SOLID PHARMACEUTICAL COMPOSITION (VERSIONS) AND METHOD FOR CONTROLLING GLUCOSE CONCENTRATION THEREWITH, METHOD FOR PREPARING SOLID PHARMACEUTICAL COMPOSITIONS (VERSIONS), TABLET (VERSIONS) AND METHOD FOR MAKING AMORPHOUS PARTICLES

摘要

FIELD: medicine. ^ SUBSTANCE: invention refers to medicine. What is presented is a solid oral pharmaceutical composition containing 0.0120 wt % IN-105, approximately 1060 wt % of saturated or unsaturated C4-C12 fatty acids, their esters and salts and at least one pharmaceutically acceptable excipient specified in a group containing at least 10 wt % of an aerating agent, 10 wt % of mannitol and 0.5 wt % of a lubricant. There are presented a method for controlling the blood glucose concentration with said composition, methods for preparing it and a tablet of weight 5500 mg. There are presented the solid pharmaceutical composition stable within the temperature range 2-40C and different relative humidity values for at least 6 months and an insulinotropic pharmaceutical composition with three-time lower mitogenicity in comparison with a native analogue containing said composition. What is also presented is a method for making amorphous spray-dried particles. ^ EFFECT: invention provides preparing the oral pharmaceutical composition containing conjugated insulin of higher bioavailability and lower mitogenicity. ^ 65 cl, 16 dwg, 16 tbl, 14 ex