JP2012533540A5 - - Google Patents

Info

Publication number

JP2012533540A5

JP2012533540A5 JP2012520598A JP2012520598A JP2012533540A5 JP 2012533540 A5 JP2012533540 A5 JP 2012533540A5 JP 2012520598 A JP2012520598 A JP 2012520598A JP 2012520598 A JP2012520598 A JP 2012520598A JP 2012533540 A5 JP2012533540 A5 JP 2012533540A5

Authority

JP

Japan

Prior art keywords

injection

glatiramer acetate

aqueous pharmaceutical

mannitol

outer shell

Prior art date

2010-07-14

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
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• 238000002347 injection Methods 0.000 claims description 98
• 239000007924 injection Substances 0.000 claims description 98
• 238000000034 method Methods 0.000 claims description 60
• 239000003186 pharmaceutical solution Substances 0.000 claims description 40
• 238000010254 subcutaneous injection Methods 0.000 claims description 40
• 239000007929 subcutaneous injection Substances 0.000 claims description 40
• 108010072051 Glatiramer Acetate Proteins 0.000 claims description 39
• FHEAIOHRHQGZPC-KIWGSFCNSA-N acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound CC(O)=O.C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 FHEAIOHRHQGZPC-KIWGSFCNSA-N 0.000 claims description 38
• 229960003776 glatiramer acetate Drugs 0.000 claims description 38
• 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 31
• 229930195725 Mannitol Natural products 0.000 claims description 31
• 235000010355 mannitol Nutrition 0.000 claims description 31
• 239000000594 mannitol Substances 0.000 claims description 31
• 208000007400 Relapsing-Remitting Multiple Sclerosis Diseases 0.000 claims description 25
• 239000000243 solution Substances 0.000 claims description 25
• 206010022095 Injection Site reaction Diseases 0.000 claims description 22
• 201000006417 multiple sclerosis Diseases 0.000 claims description 18
• 206010051290 Central nervous system lesion Diseases 0.000 claims description 8
• 229940071643 prefilled syringe Drugs 0.000 claims description 6
• 230000003210 demyelinating effect Effects 0.000 claims description 5
• 208000003251 Pruritus Diseases 0.000 claims description 4
• 238000004146 energy storage Methods 0.000 claims description 4
• 229920001184 polypeptide Polymers 0.000 claims description 4
• 108090000765 processed proteins & peptides Proteins 0.000 claims description 4
• 102000004196 processed proteins & peptides Human genes 0.000 claims description 4
• 230000008961 swelling Effects 0.000 claims description 4
• 208000024891 symptom Diseases 0.000 claims description 4
• 230000000007 visual effect Effects 0.000 claims description 4
• QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 3
• 230000000977 initiatory effect Effects 0.000 claims description 3
• 239000007864 aqueous solution Substances 0.000 claims description 2
• 210000001217 buttock Anatomy 0.000 claims description 2
• 239000003086 colorant Substances 0.000 claims description 2
• 210000004013 groin Anatomy 0.000 claims description 2
• 210000003127 knee Anatomy 0.000 claims description 2
• 230000003902 lesion Effects 0.000 claims description 2
• 239000007788 liquid Substances 0.000 claims description 2
• 239000000463 material Substances 0.000 claims description 2
• 230000035515 penetration Effects 0.000 claims description 2
• 210000002784 stomach Anatomy 0.000 claims description 2
• 238000007920 subcutaneous administration Methods 0.000 claims description 2
• 210000000689 upper leg Anatomy 0.000 claims description 2
• 239000008194 pharmaceutical composition Substances 0.000 claims 2
• YLOCGHYTXIINAI-XKUOMLDTSA-N (2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 YLOCGHYTXIINAI-XKUOMLDTSA-N 0.000 claims 1
• 208000016192 Demyelinating disease Diseases 0.000 claims 1
• 206010012305 Demyelination Diseases 0.000 claims 1
• 208000034189 Sclerosis Diseases 0.000 claims 1
• 238000002425 crystallisation Methods 0.000 claims 1
• 230000008025 crystallization Effects 0.000 claims 1
• 229940042385 glatiramer Drugs 0.000 claims 1
• 239000000203 mixture Substances 0.000 description 9
• 238000009472 formulation Methods 0.000 description 8
• 230000002354 daily effect Effects 0.000 description 5
• 230000003247 decreasing effect Effects 0.000 description 2
• 230000003111 delayed effect Effects 0.000 description 2
• 230000003203 everyday effect Effects 0.000 description 2
• 230000002411 adverse Effects 0.000 description 1
• 238000007906 compression Methods 0.000 description 1
• 230000006835 compression Effects 0.000 description 1
• 230000007423 decrease Effects 0.000 description 1
• 238000005259 measurement Methods 0.000 description 1
• 230000002441 reversible effect Effects 0.000 description 1
• 210000001113 umbilicus Anatomy 0.000 description 1