[Preparation, release and immunogenicity evaluation of HBsAg-PLGA microspheres].
OBJECTIVE
To investigate microencapsulation technique, release of HBsAg-PLGA microspheres and degradation of the polymer in vitro, and the level of immune response after the single-dose HBsAg-PLGA microspheres subcutaneously injected (sc) to BALB/c mice.


METHODS
HBsAg-PLGA microspheres were prepared by double emulsion microencapsulation technique with orthogonal experiments. The pharmaceutical characteristics of size and surface morphology, antigen loading efficiency, release of HBsAg-PLGA microspheres and degradation of the polymer in vitro, and the level of immune response after single sc of PLGA microspheres in BALB/c mice were investigated.


RESULTS
The concentration of PVA was the significant factor affecting the particle size (P<0.05). The release of protein from the microspheres was controlled mainly by the bulk erosion of polymer matrix. When single sc of HBsAg-PLGA microspheres mixed with different formulations, the immunogenicity effect was comparable to that of the aluminium adjuvant vaccine.


CONCLUSIONS
The single-dose HBsAg-PLGA microspheres mixture with different release behavior is a promising candidate for controlled delivery vaccine.
Feng
Li
L
Department of Pharmaceutics, Peking University School of Pharmaceutical Sciences, Beijing 100083, China.
Zhou
Xing-jun
XJ
Qi
Xian-rong
XR
D000818:Animals; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000737:chemistry / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000737:chemistry / Q000276:immunology* / Q000493:pharmacokinetics; D007114:Immunization / Q000379:methods; D007279:Injections, Subcutaneous; D019344:Lactic Acid / Q000737:chemistry*; D051379:Mice; D008807:Mice, Inbred BALB C; D008863:Microspheres; D010316:Particle Size; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer
D003692:Delayed-Action Preparations; D004337:Drug Carriers; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid