CN105682650B - 用于使用非镇静性右旋美托咪啶经皮组合物治疗戒断综合征的方法和组合物 - Google Patents

用于使用非镇静性右旋美托咪啶经皮组合物治疗戒断综合征的方法和组合物 Download PDF

Info

Publication number
CN105682650B
CN105682650B CN201480058703.8A CN201480058703A CN105682650B CN 105682650 B CN105682650 B CN 105682650B CN 201480058703 A CN201480058703 A CN 201480058703A CN 105682650 B CN105682650 B CN 105682650B
Authority
CN
China
Prior art keywords
dexmedetomidine
subject
delivery device
transdermal delivery
transdermal
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.)
Active
Application number
CN201480058703.8A
Other languages
English (en)
Chinese (zh)
Other versions
CN105682650A (zh
Inventor
阿德查拉·蓬皮拉帕特
阿米特·杰恩
布雷特·伯纳
温建业
首藤十太郎
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teikoku Pharma USA Inc
Original Assignee
Teikoku Pharma USA Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Teikoku Pharma USA Inc filed Critical Teikoku Pharma USA Inc
Publication of CN105682650A publication Critical patent/CN105682650A/zh
Application granted granted Critical
Publication of CN105682650B publication Critical patent/CN105682650B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/417—Imidazole-alkylamines, e.g. histamine, phentolamine
    • 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
    • A61K47/06—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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/34—Tobacco-abuse
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Addiction (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201480058703.8A 2013-10-07 2014-10-03 用于使用非镇静性右旋美托咪啶经皮组合物治疗戒断综合征的方法和组合物 Active CN105682650B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361887871P 2013-10-07 2013-10-07
US61/887,871 2013-10-07
PCT/US2014/059058 WO2015054063A1 (en) 2013-10-07 2014-10-03 Methods and compositions for treating withdrawal syndromes using non-sedative dexmedetomidine transdermal compositions

Publications (2)

Publication Number Publication Date
CN105682650A CN105682650A (zh) 2016-06-15
CN105682650B true CN105682650B (zh) 2020-09-25

Family

ID=52777130

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201480058703.8A Active CN105682650B (zh) 2013-10-07 2014-10-03 用于使用非镇静性右旋美托咪啶经皮组合物治疗戒断综合征的方法和组合物

Country Status (11)

Country Link
US (1) US20150098983A1 (https=)
EP (1) EP3054934B1 (https=)
JP (1) JP6231670B2 (https=)
KR (2) KR20160055934A (https=)
CN (1) CN105682650B (https=)
CA (1) CA2924190C (https=)
ES (1) ES2983565T3 (https=)
FI (1) FI3054934T3 (https=)
RU (1) RU2648817C2 (https=)
TW (1) TWI624278B (https=)
WO (1) WO2015054063A1 (https=)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2924233C (en) * 2013-10-07 2018-10-23 Teikoku Pharma Usa, Inc. Methods and compositions for treating attention deficit hyperactivity disorder, anxiety and insomnia using dexmedetomidine transdermal compositions
GB201600918D0 (en) * 2016-01-18 2016-03-02 Buzzz Pharmaceuticals Ltd Transdermal patch
TWI764951B (zh) * 2016-10-31 2022-05-21 美商帝國製藥美國股份有限公司 用於處理疼痛之右美托咪啶經皮遞送裝置
KR102793584B1 (ko) 2016-12-31 2025-04-09 바이오엑셀 테라퓨틱스 인코포레이티드 불안의 치료를 위한 설하 덱스메데토미딘의 용도
CN111447927A (zh) * 2017-12-08 2020-07-24 帝国制药美国公司 纳洛酮经皮给药装置及其使用方法
PL3813802T3 (pl) 2018-06-27 2025-04-22 Bioxcel Therapeutics, Inc. Formulacje błony zawierające deksmedetomidynę i sposoby ich wytwarzania
WO2020006119A1 (en) 2018-06-27 2020-01-02 Bioxcel Therapeutics, Inc. Methods for treating agitation using dexmedetomidine hydrochloride
CA3077561A1 (en) * 2018-10-15 2020-04-15 Amnon VARDI Slow release cannabinoids and products thereof
US20220218689A1 (en) * 2018-10-24 2022-07-14 Saniona A/S Transdermal tropane compositions and methods for using the same
US20220241218A1 (en) * 2019-04-17 2022-08-04 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system
EP3999058A4 (en) * 2019-07-19 2023-05-03 Bioxcel Therapeutics, Inc. NON-SEDATIVE DEXMEDETOMIDINE-BASED TREATMENT REGIMEN
US12364692B2 (en) 2020-02-14 2025-07-22 Teikoku Pharma Usa, Inc. Topical naloxone compositions and methods for using the same
EP4225305A4 (en) * 2020-10-08 2024-10-23 Bioxcel Therapeutics, Inc. TREATMENT OF BIPOLAR DISEASES AND PSYCHOSES WITH DEXMEDETOMIDINE HYDROCHLORIDE
WO2022147537A1 (en) * 2021-01-04 2022-07-07 Bioxcel Therapeutics, Inc. Dexmedetomidine treatment regimens
CN115227638B (zh) * 2022-07-19 2025-03-18 广州新济生物医药研究院有限公司 一种盐酸右美托咪定可溶性微针及其制备方法
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
AU2024253436A1 (en) * 2023-04-04 2025-11-13 Board Of Regents, The University Of Texas System Combinations including methocinnamox

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1035922C (zh) * 1989-08-18 1997-09-24 天鹅探究有限公司 经皮肤使用的右旋美托咪定系统的制备方法
US6071531A (en) * 1995-06-07 2000-06-06 Ortho-Mcneil Pharmaceutical, Inc. Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen
US20090258063A1 (en) * 2006-09-11 2009-10-15 Sekisui Chemical Co., Ltd. Transdermal patch
US8242158B1 (en) * 2012-01-04 2012-08-14 Hospira, Inc. Dexmedetomidine premix formulation

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5217718A (en) * 1989-08-18 1993-06-08 Cygnus Therapeutic Systems Method and device for administering dexmedetomidine transdermally
GB9111732D0 (en) * 1991-05-31 1991-07-24 Orion Yhtymae Oy The use of certain salts of medetomidine and its optically active enantiomers to regulate the rate of transdermal administration of the drugs
GB9521680D0 (en) * 1995-10-23 1996-01-03 Orion Yhtymo Oy New use of imidazole derivatives
US5891868A (en) * 1997-11-21 1999-04-06 Kaiser Foundation Health Plan, Inc. Methods for treating postmenopausal women using ultra-low doses of estrogen
NZ510771A (en) * 1998-10-02 2003-08-29 3M Innovative Properties Co Mucosal originated drug delivery systems
US20030170195A1 (en) * 2000-01-10 2003-09-11 Noven Pharmaceuticals, Inc. Compositions and methods for drug delivery
JP4694967B2 (ja) * 2003-07-31 2011-06-08 久光製薬株式会社 貼付剤
JP5547065B2 (ja) * 2008-05-15 2014-07-09 久光製薬株式会社 パロノセトロンを含有する経皮吸収製剤
AU2011204315A1 (en) * 2010-01-08 2012-08-02 Recro Pharma, Inc. Topical transdermal dexmedetomidine compositions and methods of use thereof
CN103200944B (zh) * 2010-11-17 2016-05-04 赫克萨尔股份公司 包含丁丙诺啡的经皮治疗系统
WO2013072763A2 (en) * 2011-11-16 2013-05-23 Nometics Inc. Non-sensitizing transdermal clonidine patch
AU2012352528B9 (en) * 2011-12-11 2017-11-02 Baudax Bio, Inc. Intranasal dexmedetomidine compositions and methods of use thereof
US20130211351A1 (en) * 2012-01-31 2013-08-15 Gruenenthal Gmbh Pharmaceutical patch for transdermal administration of (1r,4r)-6'-fluoro-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyclohexane-1,1'-pyrano[3,4-b]indol]-4-amine

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1035922C (zh) * 1989-08-18 1997-09-24 天鹅探究有限公司 经皮肤使用的右旋美托咪定系统的制备方法
US6071531A (en) * 1995-06-07 2000-06-06 Ortho-Mcneil Pharmaceutical, Inc. Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen
US20090258063A1 (en) * 2006-09-11 2009-10-15 Sekisui Chemical Co., Ltd. Transdermal patch
US8242158B1 (en) * 2012-01-04 2012-08-14 Hospira, Inc. Dexmedetomidine premix formulation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Dexmedetomidine for opioid and benzodiazepine withdrawal in pediatric patients";Alexandra Oschman et al.;《Am J Health-Syst Pharm》;20110701;第68卷;1233-1238 *
"右美托咪定临床应用的研究进展";张瑶等;《医学综述》;20130228;第19卷(第4期);693-695 *

Also Published As

Publication number Publication date
ES2983565T3 (es) 2024-10-23
JP6231670B2 (ja) 2017-11-15
CN105682650A (zh) 2016-06-15
US20150098983A1 (en) 2015-04-09
KR101881791B1 (ko) 2018-07-25
CA2924190A1 (en) 2015-04-16
RU2648817C2 (ru) 2018-03-28
WO2015054063A1 (en) 2015-04-16
EP3054934B1 (en) 2024-05-22
BR112016006200A2 (pt) 2017-08-01
JP2016532643A (ja) 2016-10-20
TWI624278B (zh) 2018-05-21
FI3054934T3 (fi) 2024-07-19
EP3054934A1 (en) 2016-08-17
RU2016109632A (ru) 2017-11-15
KR20180021902A (ko) 2018-03-05
CA2924190C (en) 2019-07-09
EP3054934A4 (en) 2017-04-05
KR20160055934A (ko) 2016-05-18
TW201521799A (zh) 2015-06-16

Similar Documents

Publication Publication Date Title
CN105682650B (zh) 用于使用非镇静性右旋美托咪啶经皮组合物治疗戒断综合征的方法和组合物
US12527770B2 (en) Methods of managing pain using dexmedetomidine transdermal delivery devices
CA2924231C (en) Dexmedetomidine transdermal delivery devices and methods for using the same
ES2847936T3 (es) Métodos y composiciones para el suministro transdérmico de una cantidad no sedante de dexmedetomidina
EP3054935A2 (en) Methods and compositions for treating attention deficit hyperactivity disorder, anxiety and insomnia using dexmedetomidine transdermal compositions
TW201524506A (zh) 包含右美托嘧啶（ｄｅｘｍｅｄｅｔｏｍｉｄｉｎｅ）經皮組成物之疼痛處理用方法及組成物
US20190175519A1 (en) Naloxone Transdermal Delivery Devices and Methods for Using the Same
BR112016006200B1 (pt) Uso de dispositivo de distribuição transdérmica para tratar síndrome de abstinência
HK40033308A (en) Naloxone transdermal drug-delivery devices and methods for using the same
HK40018815A (en) Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant