FORMULATION AND IMMUNOGENICITY STUDY OF ENTERIC COATED NANOPARTICLES LOADING HBSAG AND KELOR LEAVES EXTRACT (MORINGA OLEIFERA LAM.)

• Main Author: Rafiasti Wulandari, Ghina
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/54359
• Institution: Institut Teknologi Bandung

Hepatitis B disease became a global health issue. The effectiveness of hepatitis B vaccine by intramuscular injection has worked well in reducing transmission of the disease. WHO encourage the development of oral Hepatitis B vaccine to simpify the transport, storage, and administration in low income countries (LIC). The development also facilitated an effective immunization program to prevent sexually transmitted Hepatitis B. In order improve immunogenicity and prevent degradation in gastrointestinal tract, we offered an alternative strategy to deliver HBsAg loaded nanoparticles by oral administration and adjuvanted by loading kelor (Moringa oleifera Lam.) extract in concentration 10, 50, and 100 µg/mL along with 10 µg/mL HBsAg into nanoparticles. Nanoparticles were prepared by ionic gelation method using chitosan polymer and sodium tripolyphosphate as cross linker. Nanoparticles were having a size of 160-240 nm and a positive zeta potential of 27-34 mV. Entrapment efficiency study showed that 86-91% HBsAg and 86-93% M. oleifera extract were entrapped in nanoparticles. Nanoparticles were coated with sodium alginate, Eudragit FS30D, Eudragit S100, and poloxamer. The particles were characterized by size, zeta potential, entrapment efficiency, and the release of HBsAg. Enteric coated nanoparticle’s in vivo imunogenicity study was conducted and immune responses are evaluated. The immune responses were determined by measuring the end point titre (EPT) of IgG that formed after day-7 and day-38 using ELISA analysis. Based on first period of in vivo study, showed that the best EPT was achieved by administration of 50 µg/mL kelor extract dan this concentration was used in second period by separated nanoparticles. Based on immune responses on second period showed that HBsAg nanoparticles and kelor extract nanoparticles coated sodium alginate and EU-FS30D which administered separately and one hour interlude showed the best EPT values. Furthermore, that formula has significant EPT value (p<0,01) compared with that of HBsAg nanoparticles. Nanoparticles loading HBsAg and M. oleifera extract were a potential formulation for oral vaccine.