PENGEMBANGAN NANOEMULSI SPONTAN MENGANDUNG LIOFILISATINSULIN-FOSFOLIPID UNTUK RUTE ORAL: KARAKTERISASI DAN UJIAKTIVITASNYA

• Main Author: Manuel Haryadi, Bernard
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/79050
• Institution: Institut Teknologi Bandung

Purpose: Non-invasive Insulin administration is expected for better therapy for Diabetes Mellitus. In this research, it was developed formulation of insulin for oral delivery. Method(s): Insulin was formulated into nanoemulsion (NE) carrier using spontaneously nanoemulsification (SNE) process. To increase lipophilicity of insulin, insulin was dispersed in phospholipid resulted Insulin-Phospholipid Lyophilisate (IPL). The NE formula was from previous work which contained Glyceryl Monooleate (GMO), Tween 20, and Polyethylene Glycol (PEG 400) in ratio IPL characterization included PXRD, FTIR spectroscopy, and Raman spectroscopy. NE characterization consisted of droplets size, droplets size distribution, zeta potential, entrapment efficiency, pH, physical stability, and Raman Spectroscopy. In addition, NE with expected characteristic was evaluated for in vitro release, in vitro permeation, and in vivo activity. Result(s): Insulin NE has characters of: droplets size 102.17 ± 5.50 nm, droplets size distribution 0.197 ± 0.017, zeta potential 0.56 ± 0.10 mV, entrapment efficiency 90.33 ± 0.65 %, pH 6.01 ± 0.05, stable after centrifugation at 14,000 g for 30 minutes in room temperature, and similar Raman spectrum with BSA NE which was successfully formed. Insulin NE prepared to Film Liquid of Insulin Nanoemulsion (FLIN) using Carboxymethyl Chitosan (CMCs) polymer. From in vitro release and permeation results, it was known that CMCs polymer functioned as Insulin NE release controller. Both of Insulin NE and FLIN administered orally in healthy Swiss-Webster mice showed hypoglycemic effect with pharmacological availability about 14% instead of subcutaneously insulin injection. This effectiveness significantly increased by 4-folds compared to insulin solution given with the same route. Conclusion: Insulin formulated into nanoemulsion is promising for oral delivery.