Aqueous solution for the parenteral nutrition

Details Aqueous solution for the parenteral nutrition Aqueous solution for the parenteral nutrition

2000-06-26

2002-01-08

Henley, III, Raymond (Department: 1614)

Drug, bio-affecting and body treating compositions

Inorganic active ingredient containing

Phosphorus or phosphorus compound

C514S400000, C514S419000, C514S561000, C514S565000

Reexamination Certificate

active

06337094

ABSTRACT:

The invention refers to an aqueous solution for the parenteral nutrition of mammals.
EP 0 671 166 A2 discloses an infusion preparation for nutrient supply use. It comprises sugar, amino acids, electrolytes and fat emulsion. The examples disclose several patterns of amino acids.
In the same way DE 43 16 326 C1 discloses different patents of amino acids for the total parenteral nutrition by perivenous application.
Similar to that disclosure of DE 43 16 326 C1, DE 39 16 903 A1 discloses an aqueous composition of parenteral nutrition which is in particular defined by a specific amino acid pattern.
R. Zander, Infusionsther. Transfusionsmed. 1993;20:217-235 discloses a specific base concept for infusion solutions. In particular, the concepts of base excess (BE mmol/l and BE pot. mmol/1) should be introduced, in order to give an indication of potential alterations in the HCO
3−
pool after infusion and metabolism of infusion solutions. This also applies to blood derivatives, where transfusion acidosis as well as alkalosis may occur, and in hemodialysis and peritoneal dialysis where the occurrence of acidosis and alkalosis during therapy need to be reckoned with. The above mentioned patterns of amino acid solutions partially available in the market do not fulfill the requirements of the concept of a base excess.
Thus, it was the object of the invention to provide an aqueous solution for the parenteral nutrition of mammals fulfilling the requirements of said concept.
The solution of the above mentioned object is fulfilled in a first embodiment by an aqueous solution of the parenteral nutrition of mammals consisting of
a) a pattern of amino acids calculated on the basis of 100 g/l of amino acids
Isoleucine
4.0-5.5
g/l
Leucine
8.0-10.0
g/l
Lysine
6.0-8.0
g/l
Methionine
4.0-6.0
g/l
Phenylalanine
4.0-6.0
g/l
Threonine
4.0-6.0
g/l
Tryptophane
1.0-2.0
g/l
Valine
6.0-8.0
g/l
Arginine
10.0-12.0
g/l
Histidine
1.5-3.5
g/l
Alanine
9.0-12.0
g/l
Aminoacetic Acid (Glycine)
11.0-16.0
g/l
Asparagine
0-1.0
g/l
Aspartic Acid
5.5-8.0
g/l
Acetylcysteine
0-2.5
g/l
Glutamic Acid
6.0-10.0
g/l
Ornithine
0-1.0
g/l
Proline
4.0-6.0
g/l
Serine
1.0-3.0
g/l
Tyrosine*
01.-0.5
g/l
*as Acetyltyrosine
0-2.0
g/l
Taurine
0-4
g/l
b) a pattern of electrolytes of
Sodium
0-100.0
mmol/l
Potassium
0-80.0
mmol/l
Magnesium
0-8.0
mmol/l
Calcium
0-8.0
mmol/l and/or
Zinc
0-0.08
mmol/l
Phosphate
0-20.0
mmol/l
Chloride
0-120.0
mmol/l
Acetate
0-120.0
mmol/l
Citric acid
0-10.0
mmol/l
Malate
0-80.0
mmol/l
Lactate
0-10.0
mmol/l
Glycerophosphate
0-30.0
mmol/l and/or
Gluconate
0-120.0
mmol/l
c) optionally a carbohydrate solution (sugar) and/or fat emulsion.
Parenteral nutrition must supply the body with all the components necessary for growth and tissue generation. The amino acids play a prominent role since they are the basic components for protein synthesis. In order to ensure optimal utilization of the amino acids, the administration of an additional energy source is required. This can be fulfilled partly in the form of the optionally used carbohydrates. As glucose can be utilized directly, it is the carbohydrate of choice, but in the same way Xylitol can be utilized instead of or partially substituting glucose.
However, the prior art of course discloses the use of other carbohydrates.
Electrolytes are administered for the maintenance of metabolic and physiologic function. They ensure an adequate parenteral nutritional supply with the aqueous solution.


REFERENCES:
patent: 5206269 (1993-04-01), Ludwig et al.
patent: 3916903 (1991-02-01), None
patent: 4316326 (1994-06-01), None
patent: 0671166 (1995-09-01), None
patent: 0705542 (1996-04-01), None
patent: 0712583 (1996-05-01), None

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