ORALLY DISPERSABLE VACCINE CONTAINING VIROSOMES Russian patent published in 2023 - IPC A61K39/12 A61P31/18 

FIELD: biotechnology.

SUBSTANCE: described solid unit dosage form for oral administration. The composition contains the following ingredients: lipid-based vesicles containing an immunogenic amount of at least one vaccine antigen; 5–20 wt.% of at least one cryolioprotectant; 25–40 wt.% of the substance forming the matrix; and 40–55 wt.% of the substance forming the structure. The following is presented: a method of inducing an immune response in a patient involving introduction of a standard dosage form into the human oral cavity. A method of obtaining a solid standard dosage form for oral administration is described. The liquid virosome composition is dosed into a preformed form. The virosome composition includes the following ingredients: lipid-based vesicles containing an immunogenic amount of at least one vaccine antigen; 1–5 wt.% of cryolioprotector; 4–8 wt.% of the substance forming the matrix; and 5–10 wt.% of the substance forming the structure. The dosed virosome composition is frozen at a temperature of -60°C to -90°C. The frozen virosome composition is annealed by keeping it at a temperature below -15°C for 3–9 hours. The hybridized virosome composition is lyophilized to form a dosage form. A method of preparing a solid unit dosage form for oral administration is also described. The liquid virosome composition is dosed into a preformed form. The virosome composition includes the following ingredients: 20–50 wt.% of virosome concentrate, where the virosome concentrate contains the following: virosomes containing an immunogenic amount of at least one vaccine antigen; 2–10 wt.% of cryolioprotector; and 60–200 mM of buffer system; 4–8 wt.% of the substance forming the matrix; and 5–10 wt.% of the substance forming the structure. The dosed virosome composition is frozen at a temperature of -60°C to -80°C. The frozen virosome composition is annealed by keeping it at a temperature below -15°C for 3–9 hours. The hybridized virosome composition is lyophilized to form a dosage form.

EFFECT: invention makes it possible to obtain virosome compositions for sublingual administration that have physical stability, integrity and stability of particles and antigens.

40 cl, 5 dwg, 17 tbl, 6 ex