Oral vaccine fast-dissolving dosage form using starch
View Patent ↗A fast-dissolving dosage form (FDDF) for the delivery of a vaccine is prepared using a formulation containing a starch, optionally, along with at least one additional matrix forming agent, preferably, a combination of gelatin and mannitol, where an immune response is induced in a patient in need thereof.
1. A fast-dissolving oral solid vaccine dosage form comprising:
(a) an immunogenic amount of an antigenic preparation;
(b) at least one immune response potentiating matrix forming agent; and
(c) at least one additional matrix forming agent,
wherein the at least one immune response potentiating matrix forming agent is a starch processed at a temperature of at least about 70° C.,
wherein the starch is in an amount of 5% to 80% by weight,
wherein the at least one additional matrix forming agent is selected from the group consisting of mannitol, gelatin or a combination of mannitol and gelatin,
wherein, when present, the gelatin is in an amount of 2.5% to 65% by weight, and the mannitol is in an amount of 5% to 80% by weight, and
wherein the dosage form facilitates oral cavity uptake of an antigen within said antigenic preparation.
2. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the starch is selected from the group consisting of native starch, modified starch, and combinations thereof.
3. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the dosage form disintegrates within 60 seconds after being placed in the oral cavity.
4. The fast-dissolving oral solid vaccine dosage form according to claim 3 , wherein the dosage form disintegrates within 30 seconds of being placed in the oral cavity.
5. The fast-dissolving oral solid vaccine dosage form according to claim 4 , wherein the dosage form disintegrates within 10 seconds of being placed in the oral cavity.
6. The fast-dissolving oral solid vaccine dosage form according to claim 5 , wherein the dosage form disintegrates within 5 seconds of being placed in the oral cavity.
7. The fast-dissolving oral solid vaccine dosage form according to claim 1 , prepared by freeze-drying.
8. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the at least one additional matrix forming agent is mannitol.
9. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the at least one additional matrix forming agent is gelatin.
10. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the at least one additional matrix forming agent comprises gelatin and mannitol.
11. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the starch is present in an amount of 7% to 75% by weight.
12. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the gelatin is present in an amount of 3% to 55%; the mannitol is present in an amount of 7% to 65%; and the starch is present in an amount of 7% to 75% by weight.
13. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein the at least one additional matrix forming agent further comprises a gum.
14. The fast-dissolving oral solid vaccine dosage form according to claim 13 , wherein the gum is xanthan gum.
15. The fast-dissolving oral solid vaccine dosage form according to claim 1 , further comprising a surfactant.
16. The fast-dissolving oral solid vaccine dosage form according to claim 15 , wherein the surfactant is selected from the group consisting of polysorbate 80 and poloxamer.
17. The fast-dissolving oral solid vaccine dosage form according to claim 1 , further comprising an adjuvant.
18. The fast-dissolving oral solid vaccine dosage form according to claim 1 , further comprising a mucoadhesive.
19. The fast-dissolving oral solid vaccine dosage form according to claim 1 , wherein an immune response is induced when administered to a patient by placement in the oral cavity.
20. The fast-dissolving oral solid vaccine dosage form according to claim 19 , wherein placement in the oral cavity is placement on or under the tongue or in the buccal or pharyngeal region.
21. A fast-dissolving oral solid vaccine dosage form comprising:
(a) an immunogenic amount of inactivated influenza virus;
(b) at least one immune response potentiating matrix forming agent; and
(c) at least one additional matrix forming agent,
wherein the at least one immune response potentiating matrix forming agent is a starch processed at a temperature of at least about 70° C.,
wherein the starch is in an amount of 5% to 80% by weight,
wherein the at least one additional matrix forming agent is selected from the group consisting of mannitol, gelatin or a combination of mannitol and gelatin,
wherein, when present, the gelatin is in an amount of 2.5% to 65% by weight, and the mannitol is in an amount of 5% to 80% by weight, and
wherein the dosage form facilitates oral cavity uptake of the inactivated influenza virus.
22. The fast-dissolving oral solid vaccine dosage form according to claim 21 , wherein the starch is selected from the group consisting of native starch, modified starch, and combinations thereof.
23. The fast-dissolving oral solid vaccine dosage form according to claim 21 , wherein the dosage form disintegrates within 60 seconds after being placed in the oral cavity.
24. The fast-dissolving oral solid vaccine dosage form according to claim 23 , wherein the dosage form disintegrates within 30 seconds of being placed in the oral cavity.
25. The fast-dissolving oral solid vaccine dosage form according to claim 24 , wherein the dosage form disintegrates within 10 seconds of being placed in the oral cavity.
26. The fast-dissolving oral solid vaccine dosage form according to claim 25 , wherein the dosage form disintegrates within 5 seconds of being placed in the oral cavity.
27. The fast-dissolving oral solid vaccine dosage form according to claim 21 , prepared by freeze-drying.
28. The fast-dissolving oral solid vaccine dosage form according to claim 21 , wherein the at least one additional matrix forming agent is mannitol.
29. The fast-dissolving oral solid vaccine dosage form according to claim 21 , wherein the at least one additional matrix forming agent is gelatin.
30. The fast-dissolving oral solid vaccine dosage form according to claim 21 , wherein the at least one additional matrix forming agent comprises gelatin and mannitol.
31. The fast-dissolving oral solid vaccine dosage form according to claim 30 , wherein the starch is present in an amount of 7% to 75% by weight.
32. The fast-dissolving oral solid vaccine dosage form according to claim 31 , wherein the gelatin is present in an amount of 3% to 55%; the mannitol is present in an amount of 7% to 65%; and the starch is present in an amount of 7% to 75% by weight.
33. The fast-dissolving oral solid vaccine dosage form according to claim 21 , wherein the at least one additional matrix forming agent further comprises a gum.
34. The fast-dissolving oral solid vaccine dosage form according to claim 33 , wherein the gum is xanthan gum.
35. The fast-dissolving oral solid vaccine dosage form according to claim 21 , further comprising a surfactant.
36. The fast-dissolving oral solid vaccine dosage form according to claim 35 , wherein the surfactant is selected from the group consisting of polysorbate 80 and poloxamer.
37. The fast-dissolving oral solid vaccine dosage form according to claim 21 , further comprising an adjuvant.
38. The fast-dissolving oral solid vaccine dosage form according to claim 21 , further comprising a mucoadhesive.
39. The fast-dissolving oral solid vaccine dosage form according to claim 21 , wherein an influenza specific IgG response is induced when administered to a patient by placement in the oral cavity.
40. The fast-dissolving oral solid vaccine dosage form according to claim 39 , wherein placement in the oral cavity is placement on or under the tongue or in the buccal or pharyngeal region.
41. A method of inducing an immune response in a patient, said method comprising the step of:
placing the fast-dissolving oral solid vaccine dosage form of claim 1 in the oral cavity of a person in need of the immune response.
42. The method of inducing an immune response in a patient according to claim 41 , wherein placement in the oral cavity is placement on or under the tongue or in the buccal or pharyngeal region.
43. A method of inducing an influenza specific antibody response in a patient, said method comprising the step of:
placing the fast-dissolving oral solid vaccine dosage form of claim 21 in the oral cavity of a person in need of the influenza specific antibody response.
44. The method of inducing an influenza specific antibody response in a patient according to claim 43 , wherein placement in the oral cavity is placement on or under the tongue or in the buccal or pharyngeal region.
45. The method of inducing an influenza specific antibody response in a patient according to claim 43 , wherein the influenza specific antibody response is an IgG response.
46. A fast-dissolving oral solid vaccine dosage form comprising:
(a) an immunogenic amount of an antigenic preparation;
(b) at least one immune response potentiating matrix forming agent; and
(c) at least one additional matrix forming agent,
wherein the at least one immune response potentiating matrix forming agent is a starch processed at a temperature of at least about 70°-75° C.,
wherein the starch is in an amount of 5% to 80% by weight,
wherein the at least one additional matrix forming agent is selected from the group consisting of mannitol, gelatin or a combination of mannitol and gelatin,
wherein, when present, the gelatin is a mammalian gelatin,
wherein, when present, the gelatin is in an amount of 2.5% to 65% by weight, and the mannitol is in an amount of 5% to 80% by weight, and
wherein the dosage form facilitates oral cavity uptake of an antigen within said antigenic preparation.