Parenteral nutrition formulation with optimized amino acid and glucose content

Abstract

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 - 26 . (canceled) 
     
     
         27 : 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 a formulation reconstituted from the first and the second chamber comprises
 14.41-18.72 g/L L-Alanine,   8.01-10.40 g/L L-Arginine,   7.17-9.31 g/L Glycine,   3.34-4.34 g/L L-Histidine,   4.17-5.42 g/L L-Isoleucine,   5.08-6.60 g/L L-Leucine,   4.04-5.25 g/L L-Lysine,   2.78-3.61 g/L L-Methionine,   3.90-5.06 g/L L-Phenylalanine,   4.73-6.14 g/L L-Proline,   3.48-4.52 g/L L-Serine,   2.92-3.80 g/L L-Threonine,   1.25-1.62 g/L L-Tryptophan,   0.28-0.36 g/L L-Tyrosine,   4.04-5.25 g/L L-Valine, and   12.9-15.2% dextrose;
 or the formulation reconstituted from the first and the second chamber comprises 
   10.8-14.04 g/L L-Alanine,   6.01-7.80 g/L L-Arginine,   5.38-6.98 g/L Glycine,   2.50-3.25 g/L L-Histidine,   3.13-4.07 g/L L-Isoleucine,   3.81-4.95 g/L L-Leucine,   3.03-3.94 g/L L-Lysine,   2.09-2.71 g/L L-Methionine,   2.92-3.80 g/L L-Phenylalanine,   3.55-4.61 g/L L-Proline,   2.61-3.39 g/L L-Serine,   2.19-2.85 g/L L-Threonine,   0.94-1.22 g/L L-Tryptophan,   0.21-0.27 g/L L-Tyrosine,   3.03-3.93 g/L L-Valine, and   4.6-5.4% dextrose.   
     
     
         28 : The medical product according to  claim 27 , 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%,   
     
     
         29 : The medical product according to  claim 27 , wherein the formulation reconstituted from the first and the second chamber further comprises
 30-40 mEq/L sodium,   2.3-2.9 g/L potassium dihydrogen phosphate,   4.0-6.0 mEq/L magnesium,   64.0-102.0 mEq/L acetate,   3.9-5.0 g/L chloride as NaCl, and   3.9-5.1 mEq/L calcium.   
     
     
         30 : The medical product according to  claim 27 , wherein the dextrose is contained in a concentration of from 9.3%-10.9%. 
     
     
         31 : The medical product according to  claim 30 , wherein the total calorie content of the product is from 640 Kcal/L to 680 Kcal/L. 
     
     
         32 : The medical product according to  claim 27 , wherein the first chamber contains an amino acid formulation comprising
 18.63-22.78 g/L L-Alanine,   10.35-12.65 g/L L-Arginine,   9.27-11.33 g/L Glycine,   4.32-5.28 g/L L-Histidine,   5.40-6.60 g/L L-Isoleucine,   6.57-8.03 g/L L-Leucine,   5.22-6.39 g/L L-Lysine,   3.60-4.40 g/L L-Methionine,   5.04-6.16 g/L L-Phenylalanine,   6.12-7.48 g/L L-Proline,   4.50-5.50 g/L L-Serine,   3.78-4.62 g/L L-Threonine,   1.62-1.98 g/L L-Tryptophan,   0.36-0.44 g/L L-Tyrosine, and   5.22-6.38 g/L L-Valine,   and wherein the second chamber comprises a dextrose formulation in a concentration of between 11.9% and 13.1%.   
     
     
         33 : The medical product according to  claim 31 , wherein the total calorie content is from 365 Kcal/L to 455 Kcal/L, and the total nitrogen content is from 8.6 g/L to 11.2 g/L. 
     
     
         34 : The medical product according to  claim 31  for peripheral parenteral nutrition of a patient in need thereof. 
     
     
         35 : The medical product according to  claim 27 , 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. 
     
     
         36 : The medical product according to  claim 27 , wherein the first chamber further comprises electrolytes comprising sodium, potassium, phosphate, magnesium, acetate, and chloride. 
     
     
         37 : The medical product according to  claim 36 , 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.   
     
     
         38 : The medical product according to  claim 27 , wherein the second chamber further comprises from 11 to 14 mEq/L calcium. 
     
     
         39 : The medical product according to  claim 27 , wherein the second chamber comprises dextrose in a concentration of from 37.1% to 41.0%. 
     
     
         40 : The medical product according to  claim 39 , wherein the total calorie content of the product is from 780 Kcal/L to 810 Kcal/L. 
     
     
         41 : The medical product according to  claim 27 , wherein an injection site port tube is located on the second chamber, and an administration site port tube is located on the first chamber. 
     
     
         42 : The medical product according to  claim 27 , 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. 
     
     
         43 : The medical product according to  claim 27 , 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. 
     
     
         44 : The medical product according to  claim 27 , wherein the non-permanent peel seal between the first and the second chamber is arranged vertically. 
     
     
         45 : The medical product according to  claim 27 , wherein the volume ratio between the first and the second chamber is from 1:1 to 2.0:1. 
     
     
         46 : The medical product according to  claim 45 , wherein the volume ratio is between 1.5:1 and 1.8:1.