METHOD FOR PREPARING ORAL FORM OF SUBSTANCE CONTAINING INSULIN Russian patent published in 2024 - IPC A61K38/28 A61K9/48 A61K47/22 A61K47/24 A61P3/00 

FIELD: medicine; pharmaceutics.

SUBSTANCE: group of inventions relates to a method of producing an oral form of a substance containing insulin, wherein crystalline recombinant insulin, an antioxidant selected from beta-carotene, astaxanthin, dihydroquercetin, abisil are mixed, an additional antioxidant, such as tocopherol acetate and/or ascorbic acid, a nonionic surfactant, phospholipids and sorbitol in a calculated amount, mixing obtained mixture with an organic solvent by stirring in a reactor under conditions of transition of the organic solvent into a gaseous state, removing it and obtaining a powder mass in which a phospholipid film is formed in the crystalline structure of sorbitol, then powder mass is milled to obtain fine powder with particle size of 160–200 mcm, which is encapsulated with addition of polyethylene glycol, and also relates to a substance for preventing complications of type 1 diabetes, obtained by said method, comprising crystalline recombinant insulin, an antioxidant selected from beta-carotene, astaxanthin, dihydroquercetin, abisil, an additional antioxidant, such as tocopherol acetate and/or ascorbic acid, a nonionic surfactant, sorbitol with a phospholipid film formed in its crystalline structure in an effective amount.

EFFECT: group of inventions provides creating an oral form of a substance containing insulin, which is suitable for preventing complications of type 1 diabetes.

9 cl, 1 dwg