M. Tobio et Mj. Alonso, Study of the inactivation process of the tetanus toxoid in contact with poly(lactic glycolic acid) degrading microspheres, STP PHARM S, 8(5), 1998, pp. 303-310
This paper investigates the major causes of inactivation of tetanus toroid
in the presence of poly:(lactic/glycolic acid) degrading microspheres, and
shows strategies for overcoming this inactivation process. The stability of
the tetanus toroid in contact with poly(lactic/glycolic acid)polymers was
evaluated by incubating the vaccine in a suspension of blank microspheres m
ade of various types of poly(lactic/glycolic acid) copolymers at 37 degrees
C. Results indicated that the inactivation of the toxoid was due in part t
o its interaction with poly (lactic/glycolic acid) and its degradation prod
ucts. It was also found that the toroid precipitated because of the decreas
e in the pH as a consequence of polymer degradation. The extent of the inac
tivation process was dependent opt both the molecular weight and hydrophili
city of the polymer. Finally, the evaluation of the effect of several stabi
lizing agents which were incorporated into the incubation medium demonstrat
ed their ability to block the interaction between tetanus toxoid and poly(l
actic/glycolic acid) polymers. Among the stabilizing agents, gelatin A show
ed excellent properties to stabilize tetanus vaccine.