JP2009516700A - 低減された非毒素タンパク質を含むボツリヌス毒素の局所適用及び経皮送達のための組成物及び方法 - Google Patents
低減された非毒素タンパク質を含むボツリヌス毒素の局所適用及び経皮送達のための組成物及び方法 Download PDFInfo
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- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/99—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
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- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- 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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- A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
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- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/10—Anti-acne agents
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
- A61Q19/08—Anti-ageing preparations
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
Description
Inlander, Skin, New York:People's Medical Society, 1-7(1998) Benedetto, International Journal of Dermatology, 38:641-655(1999) Stegman et al., The Skin of the Aging Face Cosmetic Dermatological Surgery, 2nd ed., St.Louis, MO:Mosby Year Book:5-15(1990) Schantz and Scott, In Lewis GE(Ed) Biomedical Aspects of Botulinum, New York:Academic Press, 143-150(1981) Scott, Opthalmol, 87:1044-1049(1980)
本実験は、単回投与後の、無処置の皮膚を介して、無処置の標識化タンパク質であるボツリヌス毒素を含有する大きな複合体を輸送するためのシアロタンパク質の使用を実証する。
処置剤を適用する間、動物をイソフルランの吸入による麻酔下に置く。麻酔後、C57/BLK/6マウス(n=10)に、計量した200マイクロリットルの用量の、背側背部の皮膚の頭部(マウスの口又は肢は、この領域には届かないことから選んだ)に適用するのに適切な処置剤を、局所適用する。マウスには、脱毛術を施さない。初期処置30分後、CO2の吸入により、マウスを安楽死させ、処置した皮膚区域を、完全な厚さで、盲検の観察者(blinded observers)が収集する。処置区域を、3等分し、頭部を10%中性緩衝ホルマリン中で、12〜16時間固定し、次いで、パラフィン包埋まで70%エタノール中で保存する。中心部を急速冷凍し、以下に概要を述べるように、盲検の観察者によるビオチン可視化に直接利用する。処置した尾側の区域は、可溶化の研究用に急速冷凍する。
女性は、上唇の左側から扇形に広がる細い線を減らすことを望んでいる。1単位のボツリヌス毒素A型、0.01mgのシアロタンパク質を含有し、非毒素タンパク質及びアルブミンを本質的に含有しない組成物を含む経皮パッチを、細い線を含む顔面の領域に適用する。該パッチは、対象が眠っている夜間だけ適用される。1〜7日内に細い線の出現は著しく減少する。この有益な効果は、パッチの連続した適用と共に持続する。動物由来のアルブミン又はゼラチンを欠くことの結果としての低減された抗原性は、ボツリヌス毒素組成物の反復使用を可能にする。
Claims (10)
- ボツリヌス毒素複合体又は低減されたボツリヌス毒素複合体と、接着分子とを含むボツリヌス毒素を経皮送達するための組成物であって、該接着分子が、該ボツリヌス毒素複合体又は低減されたボツリヌス毒素複合体と複合体を形成する組成物。
- 外来性安定剤をさらに含む、請求項1に記載の組成物。
- 接着分子とボツリヌス毒素複合体又は低減されたボツリヌス毒素複合体との間で形成される複合体が、非共有結合性である、請求項1に記載の組成物。
- 接着分子が、シアロタンパク質である、請求項1〜3のいずれかに記載の組成物。
- 低減されたボツリヌス毒素複合体が、ボツリヌス菌(Clostridium botulinum)から直接的に抽出されるボツリヌス毒素複合体中に天然に存在する量と比較して、低減された量の赤血球凝集素タンパク質及び/又は非毒素非赤血球凝集素タンパク質を含む、請求項4に記載の組成物。
- 外来性安定剤が、アルブミンである、請求項2に記載の組成物。
- アルブミンが、天然に存在するボツリヌス毒素複合体中のアルブミン量の約500、400、300、200、100、50、10、5、1、0.5、0.1、又は0.01倍に等しい量で存在する、請求項6に記載の組成物。
- ボツリヌス毒素複合体又は低減されたボツリヌス毒素複合体が、ボツリヌス毒素誘導体、組換えボツリヌス毒素、改変されたボツリヌス毒素、ボツリヌス毒素A型、ボツリヌス毒素B型、ボツリヌス毒素C型、ボツリヌス毒素D型、ボツリヌス毒素E型、ボツリヌス毒素F型、及びボツリヌス毒素G型からなる群から選択されるボツリヌス毒素を含む、請求項1に記載の組成物。
- 請求項1に記載の組成物を局所的に適用することを含む、対象に対するボツリヌス毒素の投与方法。
- 組成物が、顔、腋窩、手掌、手、足、背中下部、頚部、脚部、鼠蹊部、腕、肘、膝、骨盤、臀部、及び胴部からなる群から選択される対象の身体の領域に適用される、請求項9に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US73814405P | 2005-11-17 | 2005-11-17 | |
US60/738,144 | 2005-11-17 | ||
PCT/US2006/060979 WO2007059528A2 (en) | 2005-11-17 | 2006-11-16 | Compositions and methods of topical application and transdermal delivery of botulinum toxins with reduced non-toxin proteins |
Publications (2)
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JP2009516700A true JP2009516700A (ja) | 2009-04-23 |
JP4944896B2 JP4944896B2 (ja) | 2012-06-06 |
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JP2008541478A Expired - Fee Related JP4944896B2 (ja) | 2005-11-17 | 2006-11-16 | 低減された非毒素タンパク質を含むボツリヌス毒素の局所適用及び経皮送達のための組成物及び方法 |
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US (2) | US8568740B2 (ja) |
EP (1) | EP1948230A4 (ja) |
JP (1) | JP4944896B2 (ja) |
KR (1) | KR101423272B1 (ja) |
CN (2) | CN101355962A (ja) |
AU (1) | AU2006315117A1 (ja) |
BR (1) | BRPI0618753A2 (ja) |
CA (1) | CA2629499A1 (ja) |
IL (1) | IL191378A (ja) |
NZ (1) | NZ568216A (ja) |
WO (1) | WO2007059528A2 (ja) |
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KR101423272B1 (ko) | 2014-07-30 |
US20070116724A1 (en) | 2007-05-24 |
CN101355962A (zh) | 2009-01-28 |
CN103126971A (zh) | 2013-06-05 |
JP4944896B2 (ja) | 2012-06-06 |
BRPI0618753A2 (pt) | 2011-09-13 |
CA2629499A1 (en) | 2007-05-24 |
EP1948230A4 (en) | 2010-03-10 |
US20090163412A1 (en) | 2009-06-25 |
IL191378A (en) | 2014-01-30 |
WO2007059528A2 (en) | 2007-05-24 |
US8518414B2 (en) | 2013-08-27 |
NZ568216A (en) | 2012-09-28 |
EP1948230A2 (en) | 2008-07-30 |
AU2006315117A1 (en) | 2007-05-24 |
US8568740B2 (en) | 2013-10-29 |
WO2007059528A3 (en) | 2007-11-08 |
KR20080072717A (ko) | 2008-08-06 |
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