FORMULASI DAN EVALUASI NANOEMULSI KETOKONAZOLE

Abstract

ABSTRACT Introduction: Ketoconazole included in the Class II Biopharmaceutical Classification (BCS) classification, which means a drug that is difficult to dissolve and is highly permeable. Giving ketoconazole orally the absorption is not optimal because of solubility problems and the side effects that can cause liver damage in use for more than 1 month and patients aged over 60 years. Nanoemulsion is a dosage form that can increase the solubility and penetration of drugs, delivery for drugs that are difficult to dissolve and reduce side effects in oral administration. Objective:The purpose of this study was to determine the ketoconazole nanoemulsion formulation using high energy emulsification methods and to determine the effect of concentrations of tween 80, ethanol, and isopropyl myristate (IPM) on particle size and value of Polidispersion index (PDI) of the ketoconazole nanoemulsion. Method: Nanoemulsion formula consists of ketoconazole, tween 80, ethanol, and isopropyl myristate (IPM). Preparation of preparations was carried out by the method of high energy emulsification and subsequently an evaluation of the nanoemulsion formula which included the characterization of the preparation, physical evaluation, and stability test. Result: Concentrations of tween 80 cause the achievement of critical micelle concentration (KMK) so that the micelles (matrix) will form tightly and cause ketoconazole to be trapped inside the micelle (matrix). Conclusion: The results of the preparation of the formula obtained the best formula are the F3 formula with 80 36% tween concentration, 5% isopropyl myristate, and 9% ethanol.