FIELD: medicine.
SUBSTANCE: invention refers to medicine. What is presented is a solid oral pharmaceutical composition containing 0.01÷20 wt % IN-105, approximately 10÷60 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 5÷500 mg. There are presented the solid pharmaceutical composition stable within the temperature range 2-40°C 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
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Authors
Dates
2012-06-20—Published
2008-10-16—Filed