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US 9,956,169 B2Granted
Oral vaccine fast-dissolving dosage form using starch
AssigneeR.P. Scherer Technologies, LLC
InventorsWei Tian, Rosie McLaughlin
Life of this patent
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Abstract
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.
Claims46
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.
6 more elements
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.
6 more elements
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.
7 more elements
Dependencies are inferred from the claim text.