Abstract

FORMULATION AND EVALUATION OF BI-LAYERED TABLET OF DIVALPROEX SODIUM

*Neha Yadav, Dr. Navjot Singh and Dr. Anwar IQBAL Khan

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Abstract

The aim of present work is a formulation and evaluation of bi-layer tablet of Divalproex sodium, which is used in treatment of epilepsy, bipolar disorders and used in prophylaxis of migraine, was carried out. The formulation known as bi-layered tablet was developed with the aim to deliver the Divalproex sodium as immediate release and extent the drug release for 18 hours for the better and extended clinical effect. Compatibility studies by FTIR indicate that no significant interactions between excipients. Both layer were prepared by wet granulation and punched separately. Six formulations (IF1-IF6) of immediate release tablets were prepared by using sodium starch glycolate and croscarmellose sodium. Eight formulations (SF1-SF8) of sustained release were prepared by using HPMC K4M and HPMC K100M in different ration and combination. All formulations were evaluated for precompression and post-compression parameters. Bi-layered tablets were prepared by using selected best formulations of each layer. IF6 from immediate release layer as they showed 98.62 % drug release within 20 minutes. SF8 from sustained release layer as they showed 94.29 % drug release at 18 hours and also the release pattern was within the limit of sustained release tablet. Prepared bi-layered tablet were evaluated for post-compression paramaters. Drug excipient interaction was determined by FTIR. Short term stability studies of formulated bi-layered tablet were carried out at 400C / 75% RH for 3 months. Stability studies at 40 0C / 75 % RH for 3 months for bi-layered tablet batches indicated that there are no significant loss in drug content, release profile and physical appearance.

Keywords: Sustained release, dosing frequency, Evaluation, drug content, bioavailability.