Tablet Of Tetrabenazine Drug

Abstract

The present studies discuss about the quality by design (QbD)-based development and evaluation of chronomodulated release drug delivery system of Tetrabenzine for management of bacterial infection. Initially, target product profile was defined and critical quality attributes were earmarked. Risk assessment study was performed for identifying the critical material attributes. Oral route has been commonly adopted and the most convenient route for drug administration. It has been received more attention in the pharmaceutical field because of the more flexibility in the designing of dosage form than drug delivery design for other routes. Gastroretensive systems can remain in the gastric region for several hours and hence significantly prolong the gastric residence time of drugs. Floating drug delivery systems (FDDS) have a bulk density less than gastric fluids and so remain buoyant in the stomach without affecting the gastric emptying rate for a prolonged period of time. While the system is floating on the gastric contents, the drug is released slowly at the desired rate from the system. After the release of a drug, the residual system is emptied from the stomach. The floating bioadhesive tablet was a promising approach. The addition of gel-forming and mucoadhesive polymer like HPMC, xanthan gum, carbopol, and polyethylene oxide and gas generating sodium bicarbonate along with citric acid was essential to achieve in-vitro buoyancy desirable drug release and excellent bioadhesive strength. The formulation retained a longer period of time floated in 0.1N HCl and provided sustained release of the drug. Hence it may increase the therapeutic efficacy of the drug by increasing the bioavailability and patient compliance.