Solid Self Micro-Emulsifying Drug Delivery System of Dipyridamole: Preparation, Evaluation,and Pharmacokinetic Investigation

Abstract

Self-microemulsifying drug delivery system (SMEDDS) attracted massive attention of researcherstomodify solubility and bioavailability of drugs having low aqueous solubility.Dipyridamole is BCS class II drug which suffers from poor solubility and bioavailability. The objective of present work was preparation, evaluation, and pharmacokinetic study of solid SMEDDS of dipyridamole. Solid SMEDDS was prepared by solid carrier adsorption method using Aerosil 200 as carrier. The resulting solid SMEDDS was characterized by differential scanning calorimetry (DSC), Powder X-ray diffraction (PXRD), and scanning electron microscopy (SEM). Moreover, the formulation was evaluated for % drug release and in vivo pharmacokinetic conducted in male albino rats. The formation of solid SMEDDS validated by DSC and PXRD analysis. SEM showed spherical particles with altered morphology of solid SMEDDS. Dissolution of prepared solid SMEDDS was significantly greater after comparison with pure drug and marketed formulation by one-way ANOVA (p=0.00371).  Besides, solid SMEDDS formulation displayed improved pharmacokinetic parameters such as AUC and Cmax than pure drug suspension. Approximately 2 folds and 2.5 folds improvement in the Cmax and AUC0-24hrs was observed with solid SMEDDS formulation compared to drug suspension. The developed formulation was stable as estimated parameters were not changed significantly during the period of stability study.