JP2007332155A5 - - Google Patents
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- Publication number
- JP2007332155A5 JP2007332155A5 JP2007211802A JP2007211802A JP2007332155A5 JP 2007332155 A5 JP2007332155 A5 JP 2007332155A5 JP 2007211802 A JP2007211802 A JP 2007211802A JP 2007211802 A JP2007211802 A JP 2007211802A JP 2007332155 A5 JP2007332155 A5 JP 2007332155A5
- Authority
- JP
- Japan
- Prior art keywords
- polysaccharide
- botulinum toxin
- pharmaceutical composition
- neurotoxin
- clostridial neurotoxin
- Prior art date
- 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.)
- Granted
Links
- 150000004676 glycans Polymers 0.000 claims 9
- 229920001282 polysaccharide Polymers 0.000 claims 9
- 239000005017 polysaccharide Substances 0.000 claims 9
- 150000004804 polysaccharides Polymers 0.000 claims 9
- 231100000618 Neurotoxin Toxicity 0.000 claims 7
- 108020003835 TX1 Proteins 0.000 claims 7
- 239000002581 neurotoxin Substances 0.000 claims 7
- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- 108010043024 Botulinum Toxins Proteins 0.000 claims 5
- 229940053031 botulinum toxin Drugs 0.000 claims 5
- 241001112695 Clostridiales Species 0.000 claims 4
- DNZMDASEFMLYBU-RNBXVSKKSA-N Hydroxyethyl starch Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@@H]1O.OCCOC[C@H]1O[C@H](OCCO)[C@H](OCCO)[C@@H](OCCO)[C@@H]1OCCO DNZMDASEFMLYBU-RNBXVSKKSA-N 0.000 claims 3
- 150000001413 amino acids Chemical class 0.000 claims 3
- 229940094657 Botulinum Toxin Type A Drugs 0.000 claims 2
- 108010057266 Type A Botulinum Toxins Proteins 0.000 claims 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 230000000087 stabilizing Effects 0.000 claims 2
- 102100001249 ALB Human genes 0.000 claims 1
- 101710027066 ALB Proteins 0.000 claims 1
- 239000004475 Arginine Substances 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims 1
- 239000004472 Lysine Substances 0.000 claims 1
- 229940071643 Prefilled Syringe Drugs 0.000 claims 1
- 238000004220 aggregation Methods 0.000 claims 1
- 230000002776 aggregation Effects 0.000 claims 1
- 229940050528 albumin Drugs 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 230000036425 denaturation Effects 0.000 claims 1
- 238000004925 denaturation Methods 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 230000000699 topical Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Claims (6)
- クロストリジウム神経毒を変性または凝集に対して安定化する方法であって、クロストリジウム神経毒と多糖含有安定化組成物とを接触させる段階を含んで成り、前記接触段階が、クロストリジウム神経毒を含有する水溶液または凍結乾燥もしくは減圧乾燥粉末に、有効量の多糖を加える段階を含んで成り、但し、クロストリジウム神経毒がA型ボツリヌス毒素である場合は多糖は2−ヒドロキシエチルデンプンではない方法。
- (a)神経毒、および
(b)多糖
を含有し、該多糖が該神経毒を安定化する、再構成時または注射時のpHが約5〜7.3である医薬組成物であって、該神経毒がA型ボツリヌス毒素である場合は多糖は2−ヒドロキシエチルデンプンではない医薬組成物。 - 2つのチャンバーを有する予め充填されたシリンジから成り、シリンジの一方のチャンバーはボツリヌス毒素を含有し、シリンジの第2のチャンバーは希釈剤または緩衝剤を含有する、医薬組成物を注射するための装置。
- ボツリヌス毒素、多糖およびアミノ酸を含有し、但し、ボツリヌス毒素がA型ボツリヌス毒素である場合は多糖は2−ヒドロキシエチルデンプンではない局所投与用の医薬組成物。
- (a)ボツリヌス毒素、および
(c)アミノ酸
を実質的に含有し、アルブミンを含有せず、多糖を含有せず、−5℃で1年間貯蔵した場合、塩類液または水で再構成した際の効力が少なくとも約90%であり、再構成後2℃で72時間貯蔵後の効力が約80%である安定な医薬組成物。 - アミノ酸を、リジン、グリシン、ヒスチジンおよびアルギニンから成る群から選択する請求項4または5に記載の医薬組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US50014700A | 2000-02-08 | 2000-02-08 | |
US09/500,147 | 2000-02-08 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2004084590A Division JP4118830B2 (ja) | 2000-02-08 | 2004-03-23 | ボツリヌス毒素医薬組成物 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011160451A Division JP2011251988A (ja) | 2000-02-08 | 2011-07-22 | ボツリヌス毒素医薬組成物 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2007332155A JP2007332155A (ja) | 2007-12-27 |
JP2007332155A5 true JP2007332155A5 (ja) | 2008-04-17 |
JP5080902B2 JP5080902B2 (ja) | 2012-11-21 |
Family
ID=23988236
Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001557580A Pending JP2003522154A (ja) | 2000-02-08 | 2001-02-05 | ボツリヌス毒素医薬組成物 |
JP2004084590A Expired - Lifetime JP4118830B2 (ja) | 2000-02-08 | 2004-03-23 | ボツリヌス毒素医薬組成物 |
JP2005079801A Pending JP2005179375A (ja) | 2000-02-08 | 2005-03-18 | ボツリヌス毒素医薬組成物 |
JP2005196335A Withdrawn JP2005336201A (ja) | 2000-02-08 | 2005-07-05 | ボツリヌス毒素医薬組成物 |
JP2007211802A Expired - Lifetime JP5080902B2 (ja) | 2000-02-08 | 2007-08-15 | ボツリヌス毒素医薬組成物 |
JP2011160451A Pending JP2011251988A (ja) | 2000-02-08 | 2011-07-22 | ボツリヌス毒素医薬組成物 |
JP2011233808A Pending JP2012031194A (ja) | 2000-02-08 | 2011-10-25 | ボツリヌス毒素医薬組成物 |
Family Applications Before (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001557580A Pending JP2003522154A (ja) | 2000-02-08 | 2001-02-05 | ボツリヌス毒素医薬組成物 |
JP2004084590A Expired - Lifetime JP4118830B2 (ja) | 2000-02-08 | 2004-03-23 | ボツリヌス毒素医薬組成物 |
JP2005079801A Pending JP2005179375A (ja) | 2000-02-08 | 2005-03-18 | ボツリヌス毒素医薬組成物 |
JP2005196335A Withdrawn JP2005336201A (ja) | 2000-02-08 | 2005-07-05 | ボツリヌス毒素医薬組成物 |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011160451A Pending JP2011251988A (ja) | 2000-02-08 | 2011-07-22 | ボツリヌス毒素医薬組成物 |
JP2011233808A Pending JP2012031194A (ja) | 2000-02-08 | 2011-10-25 | ボツリヌス毒素医薬組成物 |
Country Status (19)
Country | Link |
---|---|
US (2) | US20020064536A1 (ja) |
EP (4) | EP1514556B1 (ja) |
JP (7) | JP2003522154A (ja) |
KR (3) | KR100753765B1 (ja) |
CN (2) | CN1331532C (ja) |
AR (1) | AR027391A1 (ja) |
AT (2) | ATE293988T1 (ja) |
AU (2) | AU3331501A (ja) |
BR (1) | BR0108173A (ja) |
CA (3) | CA2400318C (ja) |
CY (1) | CY1108007T1 (ja) |
DE (2) | DE60110372T2 (ja) |
DK (3) | DK1514556T3 (ja) |
ES (3) | ES2368061T3 (ja) |
MX (1) | MXPA02007519A (ja) |
NZ (2) | NZ520201A (ja) |
PT (3) | PT1398038E (ja) |
TW (2) | TWI317283B (ja) |
WO (1) | WO2001058472A2 (ja) |
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