Parenteral nutrition formulation with optimized amino acid and glucose content
The present disclosure relates to a sterile medical product for parenteral nutrition comprising a polymeric container having at least a first and a second chamber which are separated by a non-permanent peel seal, wherein the first chamber contains a composition of amino acids and optionally electrolytes, and wherein the second chamber contains a dextrose solution, and wherein the product is characterized by a high protein (nitrogen) content per volume. The reconstituted solution is configured to be administered peripherally or centrally for the treatment of patients suffering from malnutrition and/or having a need for increased uptake of amino acids.
1. A sterile medical product for parenteral administration comprising a polymeric container having a first and second chamber which are separated by a non-permanent peel seal, wherein the first chamber contains an amino acid formulation comprising
23.29-28.47
g/L
L-Alanine,
12.94-15.82
g/L
L-Arginine,
11.58-14.16
g/L
Glycine,
5.40-6.60
g/L
L-Histidine,
6.75-8.24
g/L
L-Isoleucine,
8.22-10.04
g/L
L-Leucine,
6.53-7.98
g/L
L-Lysine,
4.50-5.50
g/L
L-Methionine,
6.30-7.70
g/L
L-Phenylalanine,
7.65-9.35
g/L
L-Proline,
5.63-6.88
g/L
L-Serine,
4.72-5.77
g/L
L-Threonine,
2.02-2.47
g/L
L-Tryptophan,
0.45-0.54
g/L
L-Tyrosine, and
6.53-7.98
g/L
L-Valine,
and wherein the second chamber comprises a dextrose formulation having a pH of from 3.2 to 6.5 at 25° C., wherein the dextrose is provided in a concentration of between 26.6% and 41.0%.
2. The medical product according to claim 1 , wherein the first chamber further comprises electrolytes comprising sodium, potassium, phosphate, magnesium, acetate, and chloride.
3. The medical product according to claim 2 , wherein the electrolytes are present in an amount of from
49.0-60.0
mEq/L
sodium,
3.67-4.49
g/L
potassium phosphate dibasic,
7.0-9.0
mEq/L
magnesium,
103.0-155.0
mEq/L
acetate, and
5.9-7.2
g/L
chloride as NaCl.
4. The medical product according to claim 1 , wherein the second chamber further comprises from 11 to 14 mEq/L calcium.
5. The medical product according to claim 1 , wherein the second chamber comprises dextrose in a concentration of from 26.6% to 29.4%.
6. The medical product according to claim 1 , wherein the second chamber comprises dextrose in a concentration of from 37.1% to 41.0%.
7. The medical product according to claim 6 , wherein the total calorie content of the product is from 780 Kcal/L to 810 Kcal/L.
8. The medical product according to claim 1 , wherein the total nitrogen content of the product is from 12.90 g/L to 13.50 g/L.
9. The medical product according to claim 1 for central parenteral nutrition of a patient in need thereof.
10. The medical product according to claim 1 , wherein the pH in the first chamber is from 5.0 to 7.0.
11. The medical product according to claim 1 , wherein the pH of a solution reconstituted from the formulations contained in the first and the second chambers is from 4.5 to 7.0.
12. The medical product according to claim 1 , wherein the non-permanent peel seal between the first and the second chamber is arranged vertically.
13. The medical product according to claim 1 , wherein the volume ratio between the first and the second chamber is from 1:1 to 2.0:1.
14. The medical product according to claim 13 , wherein the volume ratio is between 1.5:1 and 1.8:1.
15. The medical product according to claim 1 , wherein an injection site port tube is located on the second chamber, and an administration site port tube is located on the first chamber.
16. The medical product according to claim 1 , wherein the product comprises a third chamber which is separated from the first and/or the second chamber by one or two non-permanent peel seals, and wherein the third chamber comprises a lipid emulsion which upon breaking the one or two non-permanent peel seal(s) can be admixed with the formulation of the first and/or the second chamber before administration.
17. The medical product according to claim 1 , wherein the product is terminally moist heat-sterilized.
18. A solution reconstituted from the medical product according to claim 1 for providing parenteral nutrition to a patient whose alimentary tract cannot be used, and/or whose gastrointestinal absorption of protein is impaired, and/or whose metabolic requirements for protein are increased.