Orally administrable therapeutic proteins and method of making

A - Human Necessities – 61 – K

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A61K 39/35 (2006.01) A61K 9/50 (2006.01) A61K 38/17 (2006.01) A61K 38/39 (2006.01) A61K 38/48 (2006.01) A61K 39/00 (2006.01) A61K 39/36 (2006.01) A61K 47/42 (2006.01) A61P 37/08 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2110899

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 a nonpareil 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. The stabilizing agent will protect the therapeutic protein during the encapsulation process and inhibit proteolytic enzymes in the small intestines thereby allowing the therapeutic protein to reach lymphoid tissue in the small intestines.

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