JP2015231997A5 - - Google Patents

Info

Publication number

JP2015231997A5

JP2015231997A5 JP2015132999A JP2015132999A JP2015231997A5 JP 2015231997 A5 JP2015231997 A5 JP 2015231997A5 JP 2015132999 A JP2015132999 A JP 2015132999A JP 2015132999 A JP2015132999 A JP 2015132999A JP 2015231997 A5 JP2015231997 A5 JP 2015231997A5

Authority

JP

Japan

Prior art keywords

formulation

histidine

mannitol

formulation according

preparation according

Prior art date

2015-07-01

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.)

Withdrawn

Links

• Espacenet
• Global Dossier
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• 238000002360 preparation method Methods 0.000 claims description 17
• 238000009472 formulation Methods 0.000 claims description 9
• HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 9
• 239000000203 mixture Substances 0.000 claims description 9
• FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 7
• 229930195725 Mannitol Natural products 0.000 claims description 7
• 239000000594 mannitol Substances 0.000 claims description 7
• 235000010355 mannitol Nutrition 0.000 claims description 7
• 239000007853 buffer solution Substances 0.000 claims description 5
• 229960001838 canakinumab Drugs 0.000 claims description 5
• 239000003381 stabilizer Substances 0.000 claims description 4
• 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 3
• 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 3
• 229920000053 polysorbate 80 Polymers 0.000 claims description 3
• 229940068968 polysorbate 80 Drugs 0.000 claims description 3
• 239000004067 bulking agent Substances 0.000 claims description 2
• 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
• 239000000825 pharmaceutical preparation Substances 0.000 claims description 2
• 239000003755 preservative agent Substances 0.000 claims description 2
• 150000003839 salts Chemical class 0.000 claims description 2
• 239000004094 surface-active agent Substances 0.000 claims description 2
• 238000002347 injection Methods 0.000 claims 2
• 239000007924 injection Substances 0.000 claims 2
• 239000007788 liquid Substances 0.000 claims 2
• 239000012669 liquid formulation Substances 0.000 claims 2
• 239000002552 dosage form Substances 0.000 claims 1
• 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
• 239000008194 pharmaceutical composition Substances 0.000 claims 1
• 238000003571 reporter gene assay Methods 0.000 claims 1
• 229930006000 Sucrose Natural products 0.000 description 3
• 239000005720 sucrose Substances 0.000 description 3
• 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 description 2
• 239000003795 chemical substances by application Substances 0.000 description 2
• 125000000185 sucrose group Chemical group 0.000 description 2
• HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
• KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
• FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
• FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
• 108010002352 Interleukin-1 Proteins 0.000 description 1
• ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 description 1
• HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 1
• CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
• HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products 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 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 1
• HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound 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 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 1
• 229960003589 arginine hydrochloride Drugs 0.000 description 1
• 201000010099 disease Diseases 0.000 description 1
• 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
• 238000004108 freeze drying Methods 0.000 description 1
• 230000001404 mediated effect Effects 0.000 description 1
• 238000000034 method Methods 0.000 description 1
• 239000008057 potassium phosphate buffer Substances 0.000 description 1
• 229910000162 sodium phosphate Inorganic materials 0.000 description 1
• 239000012064 sodium phosphate buffer Substances 0.000 description 1
• 229940074404 sodium succinate Drugs 0.000 description 1
• ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical compound [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 description 1
• 239000002904 solvent Substances 0.000 description 1
• 239000000600 sorbitol Substances 0.000 description 1
• RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1