PURPOSE: To obtain a stable immunogen composition for oral administration by making a dried sphere comprising an immunogen capable of immunizing human body or animal and a specific gelatin enteric.
CONSTITUTION: A composition which comprises a dried sphere comprising an immunogen (e.g. immunogen for influenza, Japanese B encephalitis, hepatitis B, pertussis or non-A, non-B type hepatitis) capable of immunizing human body or animal and a gelatin having 80,000-120,000 average-molecular weight and ≥150 (bloom, g.6.2/3%) jelly strength and is made enteric by coating with an enteric coat and enteric capsulation. The amount of the immunogen used is preferably 1/50-1/108 (weight ratio) to gelatin. Gelatin is uniformly mixed with a buffering sodium chloride injection containing an immunogen at low temperature and heated to give a gel, which is poured into a liquid which is non- compatible with water and is physiologically atoxic to form soft spheres. The soft spheres are dried at low temperature to give solid spheres, which are made enteric to give the objective immunogen composition.
SEKI KUNIHARU (JP)
OHYAMA KATSUHIKO (JP)