Composition containing digestive enzymes and nutrients suitable for enteral administration
AssigneeAptalis Pharma Limited
InventorsVincenza PIRONTI, Emanuela RONDA, Luigi BOLTRI
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Abstract
The present invention provides a process for the preparation of a stable and homogeneous liquid composition that is suitable for enteral administration comprising a digestive enzyme product and nutrients from a nutritional formula having specific amount of nutrients. The invention further provides a method for efficiently and effectively administering a therapeutically effective dose of the stable and homogeneous liquid composition by means of an enteral tube.
Claims21
A process for the preparation of a stable and homogenous composition that is suitable for enteral administration comprising a digestive enzyme product and nutrients from a nutritional formula, said process comprising the following steps:
- a) preparing a suspension of digestive enzymes in aqueous solution comprising the step of:
- a.1) reducing the size of the digestive enzyme product;
- a.2) adding an aqueous solution;
- a.3) mixing to form the suspension;
- and
- a.4) keeping it for a period of time greater than about 5 minutes;
- and
- b) mixing the suspension with a liquid nutritional formula to form the stable and homogeneous liquid composition;
- wherein the nutritional formula has a total fat and protein and carbohydrate nutrient content from about 10 to about 35 g/100 mL, or has a total fat and protein nutrient content from about 4.5 to about 11.5 g/100 mL, or has a total fat nutrient content from about 3.0 to about 7.0 g/100 mL, or has a total protein nutrient content from about 1.3 to about 6.3 g/100 mL.
A stable and homogeneous liquid composition that is suitable for enteral administration comprising a digestive enzyme product and nutrients from a nutritional formula, wherein the nutritional formula has a total fat and protein and carbohydrate nutrient content from about 10 to about 35 g/100 mL, or has a total fat and protein nutrient content from about 4.5 to about 11.5 g/100 mL, or has a total fat nutrient content from about 3.0 to about 7.0 g/100 mL, or has a total protein nutrient content from about 1.3 to about 6.3 g/100 mL.
A method of administration to a patient in need thereof of a composition comprising digestive enzyme product and nutrients from nutritional formula, comprising the following steps:
- a) reducing the size of the digestive enzyme product;
- b) adding an aqueous solution;
- c) mixing to form the suspension;
- d) keeping it for a period of time greater than about 5 minutes;
- e) mixing the suspension of step d) with a liquid nutritional formula to form the stable and homogenous liquid composition;
- and
- f) dispensing the composition from a dispensing bag to the patient through an enteral tube;
- wherein the nutritional formula has a total fat and protein and carbohydrate nutrient content from about 10 to about 35 g/100 mL, or has a total fat and protein nutrient content from about 4.5 to about 11.5 g/100 mL, or has a total fat nutrient content from about 3.0 to about 7.0 g/100 mL, or has a total protein nutrient content from about 1.3 to about 6.3 g/100 mL.
Dependencies are inferred from the claim text.