Oral administration of immunologically active biomolecules and other therapeutic proteins
AssigneeUniversity of Cincinnati
InventorsJ. Gabriel Michael, Allen Litwin
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AssigneeUniversity of Cincinnati
InventorsJ. Gabriel Michael, Allen Litwin
Estimating the term…
An orally administrable therapeutic protein is provided by combining the therapeutic protein with a stabilizing agent in an aqueous solution. The solution is coated onto nonpareils and microencapsulated with a water emulsifiable enteric coating composition. The microcapsules are orally administered. The coating protects the protein as it passes through the stomach. Upon reaching the small intestines, the basic pH of the intestinal juices will dissolve the coating, allowing the protein to be released and induce antigen specific immune response which has the specificity of the native molecule. The stabilizing agent protects the therapeutic protein from denaturation during the encapsulation process. In addition to being immunogenic, when administered orally, encapsulated allergen has a therapeutic effect in the treatment of human allergies.
An orally administrable therapeutic composition comprising an immunogen microencapsulated in the complete absence of organic solvents with a water based enteric coating wherein said immunogen has an immunotherapeutic effect against an allergen in a warm blood animal.
An orally administrable therapeutic composition consisting essentially of an immunogen and at least one of an adjuvant which increases immunogenicity of said immunogen, a stabilizing sugar selected from the group consisting of lactose, trehalose and mannitol and a binding agent, microencapsulated in the complete absence of organic solvents with a water based enteric coating wherein said immunogen has an immunotherapeutic effect against an allergen in a warm blooded animal.
An orally administrable therapeutic composition consisting essentially of a ragweed allergen and optionally an adjuvant, a stabilizing sugar and a binding agent microencapsulated in the complete absence of organic solvents with a water based enteric coating wherein said composition is therapeutically effective at a dosage of less than or equal to 35 Arab a 1 units administered daily.
The therapeutic composition claimed in claim 31 wherein said adjuvant is selected from the group consisting of aluminum sulfate and aluminum hydroxide.
An orally administrable composition comprising an immunogen microencapsulated on particles of a pharmaceutically inert material having a first coating comprising said immunogen and a second coating comprising said enteric coating wherein said immunogen has an immunotherapeutic effect against an allergen in a warm blooded animal.
An orally administrable composition comprising
A composition according to claim 25 wherein said immunogen is a pollen allergen selected from the group consisting of ragweed, rye, June grass, orchard grass, sweet vernal grass, red top grass, timothy grass, yellow dock, wheat, corn, sagebrush, blue grass, California annual grass, pigweed, Bermuda grass, Russin thistle, mountain cedax, oak, box elder, sycamore, maple and elm.
Dependencies are inferred from the claim text.