JP2017534613A - デクスメデトミジン製剤を使用する睡眠障害の予防または治療 - Google Patents
デクスメデトミジン製剤を使用する睡眠障害の予防または治療 Download PDFInfo
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- JP2017534613A JP2017534613A JP2017520539A JP2017520539A JP2017534613A JP 2017534613 A JP2017534613 A JP 2017534613A JP 2017520539 A JP2017520539 A JP 2017520539A JP 2017520539 A JP2017520539 A JP 2017520539A JP 2017534613 A JP2017534613 A JP 2017534613A
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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P25/20—Hypnotics; Sedatives
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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Abstract
Description
Claims (21)
- 被験体の口腔粘膜を通過するデクスメデトミジンの送達のために製剤化された、治療法上効果的な量のデクスメデトミジンまたはその薬学的に許容される塩、その溶媒和物もしくはその誘導体を含む、組成物。
- 前記デクスメデトミジンまたはその薬学的に許容される塩、その溶媒和物もしくはその誘導体が、舌下経路を介する送達のために製剤化される、請求項1に記載の組成物。
- 前記デクスメデトミジンの治療法上効果的な量が、約0.1mg〜約5mgの範囲内である、先行請求項のいずれか一項に記載の組成物。
- α2−アドレナリン受容体アゴニストによる治療に感受性のある疾患または病態に罹患する患者を選択すること、及び治療法上効果的な量のデクスメデトミジンまたはその薬学的に許容される塩、その溶媒和物もしくはその誘導体を患者へ投与することを含む、α2−アドレナリン受容体アゴニストによる治療に感受性のある疾患または病態を治療または予防する方法。
- 睡眠障害に罹患する患者を選択すること、及び治療法上効果的な量のデクスメデトミジンまたはその薬学的に許容される塩、その溶媒和物もしくはその誘導体を患者へ投与することを含む、睡眠障害を治療する方法。
- 投与が口腔粘膜へ適用することを含み、前記デクスメデトミジンまたはその薬学的に許容される塩もしくはその誘導体が、口腔粘膜を介して吸収される、請求項4または5に記載の方法。
- 前記デクスメデトミジンまたはその薬学的に許容される塩もしくはその誘導体が、舌下経路を介して送達される、請求項6に記載の方法。
- 前記睡眠障害が不眠症である、請求項5に記載の方法。
- 前記不眠症が、入眠障害不眠症、睡眠維持障害不眠症、早朝覚醒不眠症、一過性不眠症、真夜中不眠症、深夜不眠症、入眠後覚醒延長障害不眠症、及び睡眠維持障害不眠症である、請求項8に記載の方法。
- 睡眠障害の治療のためのデクスメデトミジン医薬製剤の使用。
- 前記睡眠障害が不眠症である、請求項10に記載の使用。
- 前記不眠症が、入眠障害不眠症、睡眠維持障害不眠症、早朝覚醒不眠症、一過性不眠症、真夜中不眠症、深夜不眠症、入眠後覚醒延長障害不眠症、及び睡眠維持障害不眠症である、請求項11に記載の使用。
- デクスメデトミジンの送達が被験体の口腔粘膜を通過する、請求項10に記載の使用。
- 前記デクスメデトミジンの送達が舌下経路を介する、請求項10に記載の使用。
- 前記デクスメデトミジンが、約0.1mg〜約5mgの範囲内で投与される、先行請求項のいずれかに記載の方法または使用。
- 治療のための実効時間が、約3〜約30分の範囲中である、先行請求項のいずれかに記載の方法または使用。
- 慢性疼痛が睡眠障害の主要な理由である、睡眠障害の治療のためのデクスメデトミジン医薬製剤の使用。
- 効果的な量のデクスメデトミジンまたはその薬学的に許容される塩を舌下に投与することを含む、哺乳類における不眠症を治療する追加の利益を備えて慢性疼痛を治療する方法。
- 前記方法が慢性疼痛に起因する睡眠障害を有する患者に好適である、請求項5に記載の方法。
- 前頭側頭認知症に罹患する患者の治療のためのデクスメデトミジン医薬製剤の使用。
- 興奮性不眠及び/または過覚醒と関連する不眠症に罹患する患者の治療のためのデクスメデトミジン医薬製剤の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201462064205P | 2014-10-15 | 2014-10-15 | |
US62/064,205 | 2014-10-15 | ||
PCT/US2015/055828 WO2016061413A1 (en) | 2014-10-15 | 2015-10-15 | Prevention or treatment of sleep disorders using dexmedetomidine formulation |
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JP2021025810A Division JP2021080276A (ja) | 2014-10-15 | 2021-02-22 | デクスメデトミジン製剤を使用する睡眠障害の予防または治療 |
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JP2017534613A true JP2017534613A (ja) | 2017-11-24 |
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JP2017520539A Pending JP2017534613A (ja) | 2014-10-15 | 2015-10-15 | デクスメデトミジン製剤を使用する睡眠障害の予防または治療 |
JP2021025810A Pending JP2021080276A (ja) | 2014-10-15 | 2021-02-22 | デクスメデトミジン製剤を使用する睡眠障害の予防または治療 |
JP2023034704A Pending JP2023076465A (ja) | 2014-10-15 | 2023-03-07 | デクスメデトミジン製剤を使用する睡眠障害の予防または治療 |
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JP2021025810A Pending JP2021080276A (ja) | 2014-10-15 | 2021-02-22 | デクスメデトミジン製剤を使用する睡眠障害の予防または治療 |
JP2023034704A Pending JP2023076465A (ja) | 2014-10-15 | 2023-03-07 | デクスメデトミジン製剤を使用する睡眠障害の予防または治療 |
Country Status (5)
Country | Link |
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US (2) | US20170239221A1 (ja) |
EP (1) | EP3206685B1 (ja) |
JP (3) | JP2017534613A (ja) |
MA (1) | MA41689A (ja) |
WO (1) | WO2016061413A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2021529756A (ja) * | 2018-06-27 | 2021-11-04 | バイオエクセル セラピューティクス,インコーポレイテッド | デクスメデトミジンを含むフィルム製剤、及びその作製方法 |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
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BR112019013503A2 (pt) | 2016-12-31 | 2020-01-07 | Bioxcel Therapeutics, Inc. | Uso de dexmedetomidina sublingual para o tratamento da agitação |
CA3145388A1 (en) | 2019-07-19 | 2021-01-28 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
CN113827590A (zh) * | 2020-06-08 | 2021-12-24 | 四川普锐特药业有限公司 | 右美托咪定在助眠药物制备中的应用 |
JP2024511394A (ja) | 2021-03-19 | 2024-03-13 | オリオン コーポレーション | タシピミジン製剤およびその使用 |
WO2024023261A1 (en) | 2022-07-27 | 2024-02-01 | Universität Zürich | Dexmedetomidine for the treatment of sleep disorders |
US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
CN117771220B (zh) * | 2024-02-28 | 2024-05-28 | 山东第二医科大学 | 一种右美托咪定中药多糖口溶膜剂及其制备方法和应用 |
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- 2015-10-14 MA MA041689A patent/MA41689A/fr unknown
- 2015-10-15 JP JP2017520539A patent/JP2017534613A/ja active Pending
- 2015-10-15 WO PCT/US2015/055828 patent/WO2016061413A1/en active Application Filing
- 2015-10-15 US US15/519,463 patent/US20170239221A1/en not_active Abandoned
- 2015-10-15 EP EP15850725.1A patent/EP3206685B1/en active Active
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2021
- 2021-02-22 JP JP2021025810A patent/JP2021080276A/ja active Pending
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2023
- 2023-03-07 JP JP2023034704A patent/JP2023076465A/ja active Pending
- 2023-09-05 US US18/242,236 patent/US20230414572A1/en not_active Abandoned
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JP2021529756A (ja) * | 2018-06-27 | 2021-11-04 | バイオエクセル セラピューティクス,インコーポレイテッド | デクスメデトミジンを含むフィルム製剤、及びその作製方法 |
JP7488201B2 (ja) | 2018-06-27 | 2024-05-21 | バイオエクセル セラピューティクス,インコーポレイテッド | デクスメデトミジンを含むフィルム製剤、及びその作製方法 |
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JP2023076465A (ja) | 2023-06-01 |
EP3206685B1 (en) | 2024-05-08 |
US20170239221A1 (en) | 2017-08-24 |
US20230414572A1 (en) | 2023-12-28 |
EP3206685A1 (en) | 2017-08-23 |
WO2016061413A1 (en) | 2016-04-21 |
MA41689A (fr) | 2017-08-22 |
EP3206685A4 (en) | 2018-06-20 |
JP2021080276A (ja) | 2021-05-27 |
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