FORMULATION AND DEVELOPMENT OF DIVALPROEX SODIUM BI-LAYERED TABLETS USING SUPERDISINTEGRANTS AND POLYMERS

The antiepileptic medication divalproex sodium was regarded the most important and was used to treat epilepsy. Our research focused on the development of a bi-layered divalproex sodium tablet. It has two layers: an IR layer and an SR layer. The FTIR analysis demonstrated that there is no interaction between the medication and the polymer, nor between the two in combination. Both layers were made using the wet granulation approach due to the pure drug's poor flow properties. Starch, croscarmellose sodium, sodium starch glycolate, and microcrystalline cellulose were used as superdisintegrants in the IR layer, which was tested for physical characteristics, in vitro drug release, and disintegration time. The selected bilayered's optimised IR layer (IF6) with the maximum in vitro release. The sodium CMC and ethyl cellulose polymer were used in varied proportions to retard drug release from the SR layer, and the combination was assessed for physical parameters and in vitro drug release experiments. The improved SR layer (SF8) was chosen because it extends the divalproex sodium release by more than 18 hours. Finally, the SR layer and IR layer of divalproex sodium were selected from the bilayered tablets generated by double compression. Hardness, friability, thickness, drug content homogeneity, weight variation, and in vitro drug release were all tested on the tablets. All physical characteristics were within acceptable pharmacopoeia standard limits. The stability studies of shown the bilayer tablet of divalproex sodium was stable at 40oC/75% RH for 3 month of period