Development of oral immediate release and Sustained release dosage form of Simvastatin and its Pharmacokinetic evaluation

摘要

To examine newly developed single-unit of oral sustained release dosage form Simvastatin (SS) have been prepared by the wet granulation method. The hydrophilic matrix was prepared with xanthan gum with additives MCC PH101. On the in vitro drug release was studied. The studies indicated that the drug release can be modulated by varying the concentration of the polymer and fillers. Various pharmacokinetic parameters including AUC0¨Ct, AUC0¨C?T, Cmax, Tmax, T1/2, and elimination rate constant (Kel) were determined from plasma concentration of both formulations of test (Simvastatin 0.7 mg tablets) and reference (Simvastatin 1.4 mg tablets). The extent of absorption of drug from the sustained release tablets was significantly higher than that for the marketed simvastatin tablet because of lower elimination and longer half-life. Various pharmacokinetic parameters including AUC0-t, AUC0-?T, Cmax, Tmax, T1/2, and Keliwere determined from plasma concentratio n of both Sustained and Immediate release tablets