METHODS OF PRODUCING COMPOSITIONS WITH IMPROVED SAFETY PROFILE CONTAINING PANCREATIN, AND COMPOSITIONS SUITABLE FOR PHARMACEUTICAL USE Russian patent published in 2020 - IPC A61K9/20 A61K9/16 A61K38/18 A61K47/44 A61K47/34 A61P1/18 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to the pharmaceutical industry, specifically to a method of producing a solid and a semi-solid composition. Method of producing a solid or semi-solid composition comprising a step of treating a mixture comprising pancreatin and/or a mixture of digestive enzymes obtained from a mammal, a surface-active component, antioxidant, polymer additives selected from hydrophilic polymers with melting points or glass transition temperatures of 50–160 °C, wherein weight of components in amount of 100 wt. %; ratio of polymer additive to surface-active component ranges from 0.4 (2:5) to 1.5 (3:2); mixture is treated by molding from melt at temperature of 90–130 °C for a period of time from 30 s to 45 min. Solid or semi-solid composition for preventing or treating diseases selected from digestive disorders, pancreatic exocrine insufficiency, pancreatitis, mucoviscidosis, type I and/or type II diabetes. Pharmaceutical composition for preventing or treating diseases selected from digestive disorders, pancreatic exocrine insufficiency, pancreatitis, mucoviscidosis, type I diabetes and/or type II diabetes. Solid or semi-solid composition or pharmaceutical composition for preventing or treating diseases selected from digestive disorders, pancreas exocrine insufficiency, pancreatitis, mucoviscidosis, type I and/or type II diabetes.

EFFECT: method described above enables to reduce undesirable contamination of the composition while maintaining enzymatic activity.

22 cl, 2 dwg, 19 tbl, 60 ex