CN1316906A - 稳定的肉毒毒素液体制剂 - Google Patents
稳定的肉毒毒素液体制剂 Download PDFInfo
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- CN1316906A CN1316906A CN99810739A CN99810739A CN1316906A CN 1316906 A CN1316906 A CN 1316906A CN 99810739 A CN99810739 A CN 99810739A CN 99810739 A CN99810739 A CN 99810739A CN 1316906 A CN1316906 A CN 1316906A
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- botulinum toxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
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- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
- A61K38/4893—Botulinum neurotoxin (3.4.24.69)
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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Abstract
Description
活性成分 | 非活性成分 | 浓度 |
肉毒毒素B型 | - | 5000±1000LD50U/mL |
- | 琥珀酸盐,USP | 10mM |
- | 氯化钠,USP | 100mM |
- | 人血清白蛋白,FDA分发 | 0.5mg/mL |
- | 盐酸,NF | 用于调节pH |
贮藏时间(月) | 效力(平均;U/ml) | pH | 外观a |
0 | 1750-3250 | 5.5 | 合格 |
1 | 1941 | NDb | ND |
3 | 2541 | 5.6 | ND |
6 | 2020 | 5.6 | 合格 |
9 | 2357 | 5.6 | 合格 |
12 | 2064 | 5.6 | 合格 |
18 | 2318 | 5.4 | 合格 |
24 | 1799 | 5.6 | 合格 |
30 | 2101 | 5.6 | 合格 |
贮藏时间(月) | 效力(平均;U/ml) | pH | 外观a |
0 | 1941 | 5.5 | 合格 |
1 | 2297 | 5.6 | NDb |
2 | 1935 | 5.6 | ND |
3 | 2017 | 5.6 | ND |
6 | 1909 | ND | 合格 |
9 | 1579 | 5.6 | 合格 |
Claims (50)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US9987098P | 1998-09-11 | 1998-09-11 | |
US60/099,870 | 1998-09-11 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1316906A true CN1316906A (zh) | 2001-10-10 |
CN100438905C CN100438905C (zh) | 2008-12-03 |
Family
ID=22277018
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB998107395A Expired - Fee Related CN100438905C (zh) | 1998-09-11 | 1999-09-09 | 稳定的肉毒毒素液体制剂 |
Country Status (41)
Country | Link |
---|---|
US (2) | US7211261B1 (zh) |
EP (1) | EP1112082B2 (zh) |
JP (4) | JP4557426B2 (zh) |
KR (1) | KR100699756B1 (zh) |
CN (1) | CN100438905C (zh) |
AP (1) | AP1591A (zh) |
AR (1) | AR022671A1 (zh) |
AT (1) | ATE221386T1 (zh) |
AU (1) | AU755556C (zh) |
BG (1) | BG65555B1 (zh) |
BR (1) | BR9913585A (zh) |
CA (1) | CA2342243C (zh) |
CO (1) | CO5170497A1 (zh) |
CU (1) | CU23251A3 (zh) |
DE (1) | DE69902396T3 (zh) |
DK (1) | DK1112082T4 (zh) |
EA (1) | EA003367B1 (zh) |
EE (1) | EE200100140A (zh) |
ES (1) | ES2181473T5 (zh) |
GE (1) | GEP20032946B (zh) |
HK (1) | HK1040927A1 (zh) |
HR (1) | HRP20010259B1 (zh) |
HU (1) | HUP0103638A3 (zh) |
ID (1) | ID28824A (zh) |
IL (2) | IL141564A0 (zh) |
IS (1) | IS2381B (zh) |
LT (1) | LT4959B (zh) |
LV (1) | LV12684B (zh) |
NO (1) | NO328898B1 (zh) |
NZ (1) | NZ509349A (zh) |
PL (1) | PL200926B1 (zh) |
PT (1) | PT1112082E (zh) |
RS (1) | RS50344B (zh) |
SA (1) | SA99200566B1 (zh) |
SI (2) | SI20566B (zh) |
SK (1) | SK286919B6 (zh) |
TR (1) | TR200100728T2 (zh) |
TW (1) | TW574036B (zh) |
UA (1) | UA72477C2 (zh) |
WO (1) | WO2000015245A2 (zh) |
ZA (1) | ZA200101709B (zh) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106924216A (zh) * | 2011-01-24 | 2017-07-07 | 安特里奥公司 | 纳米颗粒组合物、其制剂和它们的用途 |
CN107206175A (zh) * | 2015-02-03 | 2017-09-26 | 莫茨制药有限及两合公司 | 肉毒杆菌毒素预填充式容器 |
CN107205889A (zh) * | 2014-09-02 | 2017-09-26 | 美国白银有限责任公司 | 肉毒毒素和胶体银颗粒 |
CN107789620A (zh) * | 2009-04-17 | 2018-03-13 | 德国麦氏大药厂 | 用于稳定蛋白的不含哺乳动物赋形剂的制剂 |
US11311496B2 (en) | 2016-11-21 | 2022-04-26 | Eirion Therapeutics, Inc. | Transdermal delivery of large agents |
Families Citing this family (73)
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JP3066079B2 (ja) * | 1994-05-09 | 2000-07-17 | ビンダー,ウィリアム,ジェイ. | 頭痛を低減する方法 |
TW574036B (en) * | 1998-09-11 | 2004-02-01 | Elan Pharm Inc | Stable liquid compositions of botulinum toxin |
US20120238504A1 (en) * | 1998-09-11 | 2012-09-20 | Solstice Neurosciences, Llc | Stable Formulations of Botulinum Toxin in Hydrogels |
DE19925739A1 (de) * | 1999-06-07 | 2000-12-21 | Biotecon Ges Fuer Biotechnologische Entwicklung & Consulting Mbh | Therapeutikum mit einem Botulinum-Neurotoxin |
US7838007B2 (en) | 1999-12-07 | 2010-11-23 | Allergan, Inc. | Methods for treating mammary gland disorders |
US7838008B2 (en) | 1999-12-07 | 2010-11-23 | Allergan, Inc. | Methods for treating diverse cancers |
EP1586329A1 (en) * | 2000-02-08 | 2005-10-19 | Allergan, Inc. | Botulinum toxin pharmaceutical compositions |
US20030118598A1 (en) | 2000-02-08 | 2003-06-26 | Allergan, Inc. | Clostridial toxin pharmaceutical compositions |
US8632785B2 (en) * | 2000-02-08 | 2014-01-21 | Allergan, Inc. | Clostridial toxin pharmaceutical composition containing a gelatin fragment |
US20060269575A1 (en) * | 2000-02-08 | 2006-11-30 | Allergan, Inc. | Botulinum toxin pharmaceutical compositions formulated with recombinant albumin |
US7780967B2 (en) | 2000-02-08 | 2010-08-24 | Allergan, Inc. | Reduced toxicity Clostridial toxin pharmaceutical compositions |
US6821520B2 (en) | 2000-02-15 | 2004-11-23 | Allergan, Inc. | Clostridial toxin therapy for Hashimoto's thyroiditis |
ITUD20010002A1 (it) | 2001-01-05 | 2002-07-05 | Univ Degli Studi Udine | Uso della tossina botulinica per la soluzione di patologie articolari, in particolare della coxartrosi, della epicondilite e della patolo |
CA2369810C (en) * | 2002-01-30 | 2007-08-07 | 1474791 Ontario Limited | Method of treating pain |
US7140371B2 (en) | 2002-03-14 | 2006-11-28 | Allergan, Inc. | Surface topography method for determining effects of a botulinum toxin upon a muscle and for comparing botulinum toxins |
US6688311B2 (en) | 2002-03-14 | 2004-02-10 | Allergan, Inc. | Method for determining effect of a clostridial toxin upon a muscle |
EP1491205A4 (en) * | 2002-03-29 | 2007-04-25 | Chemo Sero Therapeut Res Inst | MEANS FOR THE TREATMENT OF HYPERMYOTONIA |
US7691394B2 (en) * | 2002-05-28 | 2010-04-06 | Botulinum Toxin Research Associates, Inc. | High-potency botulinum toxin formulations |
US20040009180A1 (en) * | 2002-07-11 | 2004-01-15 | Allergan, Inc. | Transdermal botulinum toxin compositions |
CA2854831C (en) | 2002-11-21 | 2016-08-30 | Ira Sanders | Treatment of mammalian reaction to ige interactions |
MXPA05006690A (es) * | 2002-12-20 | 2006-02-17 | Botulinum Toxin Res Ass Inc | Composiciones farmaceuticas de toxina botulinica mejoradas. |
US8071550B2 (en) | 2003-03-03 | 2011-12-06 | Allergan, Inc. | Methods for treating uterine disorders |
MXPA05009425A (es) * | 2003-03-06 | 2006-02-10 | Botulinum Toxin Res Ass Inc | Tratamiento del dolor facial cronico y cefalea relacionados con la sinusitis con toxina botulinica. |
WO2004078200A1 (en) * | 2003-03-06 | 2004-09-16 | Botulinum Toxin Research Associates, Inc. | Selection of patients with increased responsiveness to botulinum toxin |
US6838434B2 (en) * | 2003-05-02 | 2005-01-04 | Allergan, Inc. | Methods for treating sinus headache |
US7220422B2 (en) * | 2003-05-20 | 2007-05-22 | Allergan, Inc. | Methods and compositions for treating eye disorders |
US8617572B2 (en) | 2003-10-29 | 2013-12-31 | Allergan, Inc. | Botulinum toxin treatments of depression |
US8734810B2 (en) | 2003-10-29 | 2014-05-27 | Allergan, Inc. | Botulinum toxin treatments of neurological and neuropsychiatric disorders |
US8609113B2 (en) | 2003-10-29 | 2013-12-17 | Allergan, Inc. | Botulinum toxin treatments of depression |
US8609112B2 (en) | 2003-10-29 | 2013-12-17 | Allergan, Inc. | Botulinum toxin treatments of depression |
AU2005251676B2 (en) | 2004-03-03 | 2011-09-29 | Revance Therapeutics, Inc. | Compositions and methods for topical diagnostic and therapeutic transport |
PT2656859E (pt) | 2004-03-03 | 2016-02-24 | Revance Therapeutics Inc | Aplicação tópica e administração transdérmica de toxinas botulínicas |
US9211248B2 (en) | 2004-03-03 | 2015-12-15 | Revance Therapeutics, Inc. | Compositions and methods for topical application and transdermal delivery of botulinum toxins |
KR100852822B1 (ko) | 2004-07-26 | 2008-08-18 | 메르츠 파마 게엠베하 운트 코. 카가아 | 보툴리눔 신경독소를 포함하는 치료 조성물 |
US7179474B2 (en) | 2004-09-03 | 2007-02-20 | Allergan, Inc. | Methods for treating a buttock deformity |
US7429386B2 (en) | 2004-09-03 | 2008-09-30 | Allergan, Inc. | Stretch mark treatment |
WO2006073410A1 (en) * | 2005-01-03 | 2006-07-13 | Botulinum Toxin Research Associates, Inc. | Compositions, methods and devices for preparing less painful botulinum toxin formulations |
US9180081B2 (en) | 2005-03-03 | 2015-11-10 | Revance Therapeutics, Inc. | Compositions and methods for topical application and transdermal delivery of botulinum toxins |
US7419675B2 (en) | 2005-05-26 | 2008-09-02 | Allergan, Inc. | Method for treating peritoneal adhesions |
US8323666B2 (en) | 2005-08-01 | 2012-12-04 | Allergan, Inc. | Botulinum toxin compositions |
US8137677B2 (en) | 2005-10-06 | 2012-03-20 | Allergan, Inc. | Non-protein stabilized clostridial toxin pharmaceutical compositions |
US8168206B1 (en) | 2005-10-06 | 2012-05-01 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
DE102006019447A1 (de) * | 2006-04-24 | 2007-10-25 | Dressler, Dirk, Dr. | Markierung von Botulinum Toxin |
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