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Research Article Open access CC BY 4.0

The Design and Optimization of Fast-dissolving Oral Drug Delivery System (ODDS) of Valproic Acid (VLA) an Anti-epileptic Category Drug

Devanand Jha, Gagan Kumar Utwaliya, Kumari Sindhu, Shruti Kumari, Rajnish Jha, Rashmi Vais, Puja Kumari, Ravi Shankar Kumar, Archana Yadav, Rahul Kumar, Prachi Pandey, Rahul Pal, Mayank Kumar Tiwari, Vinay Kumar Rao Khadam

Advances in Research · pp. 152–166 · Published 28 Feb 2024

10.9734/air/2024/v25i21042

Abstract

Objective: Develop and optimize a fast-dissolving oral drug delivery system (ODDS) for Valproic acid (VLA), an anti-epileptic drug, using Design of Experiments (DoE). Methodology: DoE, a powerful tool for optimizing formulations, was employed to investigate the impact of various factors on the dissolution rate of VLA ODDS. Key factors studied included superdisintegrants (sodium starch glycolate, crospovidone), diluents (lactose, microcrystalline cellulose), and lubricants (magnesium stearate). A Box-Behnken design was used to create experimental runs, and the dissolution rate at 30 minutes was chosen as the response variable. Results: The DoE analysis revealed significant interactions between factors affecting the dissolution rate. The formulation containing sodium starch glycolate, lactose, and low magnesium stearate concentration exhibited the fastest dissolution rate (Q30 > 85% in 10 minutes). Conclusion: This study successfully designed and optimized a fast-dissolving ODDS for VLA using DoE. The optimized formulation offered rapid drug release, potentially improving patient compliance and therapeutic efficacy. This approach demonstrates the effectiveness of DoE in optimizing pharmaceutical formulations for enhanced performance. The findings indicated that the RSM was effectively utilized in developing valproic acid fast dispersible tablets, thus representing a significant progress in the treatment of epileptic seizures.

Design of experiments optimization epileptic response surface methodology development disintegration computational approach formulations dissolving tablet

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