FORMULATION, CHARACTERIZATION, AND IN VITRO TOXICITY TEST OF LIPID NANOPARTICLE DOSAGE FORM FOR SIMVASTATIN DRUG DELIVERY

• Main Author: Ricardo Setiadi, Anfield
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/78390
• Institution: Institut Teknologi Bandung

Simvastatin is one of the first line therapy for hypercholesterolemia. Therapy for lowering cholesterol levels in general is still done through oral route which has many weaknesses. Drug delivery system using lipid nanoparticles (LNP) could potentially be a new innovation for therapy using statins. However, the usage of statins have some adverse effects like constipation, headache, dizziness, and nausea. Some reports tell that the usage of statins have negative effects on male sexual health and reproductive capability which includes erectile dysfunction, decrease in Sertoli cell number, and abnormal Leydig cell morphology. In this research, simvastatin was formulated in LNP drug delivery system (LNP-simvastatin). The optimal formula in this research produced LNPsimvastatin with particle size of 93,50 ± 9,90 nm, polydispersity index (PDI) of 0,35 ± 0,06, zeta potential of -43,90 ± 13,03, and entrapment efficiency of 80,02 ± 6,80%. The safety of LNPsimvastatin was tested by in vitro toxicity test. Toxicity test was done by cell viability test with the addition of 3-[4,5-dimethylthiazol-2-yl]-2,5 diphenyl tetrazolium bromide for 3 different cell lines that were TM4, Hepa1-6, and 4T1 cell line. The results of viability test shows that LNP-simvastatin with the dose of 1 ppm is toxic for TM4 and 4T1 cell line. LNP-simvastatin with the dose of 2 and 4 ppm are toxic for the three cell lines. More siginificant toxicity was found in TM4 and 4T1 cell line.