DEVELOPMENT AND IN-VITRO ASSESSMENT OF DIVALPROEX SODIUM BILAYERED TABLETS

Formulation and Evaluation of Bilayer Tablets for Divalproex sodium

  • Dr. Raghavendra Kumar Gunda Narasaraopeta Institute of Pharmaceutical Sciences
  • Dr Tirumala Devi Kolli
DOI https://doi.org/10.31069/japsr.v7i2.08

Abstract

Objective: The aim of the current research work is to develop a bi-layered Divalproex sodium tablet with an immediate release layer and a sustained release layer. Divalproex sodium is regarded as the most significant antiepileptic medication and is frequently used to treat bipolar illness, epilepsy, and migraine prevention.


Methods: Wet granulation was used to prepare both (Immediate release, Sustained release) layers since Divalproex had poor flow properties. Superdisintegrants were used to produce the immediate release layer, which was then assessed for physical characteristics, disintegration time, and in-vitro drug release.


Results: For the bi-layered tablet formulation, the optimal immediate release layer (IF6) with the maximum in-vitro release of 98.11 was chosen. Along with in vitro drug release tests, HPMC-K4M and HPMCK100M polymers were utilized in varying amounts and combinations to delay the release of the drug from the sustained release layer. The polymers were also assessed for physical parameters. The Divalproex sodium release is prolonged for more than eighteen hours by the optimized sustained release layer (SF8). Ultimately, Divalproex sodium's chosen sustained release layer and immediate release layer were twice compressed to create bi-layered tablets. The tablets were assessed for their in-vitro drug release, consistent drug content, friability, thickness, hardness, and weight variation. Every physical parameter fell within the pharmacopeial specification's permitted range.


Conclusion: The best formulation (SF8) contained 26.25 mg of HPMC-K4M and 26.25 mg of HPMC-K100M  showed promising results for obtain desired drug release (>90%) after 18 h and may produce patient compliance by means of reducing dosing frequency and provide chronotherapy for effective management of Epilepsy.

Keywords: Divalproex Sodium, Superdisintegrants, HPMCK-4M, HPMCK-100M, Immediate Release Layer, Sustained Release Layer

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How to Cite
Gunda, D. R., and D. Kolli. “DEVELOPMENT AND IN-VITRO ASSESSMENT OF DIVALPROEX SODIUM BILAYERED TABLETS”. Journal of Applied Pharmaceutical Sciences and Research, Vol. 7, no. 2, Aug. 2024, pp. 46-52, doi:10.31069/japsr.v7i2.08.
Issue
Vol 7 No 2 (2024): Volume 7, Issue 2, 2024
Section
Research Articles

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