The Design and Optimization of Fast-dissolving Oral Drug Delivery System (ODDS) of Valproic Acid (VLA) an Anti-epileptic Category Drug
Devanand Jha *
Department of Pharmacology Dhanarua School of Nursing and Paramedics, Bihar University of Health Science Patna, Bihar, 800001, India.
Gagan Kumar Utwaliya
Department of Pharmacology Dhanarua School of Nursing and Paramedics, Bihar University of Health Science Patna, Bihar, 800001, India.
Kumari Sindhu
Department of Pharmaceutics, Himalaya College of Pharmacy, Bihar University of Health Science Patna, Bihar, 800001, India.
Shruti Kumari
Department of Pharmaceutics, Himalaya College of Pharmacy, Bihar University of Health Science Patna, Bihar, 800001, India.
Rajnish Jha
Department of Pharmacology, MMT CSM Group of Institutions Prayagraj, Dr. A.P.J. Abdul Kalam Technical University, Lucknow, UP, 226031, India.
Rashmi Vais
Department of Pharmaceutics, J.B.B. Group of Institute Prayagraj, Dr. A.P.J. Abdul Kalam Technical University, Lucknow, UP, 226031, India.
Puja Kumari
Department of Pharmacognosy, Dhanarua School of Nursing & Paramedics, Bihar University of Health Science Patna, Bihar, 800001, India.
Ravi Shankar Kumar
Department of Pharmacognosy, Dhanarua School of Nursing & Paramedics, Bihar University of Health Science Patna, Bihar, 800001, India.
Archana Yadav
Department of Pharmacognosy, Dhanarua School of Nursing & Paramedics, Bihar University of Health Science Patna, Bihar, 800001, India.
Rahul Kumar
Department of Chemistry, Dr. K.N. Modi Institute of Pharmaceutical Education and Research, Dr. A.P.J. Abdul Kalam Technical University, Lucknow, UP, 226031, India.
Prachi Pandey
Department of Pharmaceutics, Nims Institute of Pharmacy, Nims University Rajasthan, Jaipur, 303121, India.
Rahul Pal
Department of Pharmaceutics, Nims Institute of Pharmacy, Nims University Rajasthan, Jaipur, 303121, India.
Mayank Kumar Tiwari
Department of Computer Science, Nims Institute of Computer Science & Technology, Nims University Rajasthan, Jaipur, 303121, India.
Vinay Kumar Rao Khadam
Department of Pharmaceutics, Nims Institute of Pharmacy, Nims University Rajasthan, Jaipur, 303121, India.
*Author to whom correspondence should be addressed.
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.
Keywords: Design of experiments, optimization, epileptic, response surface methodology, development, disintegration, computational approach, formulations, dissolving tablet