FIELD: food industry.
SUBSTANCE: group of inventions relates to a digestive enzyme composition, a method for producing such a composition, and a method for treating a pediatric or adult patient. Digestive enzyme composition contains a pancrelipase enteric-coated product in a therapeutically effective amount, an administrable nutrient medium, a pharmaceutically acceptable low viscosity oil ingredient for enteral administration. Said low viscosity oil ingredient is selected from a group consisting of vegetable oils, synthetic oils, fatty acids or mixtures thereof, and said nutrient medium is a nutrient mixture or soft food product. Pancrelipase product is an enteric-coated pancrelipase product, in a therapeutically effective amount of approximately 10,000 lipase ME (international units) Pharm. USA (US Pharmacopeia) or more, administrable nutrient medium is present in an amount of about 2 ml to about 15 ml for each from about 5,000 to about 20,000 lipase ME Farm. US pancrelipase product, the low viscosity oil ingredient is present in an amount from about 5 % to about 25 % v/v of the administrable nutrient medium, and a G probe used for enteral administration has an internal diameter of at least about 18 Fr (French scale units; 6 mm). Method is also disclosed for preparing a digestive enzyme composition, comprising mixing an enteric-coated pancrelipase product, an administrable nutrient medium, a pharmaceutically acceptable low viscosity oil ingredient. Method of treating a pediatric or adult patient in need of said digestive enzyme composition, including enteral administration to a patient of said digestive enzyme composition, is also provided.
EFFECT: group of inventions provides effective enteral administration of high dosages of large-size digestive enzyme particles without damaging the active ingredient.
15 cl, 7 tbl, 5 ex
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Authors
Dates
2019-02-13—Published
2014-08-04—Filed