International Jour nal of Recent Advances in Phar maceutical Resear ch January 2011;1:45-51 ____________________________________________________________________________________________________________________________________________ _____________________________________________________________________________________ Daisy et al, Mannosylated Bilosomes 45 Oral Immunization against Hepatitis B Virus using Mannosylated Bilosomes *DAISY ARORA (1) , BHARAT KHURANA (1) , MURUGESAN SENTHIL KUMAR (1) , SURESH P VYAS (2) (1) Nanomedicine Research Centre, Department of Pharmaceutics, Rajendra Institute of Technology and Sciences, Sirsa, Haryana, India (2) Drug Delivery Research Laboratory, Department of Pharmaceutical Sciences, Dr. H. S. Gour University, Sagar (M.P.), India Abstract Vesicular carrier systems (liposomes & niosomes) are one of the potential candidates for vaccine delivery by mucosal route. But its instability in gastrointestinal environment makes it less applicable to be used for the purpose of oral immunization. New generation bilosomes are more stable in gastrointestinal tract. In the present study, dendritic cell targeted mannosylated bilosomes were developed and characterized for their morphology, entrapment efficiency, stability in SGF and SIF. The formulation has shown significantly higher stability than plain antigen and niosomes. Immune response was also evaluated which was found to be significantly higher. Enhanced sIgA level at all local and distal mucosal sites were found as compared to bilosomes alone, while parenteral vaccine was unsuccessful to provide any considerable cell mediated response. Thus, extended humoral, cell mediated and mucosal immune responses were found using the novel non invasive vaccine which can confer protection against disease for prolonged period of time. Keywords: Hepatitis B, Oral Immunization, GALT, Bilosomes, Dendritic cell, Immunoglobulins. 1.0. I NTRODUCTI ON Hepatitis B is a type of stern and deadly viral disease caused by hepatitis B virus (HBV). It is a partially double-stranded DNA virus of the Hepadnaviridae family which includes related viruses responsible for liver injury in animals [1]. HBV is carried in blood and in other body fluids including saliva, tears, semen and vaginal secretions and can be transmitted from person to person by a variety of means. In some studies it was concluded that after its acute infection, between 1 and 10% of healthy adults and 30–90% of infected babies become chronic carriers and on later stages they are at high risk of life-threatening diseases such as cirrhosis and primary hepatocellular carcinoma (HCC). Worldwide, at least one third of the world population have been infected with HBV, over 6% of the world population are chronic carriers, ____________________________________________________________ *Correspondence Mr s. Daisy Ar or a Asst. Pr ofessor , Nanomedicine Research Center , Department of Pharmaceutics, Rajendra Institute of Technology and Sciences, Hisar Road, Sir sa, Haryana -125 055. India. Email: daisyar ora86@gmail.com -and approximately 620,000 people die each year from acute and chronic HBV infection [2]. Globally approximately 4.5 million new HBV infections occur each year, of which a quarter progresses to liver disease [ 3,4] . Immunization is the most successful measure to diminish the global prevalence of hepatitis B. Vaccination is the most important and economically attractive option for health care intervention both in terms of cost-effectiveness and benefit-cost ratios. But the present concept of vaccination is based on invasive parenteral method which is not completely effective against number of diseases [ 5] . These traditional needle-based vaccination methods suffer from various drawbacks, like the need for trained personnel to administer vaccines, patient inconvenience and the associated risk of needle-borne infections (AIDS, hepatitis, etc.) due to the use of contaminated needles [6]. The need for trained medical personnel elevated the cost of administration and confined the use of parenteral vaccines in isolated and interior areas. Further, parenterally administered vaccines mainly stimulate a systemic response and antibodies generated in this manner do not always reach to the mucosal surfaces, which is the