FIELD: pharmaceuticals.
SUBSTANCE: invention relates to the pharmaceutical industry and is a method for producing a stable and homogeneous liquid composition, suitable for enteral administration, comprising a pancrelipase enzyme product and nutrients from a nutritional formula, comprising the following steps: obtaining a suspension of pancrelipase enzymes in an aqueous solution, including the steps of: reducing the size of the pancrelipase enzyme product, adding an aqueous solution having a neutral pH in an amount of less than 10 ml, mixing to form a suspension and holding it for a period of time greater than 5 minutes and mixing the suspension with the liquid nutritional formula to form a stable and homogeneous liquid composition, where the nutritional formula has a total content of fat, protein and carbohydrate nutrients from 10 to 35 g/100 ml, or has a total fat and protein nutrient content of 4.5 to 11.5 g/100 ml, or has a total fat nutrient content of 3.0 to 7.0 g/100 ml, or has a total content of protein nutrients from 1.3 to 6.3 g/100 ml, and the aqueous solution is purified water, deionised water, sterile water, saline solution, 0.9% NaCl or tap water.
EFFECT: invention provides stable and homogeneous compositions having lipase activity higher than 90% after 8 hours of storage at room temperature, calculated as the percentage of lipase activity in the composition after 8 hours to the lipase activity in the nutritional formula at time zero and which could be administered enterally without any phase separation and a tendency to blockage of the enteral probe for feeding or loss of stability.
20 cl, 16 ex, 19 tbl
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Authors
Dates
2018-04-19—Published
2014-03-13—Filed