US2010061999A1PendingUtilityA1
Antihuman tnf-alpha antibody activity lowering inhibitor
Est. expiryMar 1, 2024(expired)· nominal 20-yr term from priority
Inventors:Takayuki Matsumoto
A61P 37/04A61P 31/00A61P 43/00A61P 31/06A61P 31/04A61K 31/70A61K 39/3955A61K 31/198A61K 38/02A61P 1/00A61K 31/047Y10S435/975A61P 1/04Y10S435/81
66
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Claims
Abstract
The present invention provides an antihuman TNF-α antibody activity lowering inhibitor comprising a protein source(s) and/or carbohydrate source(s), in the treatment of inflammatory bowel syndrome with repeated administration of anti-TNF-α antibody; and a kit preparation wherein a freeze-dried antihuman TNF-α antibody and the activity lowering inhibitor in the above repeated administration of the anti-TNF-α antibody are separately contained in a plastic container so that they can communicate with each other. According to the present invention, in the drug therapy to the patients with inflammatory bowel syndrome, therapeutic agents which inhibit the inflammation for long periods without accompanying serious side effects can be provided.
Claims
exact text as granted — not AI-modified1 . An antihuman TNF-α antibody activity lowering inhibitor comprising a protein source(s), carbohydrate source(s) or a combination thereof, in the treatment of inflammatory bowel syndrome with repeated administration of anti-TNF-α antibody.
2 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , wherein the protein source(s) is animal proteins, vegetable proteins or a combination thereof.
3 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , wherein the protein source(s) is milk proteins, soybean protein isolates or a combination thereof.
4 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , wherein the protein source(s) comprises an amino acid(s).
5 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , wherein the protein source(s) consists of an amino add(s) only.
6 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 5 , wherein the protein source(s) comprises the amino acids at least in the following contents by dry weight:
L-isoleucine
2.0 to 8.0
W/W %
L-leucine
4.0 to 15.0
W/W %
L-lysine
4.0 to 15.0
W/W %
L-methionine
2.0 to 6.0
W/W %
L-phenylalanine
4.0 to 12.0
W/W %
L-threonine
1.0 to 8.0
W/W %
L-triptophan
0.5 to 3.0
W/W %
L-valine
2.0 to 6.0
W/W %
L-histidine
1.0 to 8.0
W/W %
L-arginine
5.0 to 9.0
W/W %
L-alanine
4.0 to 8.0
W/W %
L-asparaginic acid
2.0 to 15.0
W/W %
L-glutamine
0 to 15.0
W/W %
Glycin
1.0 to 12.0
W/W %
L-proline
2.0 to 6.0
W/W %
L-serine
1.0 to 10.0
W/W %
L-tyrosine
0.1 to 3.0
W/W %
L-cystein
0 to 10.0
W/W %
L-glutaminic acid
0 to 10.0
W/W %.
7 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , comprising at least one kind of sugar(s) selected from the group consisting of glucose, fructose, maltose, sorbitol, xylitol and glycerin as the carbohydrate source(s).
8 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , further comprising a lipid source(s).
9 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 8 , wherein the lipid source(s) comprises fats containing at least one kind of ω3 fatty add(s), which is selected from the group consisting of α-linolenic acid, eicosapentaenoic add and docosahexaenoic acid.
10 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , wherein the protein source(s) is in an amount of 5 to 30 W/W % by dry weight; the carbohydrate source(s) is in an amount of 40 to 90 W/W % by dry weight; and the lipid source(s) is in an amount of 0 to 30 W/W % by dry weight.
11 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 10 , wherein amounts of the protein source(s), the carbohydrate source(s) and the lipid source(s) are the following amounts by dry weight:
Protein source(s);
L-isoleucine
0.2 to 1.5
W/W %
L-leucine
0.5 to 2.0
W/W %
L-lysine
0.5 to 2.0
W/W %
L-methionine
0.2 to 1.5
W/W %
L-phenylalanine
0.5 to 2.0
W/W %
L-threonine
0.2 to 1.5
W/W %
L-triptophan
0.05 to 0.5
W/W %
L-valine
0.2 to 1.5
W/W %
L-histidine
0.5 to 2.0
W/W %
L-arginine
0.5 to 2.5
W/W %
L-alanine
0.5 to 2.0
W/W %
L-asparaginic acid
1.0 to 4.0
W/W %
L-glutamine
1.0 to 4.0
W/W %
Glycin
0.2 to 1.5
W/W %
L-proline
0.2 to 1.5
W/W %
L-serine
0.5 to 2.5
W/W %
L-tyrosine
0.05 to 0.5
W/W %
Carbohydrate source(s);
Dextrin
70 to 85
W/W %
Lipid source(s);
Soybean oil
0.1 to 10
W/W %.
12 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , wherein the antihuman TNF-α antibody is a monoclonal antibody selected from the group consisting of a chimeric antibody, humanized antibody and human antibody, or an antibody consisting of the part thereof.
13 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 12 , wherein the antihuman TNF-α antibody is at least one selected from the group consisting of Infliximab, Adalimumab and Etanercept.
14 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 13 , wherein the antihuman TNF-α antibody is Infliximab.
15 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , wherein the inflammatory bowel syndrome is Crohn's disease.
16 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 15 , wherein Crohn's disease is in the active stage and/or it accompanies the external fistula.
17 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , which further has an immune deterioration inhibiting effect, infection preventing effect or a combination thereof.
18 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , which is orally or enterally administered.
19 . The antihuman TNF-α antibody activity lowering inhibitor according to claim 1 , which is administered in the central vein.
20 . A kit preparation wherein a freeze-dried antihuman. TNF-α antibody and the antihuman TNF-α antibody activity lowering inhibitor according to claim 1 in the repeated administration of the anti-TNF-α antibody are separately contained in a plastic container so that they can communicate with each other.
21 . An immune deterioration inhibitor and/or infection preventing agent in the repeated administration of the anti-TNF-α antibody, which comprises a protein source(s) and/or carbohydrate source(s) in the treatment of inflammatory bowel syndrome with the antihuman TNF-α antibody.
22 . The immune deterioration inhibitor and/or infection preventing agent according to claim 21 , wherein the antihuman TNF-α antibody is at least either one of Infliximab, Adalimumab or Etanercept.
23 . The immune deterioration inhibitor and/or infection preventing agent according to claim 22 , wherein the antihuman TNF-α antibody is Infliximab.Join the waitlist — get patent alerts
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