PHARMACOKINETICS AND ENHANCED ORAL BIOAVAILABILITY IN ALBINO RABBITS OF SIMVASTATIN NANOPARTICLES
Anilkumar J. Shinde*, Harinath N. More
ABSTRACT
Aims: The aim of the study was to compare the single dose oral bioavailability of simvastatin nanoparticles (SV), Simvastatin pure drug and marketed tablet formulation in albino rabbits. Study design: Plasma was analyzed for simvastatin using a sensitive, reproducible, accurate and validated RP-HPLC method. Pharmacokinetic parameters including AUC, Cmax, Tmax, t1/2, MRT and Kel were determined from plasma concentration of the simvastatin nanoparticles, simvastatin pure drug and marketed tablet formulations. Methodology: Albino rabbits were grouped as standard I (6), Standard II (6) and Test (6). Simvastatin pure drug and simvastatin marketed formulation were administered to standard group. Simvastatin loaded nanoaprticles suspension was administered to test group. The pharmacokinetic parameters of SV nanoparticles, SV pure and SV marketed tablets were compared in albino rabbits. Results: Cmax of SV nanoparticles was found to be 63.35±0.195 ng/ml, whereas Cmax value for the drug suspension and marketed tablet formulation was found to be 34.00 ± 0.100 ng/ml and 46.91± 0.194 ng/ml respectively (p < 0.001). AUC (0–8h) value for the simvastatin nanoparticles, drug suspension and marketed tablet formulation were found to be 235.36 ± 0.101 (ng/ml×h), 152.72±0.20 (ng/ml×h) and 189.22± 0.23 (ng/ml×h) respectively (p<0.001). The results revealed that relative bioavailability (Fr %) was increased as compared to oral control group standard I and II. Conclusion: Simvastatin nanoparticles showed a significant improvement in bioavailability as compared with the pure drug and conventional marketed tablet.
Keywords: Bioavailability, Pharmacokinetics, RPHPLC, Simvastatin, Nanoparticles.
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