Volume 4, Issue 9
Formulation development, evaluation and accelerated stability studies of entecavir tablet dosage form
Nawazish Alam, Monika Sharma, Sarfaraz Ahmad, Md. Sajid Ali, Md. Sarfaraz Alam, Md. Intakhab Alam
Abstract: In present investigation an attempt has been made to design and develop compressed tablet dosage form of entecavir drug. Optimization studies were done for the selection of glidant, lubricant and coating materials. Evaluation of granules was done on the basis of preformulation studies. Pre compression and post compression parameters were evaluated for optimization. The prepared tablets were evaluated for physicochemical properties. The in- vitro release studies were performed as per USP and compared with marketed product. The release of entecavir were analysed by high performance liquid chromatography (HPLC). Comparative dissolution studies and assays between optimized formulation and reference product showed better release and equivalent drug content. Stabilities studies were performed in both blister as well as cold form blister packings. Stabilities studies revealed the suitability of blister package in comparison to the cold form blister packing. The drug used in this formulation is used for the treatment of Hepatitis-B. Lactose monohydrate is used as diluent in tablet formulation which is safe to diabetic patients.
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