CN115154440A - 含右美托咪定的膜制剂及其制造方法 - Google Patents

含右美托咪定的膜制剂及其制造方法 Download PDF

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Publication number
CN115154440A
CN115154440A CN202210529701.9A CN202210529701A CN115154440A CN 115154440 A CN115154440 A CN 115154440A CN 202210529701 A CN202210529701 A CN 202210529701A CN 115154440 A CN115154440 A CN 115154440A
Authority
CN
China
Prior art keywords
film
dexmedetomidine
composition
pharmaceutically acceptable
daltons
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.)
Pending
Application number
CN202210529701.9A
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English (en)
Chinese (zh)
Inventor
V.卡库马努
F.尤卡
C.D.拉蒂亚
D.C.汉雷
S.D.巴纳特
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.)
Alces Co ltd
Bioxcel Therapeutics Inc
Original Assignee
Alces Co ltd
Bioxcel Therapeutics 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 Alces Co ltd, Bioxcel Therapeutics Inc filed Critical Alces Co ltd
Publication of CN115154440A publication Critical patent/CN115154440A/zh
Pending legal-status Critical Current

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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
    • A61K9/0012—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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives 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
    • A61K9/0012—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
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61K9/7007—Drug-containing films, membranes or sheets

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN202210529701.9A 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法 Pending CN115154440A (zh)

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
US201862690407P 2018-06-27 2018-06-27
US62/690,407 2018-06-27
US201862693726P 2018-07-03 2018-07-03
US62/693,726 2018-07-03
US201862767422P 2018-11-14 2018-11-14
US62/767,422 2018-11-14
US201962787649P 2019-01-02 2019-01-02
US62/787,649 2019-01-02
US201962798842P 2019-01-30 2019-01-30
US62/798,842 2019-01-30
US201962849747P 2019-05-17 2019-05-17
US62/849,747 2019-05-17
CN201980050240.3A CN112888431B (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
PCT/US2019/039268 WO2020006092A1 (en) 2018-06-27 2019-06-26 Film formulations containing dexmedetomidine and methods of producing them

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201980050240.3A Division CN112888431B (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法

Publications (1)

Publication Number Publication Date
CN115154440A true CN115154440A (zh) 2022-10-11

Family

ID=68987261

Family Applications (5)

Application Number Title Priority Date Filing Date
CN202210529701.9A Pending CN115154440A (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
CN202210528428.8A Pending CN114983979A (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
CN201980050240.3A Active CN112888431B (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
CN202210529689.1A Pending CN114983981A (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
CN202210529685.3A Pending CN114983980A (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法

Family Applications After (4)

Application Number Title Priority Date Filing Date
CN202210528428.8A Pending CN114983979A (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
CN201980050240.3A Active CN112888431B (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
CN202210529689.1A Pending CN114983981A (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法
CN202210529685.3A Pending CN114983980A (zh) 2018-06-27 2019-06-26 含右美托咪定的膜制剂及其制造方法

Country Status (15)

Country Link
US (9) US10792246B2 (enExample)
EP (2) EP3813802B1 (enExample)
JP (2) JP7488201B2 (enExample)
KR (1) KR102824967B1 (enExample)
CN (5) CN115154440A (enExample)
AU (2) AU2019295699A1 (enExample)
BR (1) BR112020026672A2 (enExample)
CA (1) CA3103431A1 (enExample)
ES (1) ES3004544T3 (enExample)
IL (1) IL279713B2 (enExample)
MX (1) MX2020014000A (enExample)
PL (1) PL3813802T3 (enExample)
PT (1) PT3813802T (enExample)
SG (1) SG11202012772XA (enExample)
WO (1) WO2020006092A1 (enExample)

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PT3813802T (pt) 2018-06-27 2025-01-15 Arx Llc Formulações de películas contendo dexmedetomidina e métodos de produção das mesmas
WO2020006073A1 (en) 2018-06-28 2020-01-02 Arx, Llc Dispensing method for producing dissolvable unit dose film constructs
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CA3203241A1 (en) * 2021-01-04 2022-07-07 Robert RISINGER Dexmedetomidine treatment regimens
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US20250319069A1 (en) * 2021-07-02 2025-10-16 Bioxcel Therapeutics, Inc. Methods for treating depressive states
JP2025526428A (ja) 2022-07-27 2025-08-13 ウニヴェルジテート・チューリッヒ 睡眠障害を治療するためのデクスメデトミジン
JP2025531884A (ja) * 2022-09-11 2025-09-25 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 社会環境における激越の処置方法
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
WO2025043236A1 (en) * 2023-08-24 2025-02-27 Joseph Fuisz Edible oral films, compositions, method of manufacture and packaging systems
WO2025147530A1 (en) * 2024-01-05 2025-07-10 Taho Pharmaceuticals Ltd. Naloxone buccal film product and uses thereof
CN118542852B (zh) * 2024-07-30 2024-10-01 山东则正医药技术有限公司 包含经口给药的右美托咪定舌下膜组合物及其制备方法和应用
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