Design and in Vitro Evaluation of Eudragit ® S100/Lipid Based Simvastatin Chronotherapeutic Drug Delivery System

Abstract

The present study was undertaken to 1) formulate a pulsatile colonic delivery of simvastatin (SIM) as chronotherapy for treatment of hypercholesterolemia, and 2) enhance the dissolution profile of the prepared SIM chronotherapeutic system. Lipid based formulations were utilized to formulate SIM in capsule dosage form coated with Eudragit® S100. SIM was formulated using different percentages of Cremophor EL40, Capmul MCM EP and PEG 400. SIM coated capsules (SIMcc) were evaluated for drug release in different pH media. The results showed that SIMcc were able to withstand the acidic pH for 2 hours. Drug release rate was higher (88%) from SIMcc containing 10% polyethylene glycol (PEG) 400. In conclusion, Eudragit® S100 as time-dependent and site specific polymer retards SIM release from coated capsules; hence SIMcc could be considered as successful pulsatile treatment of hypercholesterolemia. Also, dissolution profile of lipid based SIMcc was enhanced in comparison with that of SIM filled capsules.