JP2022510007A - 大型薬物の送達改善 - Google Patents

大型薬物の送達改善 Download PDF

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Publication number
JP2022510007A
JP2022510007A JP2021531637A JP2021531637A JP2022510007A JP 2022510007 A JP2022510007 A JP 2022510007A JP 2021531637 A JP2021531637 A JP 2021531637A JP 2021531637 A JP2021531637 A JP 2021531637A JP 2022510007 A JP2022510007 A JP 2022510007A
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Prior art keywords
microneedle
skin
site
composition
microneedles
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JP2021531637A
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English (en)
Japanese (ja)
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JPWO2020117564A5 (enExample
Inventor
エデルソン，ジョナサン
Original Assignee
エイリオン セラピューティクス， インコーポレイテッド
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Publication of JP2022510007A publication Critical patent/JP2022510007A/ja
Publication of JPWO2020117564A5 publication Critical patent/JPWO2020117564A5/ja
Priority to JP2024153896A priority Critical patent/JP2024170568A/ja
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/66—Enzymes
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0204—Specific forms not provided for by any of groups A61K8/0208 - A61K8/14
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/06—Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6489—Metalloendopeptidases (3.4.24)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/91—Injection
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24069—Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Dermatology (AREA)
  • Birds (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2021531637A 2018-12-03 2019-11-26 大型薬物の送達改善 Pending JP2022510007A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024153896A JP2024170568A (ja) 2018-12-03 2024-09-06 大型薬物の送達改善

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201862774677P 2018-12-03 2018-12-03
US62/774,677 2018-12-03
US201962789407P 2019-01-07 2019-01-07
US62/789,407 2019-01-07
US201962808274P 2019-02-20 2019-02-20
US62/808,274 2019-02-20
PCT/US2019/063351 WO2020117564A1 (en) 2018-12-03 2019-11-26 Improved delivery of large agents

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024153896A Division JP2024170568A (ja) 2018-12-03 2024-09-06 大型薬物の送達改善

Publications (2)

Publication Number Publication Date
JP2022510007A true JP2022510007A (ja) 2022-01-25
JPWO2020117564A5 JPWO2020117564A5 (enExample) 2022-12-05

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JP2021531637A Pending JP2022510007A (ja) 2018-12-03 2019-11-26 大型薬物の送達改善
JP2024153896A Pending JP2024170568A (ja) 2018-12-03 2024-09-06 大型薬物の送達改善

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JP2024153896A Pending JP2024170568A (ja) 2018-12-03 2024-09-06 大型薬物の送達改善

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Country Link
US (1) US20220031595A1 (enExample)
EP (1) EP3890704A1 (enExample)
JP (2) JP2022510007A (enExample)
KR (1) KR20210102301A (enExample)
CN (2) CN119700637A (enExample)
AU (2) AU2019391791A1 (enExample)
BR (2) BR122023023068A2 (enExample)
CA (1) CA3119043A1 (enExample)
IL (1) IL283627A (enExample)
MX (2) MX2021006102A (enExample)
SG (1) SG11202104838SA (enExample)
WO (1) WO2020117564A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102487144B1 (ko) 2016-11-21 2023-01-12 에이리온 테라퓨틱스, 인코포레이티드 큰 물질의 경피 전달
US12280096B2 (en) 2021-07-12 2025-04-22 Penland Foundation Treatments of cancer using nitrous oxide and botulinum toxin
KR20230024669A (ko) * 2021-08-12 2023-02-21 주식회사 페로카 마이크로니들 패치
CN114191376B (zh) * 2022-01-05 2024-03-01 中国药科大学 一种用于治疗阿尔兹海默症的微针贴片及其制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009527275A (ja) * 2006-02-17 2009-07-30 ゾゲニクス インコーポレーティッド 神経毒の送達のための方法およびシステム
WO2010056922A2 (en) * 2008-11-12 2010-05-20 Kythera Biopharmaceuticals, Inc. Systems and methods for delivery of biologically active agents
US20170209553A1 (en) * 2016-01-22 2017-07-27 Transderm, Inc. Delivery of botulinum with microneedle arrays
WO2018093465A1 (en) * 2016-11-21 2018-05-24 Eirion Therapeutics, Inc. Transdermal delivery of large agents

Family Cites Families (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US296006A (en) 1884-04-01 John hoefleb
US4270537A (en) 1979-11-19 1981-06-02 Romaine Richard A Automatic hypodermic syringe
CA1283827C (en) 1986-12-18 1991-05-07 Giorgio Cirelli Appliance for injection of liquid formulations
GB8704027D0 (en) 1987-02-20 1987-03-25 Owen Mumford Ltd Syringe needle combination
FR2638359A1 (fr) 1988-11-03 1990-05-04 Tino Dalto Guide de seringue avec reglage de la profondeur de penetration de l'aiguille dans la peau
US5008110A (en) 1988-11-10 1991-04-16 The Procter & Gamble Company Storage-stable transdermal patch
US5190521A (en) 1990-08-22 1993-03-02 Tecnol Medical Products, Inc. Apparatus and method for raising a skin wheal and anesthetizing skin
US5527288A (en) 1990-12-13 1996-06-18 Elan Medical Technologies Limited Intradermal drug delivery device and method for intradermal delivery of drugs
SE9102652D0 (sv) 1991-09-13 1991-09-13 Kabi Pharmacia Ab Injection needle arrangement
US7384918B2 (en) 1991-09-24 2008-06-10 Allergan, Inc. Botulinum toxin for treating muscle contracture
US6939852B2 (en) 1991-09-24 2005-09-06 Allergan, Inc. Methods and compositions for the treatment of cerebral palsy
US5328483A (en) 1992-02-27 1994-07-12 Jacoby Richard M Intradermal injection device with medication and needle guard
US6010715A (en) 1992-04-01 2000-01-04 Bertek, Inc. Transdermal patch incorporating a polymer film incorporated with an active agent
US5591767A (en) 1993-01-25 1997-01-07 Pharmetrix Corporation Liquid reservoir transdermal patch for the administration of ketorolac
IT1261849B (it) 1993-09-02 1996-06-03 Avantgarde Spa Dispositivo medico per la somministrazione di principi attivi o farmaci a bassissimo dosaggio, in particolare di farmaci omeopatici.
US5512547A (en) 1994-10-13 1996-04-30 Wisconsin Alumni Research Foundation Pharmaceutical composition of botulinum neurotoxin and method of preparation
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
US5948433A (en) 1997-08-21 1999-09-07 Bertek, Inc. Transdermal patch
IT1298087B1 (it) 1998-01-08 1999-12-20 Fiderm S R L Dispositivo per il controllo della profondita' di penetrazione di un ago, in particolare applicabile ad una siringa per iniezioni
US5965154A (en) 1998-03-17 1999-10-12 Plc Holding, L.L.C. Adhesive matrix type transdermal patch and method of manufacturing same
US6503231B1 (en) 1998-06-10 2003-01-07 Georgia Tech Research Corporation Microneedle device for transport of molecules across tissue
US6611707B1 (en) 1999-06-04 2003-08-26 Georgia Tech Research Corporation Microneedle drug delivery device
US6306423B1 (en) 2000-06-02 2001-10-23 Allergan Sales, Inc. Neurotoxin implant
US6908453B2 (en) 2002-01-15 2005-06-21 3M Innovative Properties Company Microneedle devices and methods of manufacture
US20040009180A1 (en) 2002-07-11 2004-01-15 Allergan, Inc. Transdermal botulinum toxin compositions
CN101160318A (zh) 2005-03-03 2008-04-09 雷文斯治疗公司 用于局部施用和经皮肤递送寡肽的组合物和方法
US8658391B2 (en) 2006-04-27 2014-02-25 Anterios, Inc. Assessment of the effects of topical administration of chemodenervating pharmaceuticals
US20120150023A1 (en) 2007-08-06 2012-06-14 Kaspar Roger L Microneedle arrays for active agent delivery
MX379265B (es) * 2008-06-26 2025-03-11 Anterios Inc Aplicacion dérmica de toxina botulínica en nanoemulsiones para usarse en el tratamiento de trastornos de la piel.
KR20190064676A (ko) * 2008-11-18 2019-06-10 쓰리엠 이노베이티브 프로퍼티즈 컴파니 중공 마이크로니들 어레이
HUE037595T2 (hu) 2008-12-31 2018-09-28 Revance Therapeutics Inc Injektálható botulinum toxin készítmények
EP2575872B1 (en) * 2010-06-01 2020-08-19 Seqirus UK Limited Concentration of influenza vaccine antigens without lyophilization
IL293156A (en) 2011-01-24 2022-07-01 Anterios Inc Nanoparticle compounds, their formulations, and their use
WO2012103035A1 (en) 2011-01-24 2012-08-02 Anterios, Inc. Nanoparticle compositions
WO2013096026A1 (en) 2011-12-21 2013-06-27 3M Innovative Properties Company Transdermal adhesive patch assembly with removable microneedle array and method of using same
EP3068423A1 (en) * 2013-11-12 2016-09-21 Finzi, Eric Treatment of social anxiety disorder, obsessive compulsive disorder and panic disorder using botulinum toxin
JP2019523302A (ja) * 2016-07-29 2019-08-22 エル． カスパー、ロジャー 腋臭を治療する方法
CN107320841A (zh) * 2017-08-03 2017-11-07 党明 一种高分子微针及其制备方法和应用

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009527275A (ja) * 2006-02-17 2009-07-30 ゾゲニクス インコーポレーティッド 神経毒の送達のための方法およびシステム
WO2010056922A2 (en) * 2008-11-12 2010-05-20 Kythera Biopharmaceuticals, Inc. Systems and methods for delivery of biologically active agents
US20170209553A1 (en) * 2016-01-22 2017-07-27 Transderm, Inc. Delivery of botulinum with microneedle arrays
WO2018093465A1 (en) * 2016-11-21 2018-05-24 Eirion Therapeutics, Inc. Transdermal delivery of large agents

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, vol. 69, JPN6023035051, 2008, pages 1040 - 1045, ISSN: 0005139088 *
INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 391, JPN6023035052, 2010, pages 7 - 12, ISSN: 0005139089 *
JOURNAL OF CONTROLLED RELEASE, vol. 154, JPN6023035050, 2011, pages 148 - 155, ISSN: 0005455274 *

Also Published As

Publication number Publication date
BR112021009554A2 (pt) 2021-08-17
WO2020117564A1 (en) 2020-06-11
MX2025005302A (es) 2025-06-02
CA3119043A1 (en) 2020-06-11
AU2025226856A1 (en) 2025-10-23
CN119700637A (zh) 2025-03-28
AU2019391791A1 (en) 2021-06-03
MX2021006102A (es) 2021-09-21
SG11202104838SA (en) 2021-06-29
KR20210102301A (ko) 2021-08-19
US20220031595A1 (en) 2022-02-03
BR122023023068A2 (pt) 2024-02-20
JP2024170568A (ja) 2024-12-10
IL283627A (en) 2021-07-29
CN113423381A (zh) 2021-09-21
EP3890704A1 (en) 2021-10-13

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