RU2016109631A - Способы и композиции для лечения боли, включающие трансдермальные композиции на основе дексмедетомидина - Google Patents
Способы и композиции для лечения боли, включающие трансдермальные композиции на основе дексмедетомидина Download PDFInfo
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- RU2016109631A RU2016109631A RU2016109631A RU2016109631A RU2016109631A RU 2016109631 A RU2016109631 A RU 2016109631A RU 2016109631 A RU2016109631 A RU 2016109631A RU 2016109631 A RU2016109631 A RU 2016109631A RU 2016109631 A RU2016109631 A RU 2016109631A
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- Prior art keywords
- pain
- dexmedetomidine
- subject
- delivering
- sedative amount
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 16
- 208000002193 Pain Diseases 0.000 title claims 14
- HRLIOXLXPOHXTA-NSHDSACASA-N dexmedetomidine Chemical compound C1([C@@H](C)C=2C(=C(C)C=CC=2)C)=CN=C[N]1 HRLIOXLXPOHXTA-NSHDSACASA-N 0.000 title claims 12
- 229960004253 dexmedetomidine Drugs 0.000 title claims 12
- 239000000203 mixture Substances 0.000 title claims 4
- 239000000932 sedative agent Substances 0.000 claims 6
- 230000001624 sedative effect Effects 0.000 claims 6
- 208000004296 neuralgia Diseases 0.000 claims 4
- 208000021722 neuropathic pain Diseases 0.000 claims 4
- 230000037317 transdermal delivery Effects 0.000 claims 4
- 208000023890 Complex Regional Pain Syndromes Diseases 0.000 claims 1
- 208000031886 HIV Infections Diseases 0.000 claims 1
- 208000037357 HIV infectious disease Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 208000004550 Postoperative Pain Diseases 0.000 claims 1
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims 1
- 208000005298 acute pain Diseases 0.000 claims 1
- 238000004026 adhesive bonding Methods 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 208000033519 human immunodeficiency virus infectious disease Diseases 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 230000001404 mediated effect Effects 0.000 claims 1
- 239000011241 protective layer Substances 0.000 claims 1
- 210000002820 sympathetic nervous system Anatomy 0.000 claims 1
- 229920002554 vinyl polymer Polymers 0.000 claims 1
Classifications
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- 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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
-
- 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
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (21)
1. Способ лечения боли у субъекта, включающий нанесение на поверхность кожи субъекта, испытывающего боль, устройства для трансдермальной доставки, содержащего:
композицию на основе дексмедетомидина, содержащую:
дексмедетомидин; и
клей, склеивающий при надавливании; и
защитный слой,
причем композиция на основе дексмедетомидина составлена так, чтобы доставлять количество дексмедетомидина, эффективное для лечения боли у субъекта.
2. Способ по п. 1, отличающийся тем, что боль выбрана из группы, состоящей из идиопатической боли, острой боли, симпатически опосредованной боли, боли, связанной с комплексным регионарным болевым синдромом, и невропатической боли, и их комбинаций.
3. Способ по п. 2, отличающийся тем, что боль представляет собой невропатическую боль.
4. Способ по п. 3, отличающийся тем, что невропатическая боль связана с симпатической нервной системой.
5. Способ по п. 3, отличающийся тем, что невропатическая боль выбрана из группы, состоящей из боли, связанной с раковыми заболеваниями, послеоперационной боли, боли, связанной с инфекцией, боли, связанной с опоясывающим лишаем и боли, связанной с ВИЧ-инфекцией.
6. Способ по п. 1, включающий доставку субъекту неседативного количества дексмедетомидина.
7. Способ по п. 6, включающий доставку субъекту неседативного количества дексмедетомидина в течение 1 дня или более.
8. Способ по п. 7, включающий доставку субъекту неседативного количества дексмедетомидина в течение 3 дней или более.
9. Способ по п. 8, включающий доставку субъекту неседативного количества дексмедетомидина в течение 7 дней или более.
10. Способ по любому из пп. 6-9, включающий доставку субъекту неседативного количества дексмедетомидина таким образом, чтобы показатель шкалы Рамсея для субъекта составлял не более 3 баллов.
11. Способ по п. 1, включающий доставку субъекту седативного количества дексмедетомидина.
12. Способ по п. 1, включающий доставку субъекту дексмедетомидина с помощью устройства для трансдермальной доставки со скоростью, которая изменяется от около 5 мкг/сутки до около 500 мкг/сутки.
13. Способ по п. 1, отличающийся тем, что клей, склеивающий при надавливании, содержит виниловый полимер.
14. Устройство для трансдермальной доставки, выполненное с возможностью применения в способе по любому из пп. 1-13.
15. Набор, содержащий
два или более устройств для трансдермальной доставки, выполненных с возможностью применения в способе по любому из пп. 1-13.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361887870P | 2013-10-07 | 2013-10-07 | |
| US61/887,870 | 2013-10-07 | ||
| PCT/US2014/059057 WO2015054062A2 (en) | 2013-10-07 | 2014-10-03 | Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2016109631A true RU2016109631A (ru) | 2017-11-15 |
| RU2654702C2 RU2654702C2 (ru) | 2018-05-22 |
Family
ID=52777129
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2016109631A RU2654702C2 (ru) | 2013-10-07 | 2014-10-03 | Способы и композиции для лечения боли, включающие трансдермальные композиции на основе дексмедетомидина |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US20150098982A1 (ru) |
| EP (1) | EP3054931B1 (ru) |
| JP (2) | JP6188934B2 (ru) |
| KR (2) | KR101891186B1 (ru) |
| CN (2) | CN110604728A (ru) |
| CA (1) | CA2924188C (ru) |
| ES (1) | ES2855103T3 (ru) |
| RU (1) | RU2654702C2 (ru) |
| TW (1) | TWI629061B (ru) |
| WO (1) | WO2015054062A2 (ru) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101831290B1 (ko) | 2013-10-07 | 2018-02-22 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 덱스메데토미딘 경피 조성물을 사용하여 주의력 결핍 과잉행동 장애, 불안 및 불면증을 치료하기 위한 방법 및 조성물 |
| TWI704933B (zh) | 2013-10-07 | 2020-09-21 | 美商帝國製藥美國股份有限公司 | 右美托咪啶經皮輸送裝置及使用其之方法 |
| KR101891186B1 (ko) * | 2013-10-07 | 2018-08-24 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 덱스메데토미딘 경피 조성물을 포함하는 통증을 관리하기 위한 방법 및 조성물 |
| CN105764496B (zh) | 2013-10-07 | 2020-09-25 | 帝国制药美国公司 | 用于经皮递送非镇静量的右旋美托咪啶的方法和组合物 |
| KR20190060007A (ko) * | 2016-10-31 | 2019-05-31 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 덱스메데토미딘 경피 전달 장치를 이용한 통증을 관리하는 방법 |
| EP4371554A3 (en) | 2016-12-31 | 2024-08-07 | BioXcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| SG11202012772XA (en) | 2018-06-27 | 2021-01-28 | Bioxcel Therapeutics Inc | Film formulations containing dexmedetomidine and methods of producing them |
| US20220211672A1 (en) | 2019-05-01 | 2022-07-07 | Clexio Biosciences Ltd. | Methods of treating pruritus |
| US11185532B2 (en) | 2019-05-01 | 2021-11-30 | Clexio Biosciences Ltd. | Methods of treating pruritus |
| WO2021016112A2 (en) | 2019-07-19 | 2021-01-28 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| CN117582424A (zh) * | 2022-08-17 | 2024-02-23 | 宜昌人福药业有限责任公司 | 右美托咪定经皮组合物、透皮贴剂及其制备方法和应用 |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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| US5124157A (en) * | 1989-08-18 | 1992-06-23 | 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 |
| GB2290964A (en) * | 1994-07-08 | 1996-01-17 | Arto Olavi Urtti | Transdermal drug delivery system |
| UA48973C2 (ru) * | 1995-06-07 | 2002-09-16 | Орто-Макнейл Фармасьютікалз Інк. | Чрезкожный пластырь на основе 17-дезацетилированного норгестимата для предупреждения овуляции |
| CZ20011188A3 (cs) * | 1998-10-02 | 2001-08-15 | 3M Innovative Properties Company | Prostředky pro slizniční podání léčiv a jejich použití u zvířat |
| US7635488B2 (en) * | 2001-03-13 | 2009-12-22 | Dbv Technologies | Patches and uses thereof |
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| US9308203B2 (en) * | 2008-10-01 | 2016-04-12 | Taiwan Biotech Co., Ltd. | Pressure sensitive adhesive matrix device or system for the treatment or prevention of onychomycosis or tinea pedis |
| NZ703808A (en) * | 2010-01-08 | 2016-01-29 | Recro Pharma Inc | Topical transdermal dexmedetomidine compositions and methods of use thereof |
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| DK2640389T3 (en) * | 2010-11-17 | 2015-03-09 | Hexal Ag | Transdermal therapeutic system comprising buprenorphine |
| US20130096170A1 (en) * | 2011-10-14 | 2013-04-18 | Hospira, Inc. | Methods of treating pediatric patients using dexmedetomidine |
| KR101891186B1 (ko) * | 2013-10-07 | 2018-08-24 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 덱스메데토미딘 경피 조성물을 포함하는 통증을 관리하기 위한 방법 및 조성물 |
-
2014
- 2014-10-03 KR KR1020167011598A patent/KR101891186B1/ko active IP Right Grant
- 2014-10-03 CA CA2924188A patent/CA2924188C/en active Active
- 2014-10-03 WO PCT/US2014/059057 patent/WO2015054062A2/en active Application Filing
- 2014-10-03 KR KR1020187023714A patent/KR20180095733A/ko not_active Application Discontinuation
- 2014-10-03 EP EP14851606.5A patent/EP3054931B1/en active Active
- 2014-10-03 CN CN201910851561.5A patent/CN110604728A/zh active Pending
- 2014-10-03 TW TW103134523A patent/TWI629061B/zh active
- 2014-10-03 JP JP2016520593A patent/JP6188934B2/ja active Active
- 2014-10-03 US US14/505,941 patent/US20150098982A1/en not_active Abandoned
- 2014-10-03 RU RU2016109631A patent/RU2654702C2/ru active
- 2014-10-03 CN CN201480064109.XA patent/CN105764495A/zh active Pending
- 2014-10-03 ES ES14851606T patent/ES2855103T3/es active Active
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2017
- 2017-07-28 JP JP2017146472A patent/JP6522062B2/ja active Active
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2024
- 2024-03-29 US US18/621,397 patent/US20240245652A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| BR112016007327A2 (pt) | 2017-08-01 |
| JP6522062B2 (ja) | 2019-05-29 |
| KR20160062159A (ko) | 2016-06-01 |
| KR101891186B1 (ko) | 2018-08-24 |
| TWI629061B (zh) | 2018-07-11 |
| US20150098982A1 (en) | 2015-04-09 |
| CN105764495A (zh) | 2016-07-13 |
| JP6188934B2 (ja) | 2017-08-30 |
| WO2015054062A2 (en) | 2015-04-16 |
| RU2654702C2 (ru) | 2018-05-22 |
| KR20180095733A (ko) | 2018-08-27 |
| CN110604728A (zh) | 2019-12-24 |
| TW201524506A (zh) | 2015-07-01 |
| CA2924188C (en) | 2018-12-18 |
| EP3054931A2 (en) | 2016-08-17 |
| JP2018008984A (ja) | 2018-01-18 |
| CA2924188A1 (en) | 2015-04-16 |
| EP3054931A4 (en) | 2017-04-05 |
| EP3054931B1 (en) | 2020-12-23 |
| ES2855103T3 (es) | 2021-09-23 |
| JP2016532645A (ja) | 2016-10-20 |
| US20240245652A1 (en) | 2024-07-25 |
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