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US4491589A
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Amino acid solutions for parenteral nutrition and methods of formulation and use
Assignee: Columbia University
•
Filing: 1983-04-29
•
Granted: 1985-01-01
•
Expires: 2003-04-29
Abstract
Abstract For parenteral nutrition, an aqueous L-amino acid solution having an amino acid content consisting essentially of essential and non-essential amino acids in proportions for producing and maintaining, in a subject to whom the same is administered, a steady-state plasma amino acid pattern within established ranges for the normal subject's post-prandial plasma amino acid pattern.
Inventors
- 👤 Ralph B. Dell
- 👤 Robert W. Winters
- 👤 William C. Heird
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 02:26
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/01; A61P; A61P3/00
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
86 words
A method of supplying amino acids to a patient, comprising parenterally administering to said patient an aqueous amino acid solution having an amino acid content consisting essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 mM/dl L-valine
3.62-10.63 mM/dl L-leucine
1.76-4.12 mM/dl L-isoleucine
0.41-6.55 mM/dl L-lysine
0.55-1.66 mM/dl L-methionine
0-3.00 mM/dl L-cysteine
0.43-5.48 mM/dl L-histidine
1.07-2.09 mM/dl L-phenylalanine
0-1.32 mM/dl L-tyrosine
0.20-0.98 mM/dl L-tryptophan
1.46-6.76 mM/dl L-arginine
0.81-2.71 mM/dl L-serine
1.06-4.42 mM/dl L-proline
1.92-4.44 mM/dl glycine
1.30-4.66 mM/dl L-alanine
0-2.40 mM/dl L-aspartic acid
0.31-2.55 mM/dl L-glutamic acid.
______________________________________
Claim 2
Independent Claim
86 words
A method of supplying amino acids to a patient, comprising parenterally administering to said patient an aqueous amino acid solution having an amino acid content consisting essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 mM/dl L-valine
3.62-10.63 mM/dl L-leucine
1.76-4.12 mM/dl L-isoleucine
0.41-6.55 mM/dl L-lysine
0.55-1.66 mM/dl L-methionine
0-3.00 mM/dl L-cysteine
0.43-5.48 mM/dl L-histidine
1.07-2.09 mM/dl L-phenylalanine
0-1.32 mM/dl L-tyrosine
0.20-0.98 mM/dl L-tryptophan
1.46-6.76 mM/dl L-arginine
0.81-2.71 mM/dl L-serine
1.06-4.42 mM/dl L-proline
1.92-4.44 mM/dl glycine
1.30-4.66 mM/dl L-alanine
0-2.40 mM/dl L-aspartic acid
0.31-2.55 mM/dl L-glutamic acid.
______________________________________
Claim 3
Dependent Claim
72 words
A method according to claim 1, wherein said amino acid content consists essentially of ______________________________________
1.34-2.19 mM/dl L-threonine
3.03-3.61 " L-valine
3.62-7.04 " L-leucine
2.12-4.12 " L-isoleucine
0.78-4.82 " L-lysine
0.62-1.66 " L-methionine
0-3.00 " L-cysteine
0.59-2.63 " L-histidine
1.07-1.83 " L-phenylalanine
0.33-1.32 " L-tyrosine
0.25-0.98 " L-tryptophan
1.75-5.25 " L-arginine
0.91-2.71 " L-serine
1.48-4.42 " L-proline
1.92-2.88 " glycine
1.50-4.50 " L-alanine
0-2.40 " L-aspartic acid
0.85-2.55 " L-glutamic acid.
______________________________________
Claim 4
Dependent Claim
72 words
A method according to claim 1, wherein said amino acid content consists essentially of ______________________________________
1.03-1.69 mM/dl L-threonine
3.45-4.13 " L-valine
5.47-10.63 " L-leucine
1.76-3.42 " L-isoleucine
1.07-6.55 " L-lysine
0.58-1.58 " L-methionine
0-3.00 " L-cysteine
0.43-1.85 " L-histidine
1.10-1.88 " L-phenylalanine
0-0.44 " L-tyrosine
0.20-0.80 " L-trypotophan
1.46-4.36 " L-arginine
0.88-2.62 " L-serine
1.12-3.38 " L-proline
2.96-4.44 " glycine
1.56-4.66 " L-alanine
0-1.36 " L-aspartic acid
0.37-1.11 " L-glutamic acid.
______________________________________
Claim 5
Dependent Claim
72 words
A method according to claim 1, wherein said amino acid content consists essentially of ______________________________________
2.02-3.30 mM/dl L-threonine
3.17-3.79 " L-valine
4.17-8.09 " L-leucine
1.83-3.55 " L-isoleucine
0.41-2.51 " L-lysine
0.55-1.49 " L-methionine
0-3.00 " L-cysteine
1.28-5.48 " L-histidine
1.23-2.09 " L-phenylalanine
0.35-0.75 " L-tyrosine
0.20-0.80 " L-tryptophan
2.26-6.76 " L-arginine
0.81-2.43 " L-serine
1.06-3.18 " L-proline
2.46-3.70 " glycine
1.30-3.90 " L-alanine
0-1.20 " L-aspartic acid
0.31-0.93 " L-glutamic acid.
______________________________________
Claim 6
Dependent Claim
28 words
A method according to claim 1, wherein said solution has a molar ratio of total essential amino acids to total amino acids between about 0.58 and about 0.65.
Claim 7
Independent Claim
93 words
A method of supplying amino acids to a patient, comprising parenterally administering to said patient an aqueous solution of essential and non-essential amino acids having an essential amino acid content consisting essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 " L-valine
3.62-10.63
" L-leucine
1.76-4.12 " L-isoleucine
0.41-6.55 " L-lysine
0.55-1.66 " L-methionine
0-3.00 " L-cysteine
0.43-5.48 " L-histidine
1.07-2.09 " L-phenylalanine
0-1.32 " L-tyrosine
0.20-0.98 " L-tryptophan
______________________________________ and wherein said nonessential amino acids include one or more of the group consisting of L-arginine, L-serine, L-proline, glycine, L-alanine, L-aspartic acid, and L-glutamic acid.
Claim 8
Independent Claim
93 words
A method of supplying amino acids to a patient, comprising parenterally administering to said patient an aqueous solution of essential and non-essential amino acids having an essential amino acid content consisting essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 " L-valine
3.62-10.63
" L-leucine
1.76-4.12 " L-isoleucine
0.41-6.55 " L-lysine
0.55-1.66 " L-methionine
0-3.00 " L-cysteine
0.43-5.48 " L-histidine
1.07-2.09 " L-phenylalanine
0-1.32 " L-tyrosine
0.20-0.98 " L-tryptophan
______________________________________ and wherein said nonessential amino acids include one or more of the group consisting of L-arginine, L-serine, L-proline, glycine, L-alanine, L-aspartic acid, and L-glutamic acid.
Claim 9
Dependent Claim
80 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of amino acids wherein the amino acid content consists essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 mM/dl L-valine
3.62-10.63 mM/dl L-leucine
1.76-4.12 mM/dl L-isoleucine
0.41-6.55 mM/dl L-lysine
0.55-1.66 mM/dl L-methionine
0-3.00 mM/dl L-cysteine
0.43-5.48 mM/dl L-histidine
1.07-2.09 mM/dl L-phenylalanine
0-1.32 mM/dl L-tyrosine
0.20-0.98 mM/dl L-tryptophan
1.46-6.76 mM/dl L-arginine
0.81-2.71 mM/dl L-serine
1.06-4.42 mM/dl L-proline
1.92-4.44 mM/dl glycine
1.30-4.66 mM/dl L-alanine
0-2.40 mM/dl L-aspartic acid
0.31-2.55 mM/dl L-glutamic acid.
______________________________________
Claim 10
Dependent Claim
80 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of amino acids wherein the amino acid content consists essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 mM/dl L-valine
3.62-10.63 mM/dl L-leucine
1.76-4.12 mM/dl L-isoleucine
0.41-6.55 mM/dl L-lysine
0.55-1.66 mM/dl L-methionine
0-3.00 mM/dl L-cysteine
0.43-5.48 mM/dl L-histidine
1.07-2.09 mM/dl L-phenylalanine
0-1.32 mM/dl L-tyrosine
0.20-0.98 mM/dl L-tryptophan
1.46-6.76 mM/dl L-arginine
0.81-2.71 mM/dl L-serine
1.06-4.42 mM/dl L-proline
1.92-4.44 mM/dl glycine
1.30-4.66 mM/dl L-alanine
0-2.40 mM/dl L-aspartic acid
0.31-2.55 mM/dl L-glutamic acid.
______________________________________
Claim 11
Dependent Claim
73 words
A solution as defined in claim 7, wherein said amino acid content consists essentially of ______________________________________
1.34-2.19 mM/dl L-threonine
3.03-3.61 " L-valine
3.62-7.04 " L-leucine
2.12-4.12 " L-isoleucine
0.78-4.82 " L-lysine
0.62-1.66 " L-methionine
0-3.00 " L-cysteine
0.59-2.63 " L-histidine
1.07-1.83 " L-phenylalanine
0.33-1.32 " L-tyrosine
0.25-0.98 " L-tryptophan
1.75-5.25 " L-arginine
0.91-2.71 " L-serine
1.48-4.42 " L-proline
1.92-2.88 " glycine
1.50-4.50 " L-alanine
0-2.40 " L-aspartic acid
0.85-2.55 " L-glutamic acid.
______________________________________
Claim 12
Dependent Claim
73 words
A solution as defined in claim 7, wherein said amino acid content consists essentially of ______________________________________
1.03-1.69 mM/dl L-threonine
3.45-4.13 " L-valine
5.47-10.63 " L-leucine
1.76-3.42 " L-isoleucine
1.07-6.55 " L-lysine
0.58-1.58 " L-methionine
0-3.00 " L-cysteine
0.43-1.85 " L-histidine
1.10-1.88 " L-phenylalanine
0-0.44 " L-tyrosine
0.20-0.80 " L-trypotophan
1.46-4.36 " L-arginine
0.88-2.62 " L-serine
1.12-3.38 " L-proline
2.96-4.44 " glycine
1.56-4.66 " L-alanine
0-1.36 " L-aspartic acid
0.37-1.11 " L-glutamic acid.
______________________________________
Claim 13
Dependent Claim
73 words
A solution as defined in claim 7, wherein said amino acid content consists essentially of ______________________________________
2.02-3.30 mM/dl L-threonine
3.17-3.79 " L-valine
4.17-8.09 " L-leucine
1.83-3.55 " L-isoleucine
0.41-2.51 " L-lysine
0.55-1.49 " L-methionine
0-3.00 " L-cysteine
1.28-5.48 " L-histidine
1.23-2.09 " L-phenylalanine
0.35-0.75 " L-tyrosine
0.20-0.80 " L-tryptophan
2.26-6.76 " L-arginine
0.81-2.43 " L-serine
1.06-3.18 " L-proline
2.46-3.70 " glycine
1.30-3.90 " L-alanine
0-1.20 " L-aspartic acid
0.31-0.93 " L-glutamic acid.
______________________________________
Claim 14
Dependent Claim
26 words
A solution as defined in claim 7, having a molar ratio of total essential amino acids to total amino acids between about 0.58 and about 0.65.
Claim 15
Dependent Claim
130 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of amino acids having an amino acid content consisting essentially of essential and non-essential amino acids in proportions for producing and maintaining, in an infant to whom the same is administered, a steady-state plasma amino acid pattern within established ranges for the normal infant two-hour post-prandial plasma amino acid pattern, said content including the following amino acids in the following ranges: ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 mM/dl L-valine
3.62-10.63 mM/dl L-leucine
1.76-4.12 mM/dl L-isoleucine
0.41-6.55 mM/dl L-lysine
0.55-1.66 mM/dl L-methionine
0-3.00 mM/dl L-cysteine
0.43-5.48 mM/dl L-histidine
1.07-2.09 mM/dl L-phenylalanine
0-1.32 mM/dl L-tyrosine
0.20-0.98 mM/dl L-tryptophan
1.46-6.76 mM/dl L-arginine
0.81-2.71 mM/dl L-serine
1.06-4.42 mM/dl L-proline
1.92-4.44 mM/dl glycine
1.30-4.66 mM/dl L-alanine
0-2.40 mM/dl L-aspartic acid
0.31-2.55 mM/dl L-glutamic acid.
______________________________________
Claim 16
Dependent Claim
130 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of amino acids having an amino acid content consisting essentially of essential and non-essential amino acids in proportions for producing and maintaining, in an infant to whom the same is administered, a steady-state plasma amino acid pattern within established ranges for the normal infant two-hour post-prandial plasma amino acid pattern, said content including the following amino acids in the following ranges: ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 mM/dl L-valine
3.62-10.63 mM/dl L-leucine
1.76-4.12 mM/dl L-isoleucine
0.41-6.55 mM/dl L-lysine
0.55-1.66 mM/dl L-methionine
0-3.00 mM/dl L-cysteine
0.43-5.48 mM/dl L-histidine
1.07-2.09 mM/dl L-phenylalanine
0-1.32 mM/dl L-tyrosine
0.20-0.98 mM/dl L-tryptophan
1.46-6.76 mM/dl L-arginine
0.81-2.71 mM/dl L-serine
1.06-4.42 mM/dl L-proline
1.92-4.44 mM/dl glycine
1.30-4.66 mM/dl L-alanine
0-2.40 mM/dl L-aspartic acid
0.31-2.55 mM/dl L-glutamic acid.
______________________________________
Claim 17
Dependent Claim
86 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of essential and non-essential amino acids wherein the essential amino acid content consists essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 " L-valine
3.62-10.63
" L-leucine
1.76-4.12 " L-isoleucine
0.41-6.55 " L-lysine
0.55-1.66 " L-methionine
0-3.00 " L-cysteine
0.43-5.48 " L-histidine
1.07-2.09 " L-phenylalanine
0-1.32 " L-tyrosine
0.20-0.98 " L-tryptophan
______________________________________ and wherein said non-essential amino acids include one or more of the group consisting of L-arginine, L-serine, L-proline, glycine, L-alanine, L-aspartic acid, and L-glutamic acid.
Claim 18
Dependent Claim
86 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of essential and non-essential amino acids wherein the essential amino acid content consists essentially of ______________________________________
1.03-3.30 mM/dl L-threonine
3.03-4.13 " L-valine
3.62-10.63
" L-leucine
1.76-4.12 " L-isoleucine
0.41-6.55 " L-lysine
0.55-1.66 " L-methionine
0-3.00 " L-cysteine
0.43-5.48 " L-histidine
1.07-2.09 " L-phenylalanine
0-1.32 " L-tyrosine
0.20-0.98 " L-tryptophan
______________________________________ and wherein said non-essential amino acids include one or more of the group consisting of L-arginine, L-serine, L-proline, glycine, L-alanine, L-aspartic acid, and L-glutamic acid.
Claim 19
Dependent Claim
92 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of essential and non-essential amino acids wherein the amino acids are present in the following relative proportions as expressed in terms of moles: ______________________________________
L-threonine 2.60 8.25
L-valine 7.58 10.32
L-leucine 9.05 26.58
L-isoleucine 4.40 10.30
L-lysine 1.02 16.40
L-methionine 1.38 4.15
L-cysteine 0 7.50
L-histidine 1.08 13.70
L-phenylalanine 2.68 5.22
L-tyrosine 0 3.30
L-tryptophan 0.50 2.45
L-arginine 3.65 16.90
L-serine 2.02 6.80
L-proline 2.65 11.05
glycine 4.80 11.10
L-alanine 3.25 11.65
L-aspartic acid 0 6.00
L-glutamic acid 0.78 6.38
______________________________________
Claim 20
Dependent Claim
92 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of essential and non-essential amino acids wherein the amino acids are present in the following relative proportions as expressed in terms of moles: ______________________________________
L-threonine 2.60 8.25
L-valine 7.58 10.32
L-leucine 9.05 26.58
L-isoleucine 4.40 10.30
L-lysine 1.02 16.40
L-methionine 1.38 4.15
L-cysteine 0 7.50
L-histidine 1.08 13.70
L-phenylalanine 2.68 5.22
L-tyrosine 0 3.30
L-tryptophan 0.50 2.45
L-arginine 3.65 16.90
L-serine 2.02 6.80
L-proline 2.65 11.05
glycine 4.80 11.10
L-alanine 3.25 11.65
L-aspartic acid 0 6.00
L-glutamic acid 0.78 6.38
______________________________________
Claim 21
Dependent Claim
43 words
An amino acid solution according to claim 14 wherein one or more of said amino acids is present in the same relative mole proportions in the form of one or more of their pharmaceutically acceptable salts, keto acid analogs, dipeptides or N-acetyl derivatives.
Claim 22
Dependent Claim
18 words
An amino acid solution according to claim 14 wherein said amino acids are present in pharmaceutically acceptable amounts.
Claim 23
Dependent Claim
92 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of essential and non-essential amino acids wherein the essential amino acids are present in the following relative proportions as expressed in terms of moles: ______________________________________
L-threonine 2.60 8.25
L-valine 7.58 10.32
L-leucine 9.05 26.58
L-isoleucine 4.40 10.30
L-lysine 1.02 16.40
L-methionine 1.38 4.15
L-cysteine 0 7.50
L-histidine 1.08 13.70
L-phenylalanine 2.68 5.22
L-tyrosine 0 3.30
L-tryptophan 0.50 2.45
______________________________________ and wherein the molar ratio of total essential amino acids to total amino acids is in the range from 0.50 to 0.70.
Claim 24
Dependent Claim
92 words
An amino acid solution for parenteral nutrition comprising an aqueous solution of essential and non-essential amino acids wherein the essential amino acids are present in the following relative proportions as expressed in terms of moles: ______________________________________
L-threonine 2.60 8.25
L-valine 7.58 10.32
L-leucine 9.05 26.58
L-isoleucine 4.40 10.30
L-lysine 1.02 16.40
L-methionine 1.38 4.15
L-cysteine 0 7.50
L-histidine 1.08 13.70
L-phenylalanine 2.68 5.22
L-tyrosine 0 3.30
L-tryptophan 0.50 2.45
______________________________________ and wherein the molar ratio of total essential amino acids to total amino acids is in the range from 0.50 to 0.70.
Claim 25
Dependent Claim
43 words
An amino acid solution according to claim 17 wherein one or more of said amino acids is present in the same relative mole proportions in the form of one or more of their pharmaceutically acceptable salts, keto acid analogs, dipeptides or N-acetyl derivatives.
Claim 26
Dependent Claim
24 words
An amino acid solution according to claim 18 wherein said solution further comprises sufficient non-specific nonessential amino acids to provide adequate nitrogen for nutrition.
Claim 27
Independent Claim
106 words
A method of providing nutrition to a patient for promoting growth of or maintaining lean body mass, comprising administering to said patient an aqueous amino acid solution having an amino acid content consisting essentially of amino acids in the following relative proportions as expressed in terms of moles: ______________________________________
L-threonine 2.60 8.25
L-valine 7.58 10.32
L-leucine 9.05 26.58
L-isoleucine 4.40 10.30
L-lysine 1.02 16.40
L-methionine 1.38 4.15
L-cysteine 0 7.50
L-histidine 1.08 13.70
L-phenylalanine 2.68 5.22
L-tyrosine 0 3.30
L-tryptophan 0.50 2.45
L-arginine 3.65 16.90
L-serine 2.02 6.80
L-proline 2.65 11.05
glycine 4.80 11.10
L-alanine 3.25 11.65
L-aspartic acid 0 6.00
L-glutamic acid 0.78 6.38
______________________________________
Claim 28
Independent Claim
106 words
A method of providing nutrition to a patient for promoting growth of or maintaining lean body mass, comprising administering to said patient an aqueous amino acid solution having an amino acid content consisting essentially of amino acids in the following relative proportions as expressed in terms of moles: ______________________________________
L-threonine 2.60 8.25
L-valine 7.58 10.32
L-leucine 9.05 26.58
L-isoleucine 4.40 10.30
L-lysine 1.02 16.40
L-methionine 1.38 4.15
L-cysteine 0 7.50
L-histidine 1.08 13.70
L-phenylalanine 2.68 5.22
L-tyrosine 0 3.30
L-tryptophan 0.50 2.45
L-arginine 3.65 16.90
L-serine 2.02 6.80
L-proline 2.65 11.05
glycine 4.80 11.10
L-alanine 3.25 11.65
L-aspartic acid 0 6.00
L-glutamic acid 0.78 6.38
______________________________________
Claim 29
Dependent Claim
43 words
An amino acid solution according to claim 20 wherein one or more of said amino acids is present in the same relative mole proportions in the form of one or more of their pharmaceutically acceptable salts, keto acid analogs, dipeptides or N-acetyl derivatives.
Claim 30
Dependent Claim
18 words
An amino acid solution according to claim 20 wherein said amino acids are present in pharmaceutically acceptable amounts.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-01-01 | 1988-07-02 | 1989-01-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-01-01 | 1992-07-02 | 1993-01-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-01-01 | 1996-07-02 | 1997-01-01 | $7700.00 | Window Closed / Lapsed |