Factorial Design And Optimization Of Antiepileptic Drug: Lamotrigine Cocrystals Immediate Release Tablets

Abstract

Objectives: The current study goal was to come up with an immediate release (IR) formulation for lamotrigine. Lamotrigine is a low soluble and high permeable biopharmaceutical classification class (BCS)-II drug. Method: 4-Hydroxy benzoic acid (4HBA), saccharin sodium (SAC), and methyl paraben (MP) were used as cocrystals formers to form IR tablets of lamotrigine. Variable amounts of L-Hydroxypropyl cellulose (L-HPC) and Croscarmellose sodium in different quantities using factorial design (22) by wet granulation. The amounts of the superdisintegrant (L-HPC and Croscarmellose sodium) X1 and X2 were chosen as independent variables to acquire drug release, respectively. The dependent variables were drug release, hardness, and disintegration time. Results: For each cocrystals formation, four formulations were created (4-HBA, SAC, MP), and a total of 12 formulations were tested utilizing pharmacopoeia limits. All of the factorial batches were found to be within the standard limits. All formulation dissolution characteristics were kinetically fitted, and numerous statistical parameters were established. For the dependent variables, polynomial equations were created and verified. Formulation F11, which contained 10 mg of HPC SSL and 3 mg of Croscarmellose sodium, was the most comparable (similarity factor (f2) =60.86, difference factor (f1) =8.36) to the commercial product (Lamictal). Conclusion: Fickian diffusion, and zero-order kinetics (n = 0.3479) are followed by the optimal formulation (F11). The F11 formulation is used to treat simple and complicated partial seizures as well as generalized tonic-clonic seizures that are resistant to multiple medication treatments. The best formulation shows good retention characteristics, which will ultimately improve the clinical response.