JP2012509269A5 - - Google Patents

Info

Publication number

JP2012509269A5

JP2012509269A5 JP2011536560A JP2011536560A JP2012509269A5 JP 2012509269 A5 JP2012509269 A5 JP 2012509269A5 JP 2011536560 A JP2011536560 A JP 2011536560A JP 2011536560 A JP2011536560 A JP 2011536560A JP 2012509269 A5 JP2012509269 A5 JP 2012509269A5

Authority

JP

Japan

Prior art keywords

cyclodextrin

antibody

formulation

seq

full length

Prior art date

2009-11-16

Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)

Pending

Links

• Espacenet
• Global Dossier
• Discuss

• 229920000858 Cyclodextrin Polymers 0.000 claims 42
• 238000000034 method Methods 0.000 claims 35
• 238000009472 formulation Methods 0.000 claims 32
• 239000000203 mixture Substances 0.000 claims 32
• HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 20
• 239000001116 FEMA 4028 Substances 0.000 claims 10
• 229960004853 betadex Drugs 0.000 claims 10
• 229940080345 gamma-cyclodextrin Drugs 0.000 claims 9
• 239000000546 pharmaceutical excipient Substances 0.000 claims 8
• 239000003814 drug Substances 0.000 claims 7
• 108090000623 proteins and genes Proteins 0.000 claims 5
• 102000004169 proteins and genes Human genes 0.000 claims 5
• 238000007920 subcutaneous administration Methods 0.000 claims 5
• BHKSYEZGBQDNRW-SCGRZTRASA-N C(CCC(=O)O)(=O)O.N[C@@H](CCCNC(N)=N)C(=O)O.N[C@@H](CCCNC(N)=N)C(=O)O Chemical compound C(CCC(=O)O)(=O)O.N[C@@H](CCCNC(N)=N)C(=O)O.N[C@@H](CCCNC(N)=N)C(=O)O BHKSYEZGBQDNRW-SCGRZTRASA-N 0.000 claims 4
• 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 4
• 238000000502 dialysis Methods 0.000 claims 4
• 229920000642 polymer Polymers 0.000 claims 4
• 239000000243 solution Substances 0.000 claims 4
• 102100022005 B-lymphocyte antigen CD20 Human genes 0.000 claims 3
• 101000897405 Homo sapiens B-lymphocyte antigen CD20 Proteins 0.000 claims 3
• 208000031981 Thrombocytopenic Idiopathic Purpura Diseases 0.000 claims 3
• 230000002776 aggregation Effects 0.000 claims 3
• 210000003719 b-lymphocyte Anatomy 0.000 claims 3
• 238000002347 injection Methods 0.000 claims 3
• 239000007924 injection Substances 0.000 claims 3
• 201000006417 multiple sclerosis Diseases 0.000 claims 3
• 206010021245 Idiopathic thrombocytopenic purpura Diseases 0.000 claims 2
• FBOZXECLQNJBKD-ZDUSSCGKSA-N L-methotrexate Chemical compound C=1N=C2N=C(N)N=C(N)C2=NC=1CN(C)C1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 FBOZXECLQNJBKD-ZDUSSCGKSA-N 0.000 claims 2
• 206010025323 Lymphomas Diseases 0.000 claims 2
• 206010028980 Neoplasm Diseases 0.000 claims 2
• 208000007400 Relapsing-Remitting Multiple Sclerosis Diseases 0.000 claims 2
• 238000004220 aggregation Methods 0.000 claims 2
• 201000003710 autoimmune thrombocytopenic purpura Diseases 0.000 claims 2
• 229920002521 macromolecule Polymers 0.000 claims 2
• 239000008194 pharmaceutical composition Substances 0.000 claims 2
• 238000001556 precipitation Methods 0.000 claims 2
• 238000002360 preparation method Methods 0.000 claims 2
• 206010039073 rheumatoid arthritis Diseases 0.000 claims 2
• 201000000596 systemic lupus erythematosus Diseases 0.000 claims 2
• DPVHGFAJLZWDOC-PVXXTIHASA-N (2r,3s,4s,5r,6r)-2-(hydroxymethyl)-6-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-3,4,5-triol;dihydrate Chemical compound O.O.O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 DPVHGFAJLZWDOC-PVXXTIHASA-N 0.000 claims 1
• FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
• XGWFJBFNAQHLEF-UHFFFAOYSA-N 9-anthroic acid Chemical compound C1=CC=C2C(C(=O)O)=C(C=CC=C3)C3=CC2=C1 XGWFJBFNAQHLEF-UHFFFAOYSA-N 0.000 claims 1
• 208000023275 Autoimmune disease Diseases 0.000 claims 1
• 206010050245 Autoimmune thrombocytopenia Diseases 0.000 claims 1
• 208000004736 B-Cell Leukemia Diseases 0.000 claims 1
• 208000003950 B-cell lymphoma Diseases 0.000 claims 1
• 201000009030 Carcinoma Diseases 0.000 claims 1
• VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
• 206010009900 Colitis ulcerative Diseases 0.000 claims 1
• 206010018364 Glomerulonephritis Diseases 0.000 claims 1
• 208000017604 Hodgkin disease Diseases 0.000 claims 1
• 208000010747 Hodgkins lymphoma Diseases 0.000 claims 1
• 208000010159 IgA glomerulonephritis Diseases 0.000 claims 1
• 206010021263 IgA nephropathy Diseases 0.000 claims 1
• DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
• 206010061218 Inflammation Diseases 0.000 claims 1
• 208000022559 Inflammatory bowel disease Diseases 0.000 claims 1
• 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
• 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 1
• 208000005777 Lupus Nephritis Diseases 0.000 claims 1
• 101000907840 Methylorubrum extorquens (strain ATCC 14718 / DSM 1338 / JCM 2805 / NCIMB 9133 / AM1) Glycerate dehydrogenase Proteins 0.000 claims 1
• 206010029240 Neuritis Diseases 0.000 claims 1
• 229910019142 PO4 Inorganic materials 0.000 claims 1
• 206010036105 Polyneuropathy Diseases 0.000 claims 1
• 229920001213 Polysorbate 20 Polymers 0.000 claims 1
• ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 1
• 201000004681 Psoriasis Diseases 0.000 claims 1
• 208000003782 Raynaud disease Diseases 0.000 claims 1
• 208000012322 Raynaud phenomenon Diseases 0.000 claims 1
• 208000021386 Sjogren Syndrome Diseases 0.000 claims 1
• VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 1
• 206010043561 Thrombocytopenic purpura Diseases 0.000 claims 1
• 201000007023 Thrombotic Thrombocytopenic Purpura Diseases 0.000 claims 1
• 108060008682 Tumor Necrosis Factor Proteins 0.000 claims 1
• 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims 1
• 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
• 206010047115 Vasculitis Diseases 0.000 claims 1
• 238000011481 absorbance measurement Methods 0.000 claims 1
• 238000005054 agglomeration Methods 0.000 claims 1
• 238000013019 agitation Methods 0.000 claims 1
• 150000001413 amino acids Chemical group 0.000 claims 1
• 239000005557 antagonist Substances 0.000 claims 1
• 238000003556 assay Methods 0.000 claims 1
• WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 1
• 235000011175 beta-cyclodextrine Nutrition 0.000 claims 1
• 201000011510 cancer Diseases 0.000 claims 1
• 208000019069 chronic childhood arthritis Diseases 0.000 claims 1
• 230000001684 chronic effect Effects 0.000 claims 1
• 206010012601 diabetes mellitus Diseases 0.000 claims 1
• 201000010099 disease Diseases 0.000 claims 1
• 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
• 238000000338 in vitro Methods 0.000 claims 1
• 230000004054 inflammatory process Effects 0.000 claims 1
• 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims 1
• 208000032839 leukemia Diseases 0.000 claims 1
• 210000004698 lymphocyte Anatomy 0.000 claims 1
• 229960000485 methotrexate Drugs 0.000 claims 1
• 206010028417 myasthenia gravis Diseases 0.000 claims 1
• 239000000825 pharmaceutical preparation Substances 0.000 claims 1
• NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
• 239000010452 phosphate Substances 0.000 claims 1
• 230000004962 physiological condition Effects 0.000 claims 1
• 238000006116 polymerization reaction Methods 0.000 claims 1
• 208000019629 polyneuritis Diseases 0.000 claims 1
• 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
• 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
• 229940068977 polysorbate 20 Drugs 0.000 claims 1
• 229910052700 potassium Inorganic materials 0.000 claims 1
• 239000011591 potassium Substances 0.000 claims 1
• 239000002244 precipitate Substances 0.000 claims 1
• 230000000306 recurrent effect Effects 0.000 claims 1
• 229960004641 rituximab Drugs 0.000 claims 1
• 229910052708 sodium Inorganic materials 0.000 claims 1
• 239000011734 sodium Substances 0.000 claims 1
• 235000017281 sodium acetate Nutrition 0.000 claims 1
• 239000001632 sodium acetate Substances 0.000 claims 1
• 230000007928 solubilization Effects 0.000 claims 1
• 238000005063 solubilization Methods 0.000 claims 1
• 230000001225 therapeutic effect Effects 0.000 claims 1
• 229940074409 trehalose dihydrate Drugs 0.000 claims 1
• 238000011179 visual inspection Methods 0.000 claims 1