FORMULATION AND IN VIVO IMMUNOGENICITY TEST OF ORAL NANOPARTICLE CONTAINING HBSAG WITH EXTRACT (PHYLLANTHUS NIRURI L.) AS ADJUVANT COATED WITH ENTERIC COATING POLYMER

• Main Author: C. A. Pangsibidang, Reynatha
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/54361
• Institution: Institut Teknologi Bandung

Vaccination is one of the most reliable methods used for eradicating fatal infectious diseases in the world, one of which is Hepatitis B. Currently, the available Hepatitis B vaccine in the market is formulation using HBsAg-alum which administered through the injection route. However, the injection vaccine has several drawbacks such as invasive and only induces systemic immune response. To overcome this shortage, many researcha have been carried out for the purpose of developing a safer, more comfortable, and more effective vaccine especially for the prevention of disease that sexually transmitted . One of them is a formulation of nanoparticle which administered via oral route. In this experiment, nanoparticles were formulated using the ionotropic gelation method using chitosan and sodium tripolyphosphate (STPP) as the cross linkers. The characterization and physicochemical properties of nanoparticles was carried out by particle size analyzer, polydispersity index, zeta potential charge, particle surface morphology, as well as the percent of antigen and adjuvant uptake. In the dosage formulation, several dosage variations of meniran extract (PN) were used, which functions as adjuvant for nanoparticle preparations. The encapsulation of nanoparticles was carried out using enteric-coating polymers of sodium alginate, Eudragit FS 30 D, and Eudragit S100 to protect the entrapped antigen from the extreme acid conditions in the digestive tract. The evaluation of nanoparticles was carried out in vitro and in vivo. Nanoparticles have the average size of 200-300 nm, are spherical in shape and positively charged. HBsAg antigen uptake was 85-95%, while the amount of PN extract entrapped was 60-73%. The effectiveness of the coating of the polymers used showed that the three polymers were able to protect the adsorbed antigen under acidic conditions and release the antigen at a pH of 7.4. Besides, the results of immunogenicity evaluation showed that nanoparticles containing HBsAg with PN extract adjuvant could increase antibody titres against HBsAg antigen. Also, the highest effect of the antibody titer given by the nanoparticle antigen preparations and PN extract nanoparticles were given separately with 1 hour of delay administration