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Title: Formulation, In-vitro Evaluation and Optimization of Directly Compressible Glibenclamide Orodispersible Tablets
???metadata.dc.contributor.*???: Prof. Tsige Gebre-Mariam
Dr. Anteneh Belete
Solomon Bayu
Keywords: Glibenclamide, Orodispersible tablets, crospovidone, Sodium bicarbonate, Direct compression, central composite design, Optimization.
Issue Date: Dec-2016
Publisher: AAU
Abstract: Glibenclamide (GLM) is an orally active hypoglycaemic agent which belongs to sulphonylurea group. It controls blood glucose level primarily acting on beta cells, which are the insulinproducing cells of pancreatic islet tissue to increase their sensitivity to glucose and to stimulate the production and release of more insulin. It is used for the treatment of noninsulin dependent diabetes mellitus (NIDDM). It shows poor absorption and low bioavailability from a conventional tablet, which is attributed to its poor water solubility. In this study crospovidone and sodium bicarbonateas disintegration agent and dissolution enhancer, respectively, were used to formulate and optimize orodispersible tablets (ODT) of GLM in order to minimize absorption lag time, hasten the onset of action, improve bioavailability and compliance. Tablets were prepared by direct compression technique at different levels of compression force and evaluated for physicochemical properties. Those formulations of tablets which showed better performance were optimized using central composite design. The optimized tablets were compared for their release propertieswith marketed products. The results showed simultaneous optimization of the dependent variables offered the most desirable representative optimum formulation, within the common optimum section, with hardness of 5.75 Kg/cm2, friability of 0.2%, wetting time of 16.5 sec, disintegration time of 9.4 sec and cumulative drug release of 98.0%in 30min at concentration of 9.73mg crospovidone, 30.33mg sodium bicarbonate and 16.3KN compression force. The validity of obtained optimal point was confirmed by the low magnitude of percent prediction errors of the response variables. Comparative study of the cumulative drug release of GLM within 60 min between marketed conventional tablet of GLM (Daonil®) and the optimized ODT with the model independent method revealed that there was a significant difference between the two formulations with a dissimilarity factor ƒ1value of 73.25% and similarity factor ƒ2value of 9.01%.Thus, the results of this study showed ODT of GLM possess significantly rapid disintegration and enhanced dissolution profiles.
Description: A thesis submitted to the School of Graduate Studies of Addis Ababa University in partial fulfilment of the requirements for the Degree of Master of Science in Pharmaceutics
Appears in Collections:Pharmacology and Clinical Pharmacy

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