Formulation and Evaluation of Orodispersible Tablets Containing Co-Crystals of Modafinil

Abstract

Background: Modafinil is a CNS stimulant used to treat Narcolepsy, sleepiness and other disorders related to sleep. It is a BCS class II drug having poor aqueous solubility.
 Objective: This study was aimed to formulate and evaluate orodispersible tablets of containing co-crystals of Modafinil for the improvisation of critical attributes of the product such as dissolution rates, solubility and oral bioavailability.
 Methods: Co-crystals were prepared by dry grinding method using Sodium acetate, Nicotinic acid, Benzoic acid, Urea and Succinic acetate as co-formers. Tablets were compressed by using direct compression method using SSG, Crospovidone, and Croscarmellose sodium as super disintegrants in different concentration.
 Results: Pre-formulation studies were performed and evaluation of prepared co-crystals revealed that Co-crystals formulated with sodium acetate showed best results. The manufactured orodispersible tablets were evaluated for different parameters including weight variation, hardness, thickness, friability, drug content, In-vitro disintegration and In-vitro dissolution studies. Formulation F2 shows significant change in dissolution rate and also helped to increase the solubility of poorly water soluble drugs and both of them i.e. solubility and percentage of drug release are the key factors to exhibit the efficiency of the drug. Formulation of co-crystal with sodium acetate in 1:1 ratio showed highest drug content (97.97%), while Benzoic acid in ratio 1:2 showed least drug content (56.48%).
 Conclusion: According to the result obtained, an orodispersible tablet containing co-crystals of modafinil enhances the dissolution rate, solubility and hence increases the therapeutic efficacy and could be considered convenient oral delivery systems to enhance the drug bioavailability.
 Keywords: Co-crystal, Oro-dispersible, Sodium acetate, Narcolepsy, Sleepiness