Abstract
The aim of the current investigation was to develop a Sustained release tablet of Donepezil Hydrochloride using non- gelling polymer in order to overcome the problem of dose dumping. Viscarin GP-209 was used as a non-gelling release modifying agent. The formulated granule blends were evaluated for powder properties. Prepared tablets were subjected to post compression evaluations. In-vitro dissolution studies were carried out in 3 different dissolution profiles. Profile1: 0.1 N Hcl medium, Profile 2: pH 5.5 sodium phosphate buffer medium and Profile3: in 0.1 N Hcl for 2hrs and in 6.8 pH sodium phosphate buffer medium using the USP Type 2 apparatus as per the FDA guidelines. The dissolution data was fitted into various kinetic models to determine the release mechanism and mean dissolution time. Formulation F6 was considered as optimized as it showed similar drug release pattern with that of innovator immediate release formulation and similarity factor (f2) of 82. F6 formulation was found to be stable up to 3 months of stability testing at 40 o c / 75%RH.
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