CN104684550A - 用于跨粘膜吸收的组合物和方法 - Google Patents

用于跨粘膜吸收的组合物和方法 Download PDF

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Publication number
CN104684550A
CN104684550A CN201380039522.6A CN201380039522A CN104684550A CN 104684550 A CN104684550 A CN 104684550A CN 201380039522 A CN201380039522 A CN 201380039522A CN 104684550 A CN104684550 A CN 104684550A
Authority
CN
China
Prior art keywords
cyclobenzaprine
equal
administration
compositions
hours
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
CN201380039522.6A
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English (en)
Chinese (zh)
Inventor
S·雷德曼
G·雷纳
H·布里坦
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.)
Tonix Pharmaceuticals Inc
Original Assignee
Tonix Pharmaceuticals 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 Tonix Pharmaceuticals Inc filed Critical Tonix Pharmaceuticals Inc
Priority to CN202010024102.2A priority Critical patent/CN111388430A/zh
Publication of CN104684550A publication Critical patent/CN104684550A/zh
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • 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
    • A61P25/04—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyridine Compounds (AREA)
  • Steroid Compounds (AREA)
  • Saccharide Compounds (AREA)
CN201380039522.6A 2012-06-15 2013-06-14 用于跨粘膜吸收的组合物和方法 Pending CN104684550A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202010024102.2A CN111388430A (zh) 2012-06-15 2013-06-14 用于跨粘膜吸收的组合物和方法

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201261660593P 2012-06-15 2012-06-15
US61/660,593 2012-06-15
US201261667774P 2012-07-03 2012-07-03
US61/667,774 2012-07-03
US201261725402P 2012-11-12 2012-11-12
US61/725,402 2012-11-12
US201361792900P 2013-03-15 2013-03-15
US61/792,900 2013-03-15
PCT/US2013/046023 WO2013188847A1 (en) 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202010024102.2A Division CN111388430A (zh) 2012-06-15 2013-06-14 用于跨粘膜吸收的组合物和方法

Publications (1)

Publication Number Publication Date
CN104684550A true CN104684550A (zh) 2015-06-03

Family

ID=49758769

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201380039522.6A Pending CN104684550A (zh) 2012-06-15 2013-06-14 用于跨粘膜吸收的组合物和方法
CN202010024102.2A Pending CN111388430A (zh) 2012-06-15 2013-06-14 用于跨粘膜吸收的组合物和方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202010024102.2A Pending CN111388430A (zh) 2012-06-15 2013-06-14 用于跨粘膜吸收的组合物和方法

Country Status (26)

Country Link
US (1) US20140171515A1 (https=)
EP (1) EP2861223B1 (https=)
JP (5) JP6259452B2 (https=)
CN (2) CN104684550A (https=)
AR (1) AR092330A1 (https=)
AU (2) AU2013274003B2 (https=)
BR (1) BR112014031394B1 (https=)
CA (2) CA3118913C (https=)
DK (1) DK2861223T3 (https=)
ES (1) ES2929133T3 (https=)
HR (1) HRP20221325T1 (https=)
HU (1) HUE060175T2 (https=)
IL (1) IL236268B (https=)
LT (1) LT2861223T (https=)
MX (2) MX382516B (https=)
MY (1) MY194495A (https=)
NZ (2) NZ726488A (https=)
PL (1) PL2861223T3 (https=)
PT (1) PT2861223T (https=)
RS (1) RS63822B1 (https=)
SG (2) SG10201605407TA (https=)
SI (1) SI2861223T1 (https=)
SM (1) SMT202200436T1 (https=)
TW (3) TWI642429B (https=)
WO (1) WO2013188847A1 (https=)
ZA (1) ZA201500288B (https=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107496355A (zh) * 2017-08-24 2017-12-22 青岛正大海尔制药有限公司 一种盐酸环苯扎林舌下喷雾剂及其制备方法
CN107519142A (zh) * 2017-08-24 2017-12-29 青岛正大海尔制药有限公司 一种盐酸环苯扎林舌下片及其制备方法
CN108721240A (zh) * 2018-06-08 2018-11-02 华益药业科技(安徽)有限公司 一种25mg阿米替林薄膜包衣片处方和工艺规程

Families Citing this family (20)

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Publication number Priority date Publication date Assignee Title
HRP20171739T1 (hr) 2009-11-20 2018-03-09 Tonix Pharma Holdings Limited Postupci i kompozicije za liječenje simptoma povezanih s posttraumatskim stresnim poremećajem korištenjem ciklobenzaprina
US20110319389A1 (en) 2010-06-24 2011-12-29 Tonix Pharmaceuticals, Inc. Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine
US11998516B2 (en) 2011-03-07 2024-06-04 Tonix Pharma Holdings Limited Methods and compositions for treating depression using cyclobenzaprine
JP6310542B2 (ja) 2013-03-15 2018-04-11 トニックス ファーマシューティカルズ， インコーポレイテッド シクロベンザプリン塩酸塩およびアミトリプチリン塩酸塩の共融製剤
SG11201701995PA (en) 2014-09-18 2017-04-27 Tonix Pharma Holdings Ltd Eutectic formulations of cyclobenzaprine hydrochloride
MX386469B (es) * 2015-07-15 2025-03-18 Theranexus Uso de amitriptilina para el bloqueo de hemicanales en el cerebro y metodo para la potenciacion de este efecto in vivo.
WO2018045367A1 (en) * 2016-09-02 2018-03-08 Nova Southeastern University Atropine sulfate rapidly-disintegrating sublingual tablets for treatment of acute organophosphate toxicity
EP3651751A4 (en) 2017-07-13 2021-03-31 Tonix Pharmaceuticals Holding Corp. CYCLOBENZAPRINE AND AMITRYPTILENE ANALOGUES
KR102704497B1 (ko) * 2017-12-08 2024-09-10 에프. 호프만-라 로슈 아게 약학 제형
US11826321B2 (en) 2017-12-11 2023-11-28 Tonix Pharma Holdings Limited Cyclobenzaprine treatment for agitation, psychosis and cognitive decline in dementia and neurodegenerative conditions
TW202019400A (zh) 2018-08-20 2020-06-01 愛爾蘭商托尼克製藥控股有限公司 治療急性壓力症候群及創傷後壓力症候群之方法
US20220339124A1 (en) * 2019-09-30 2022-10-27 Cadila Healthcare Limited Intranasal pharmaceutical compositions of cyclobenzaprine
AU2021253592A1 (en) * 2020-04-08 2022-11-10 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for sexual dysfunction
MX2023005899A (es) * 2020-11-20 2023-08-16 TONIX Pharmaceuticals Holding Corp Tratamiento con ciclobenzaprina para el trastorno por consumo de alcohol.
AU2021396509A1 (en) 2020-12-07 2023-06-29 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for fibromyalgia
WO2022170107A2 (en) 2021-02-04 2022-08-11 Tonix Pharmaceuticals Holding Corp. An improved method of assessing clinical response in the treatment of ptsd symptoms
US20240415789A1 (en) 2021-10-06 2024-12-19 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine for treatment or prevention of sexual dysfunction associated with mental health conditions in female patients
WO2023250036A1 (en) 2022-06-21 2023-12-28 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for post-acute sequelae of (sars)-cov-2 infection (pasc)
JP2025067457A (ja) * 2023-10-13 2025-04-24 株式会社島津製作所 液体クロマトグラフにおけるコストパフォーマンスの算出方法、プログラム、および、解析装置
WO2025160302A1 (en) 2024-01-25 2025-07-31 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for acute stress reaction or acute stress disorder

Citations (4)

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US4968507A (en) * 1984-06-20 1990-11-06 Merck & Co., Inc. Controlled porosity osmotic pump
WO1999058115A1 (en) * 1998-05-14 1999-11-18 Alza Corporation Antidepressant therapy
WO2001089476A1 (en) * 2000-05-19 2001-11-29 Npd Llc Chewing gums, lozenges, candies, tablets, liquids, and sprays for efficient delivery of medications and dietary supplements
US20030077227A1 (en) * 1997-10-01 2003-04-24 Dugger Harry A. Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system

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WO1999018937A1 (en) * 1997-10-16 1999-04-22 Merck & Co., Inc. New cyclobenzaprine composition
WO2001012175A1 (en) 1999-08-13 2001-02-22 Vela Pharmaceuticals Inc. Uses compositions for treating or preventing sleep disturbances using very low doses of cyclobenzaprine
BR0013122A (pt) 1999-08-13 2002-04-30 Vela Pharmaceuticals Inc Ciclobenzaprina para tratamento de distúrbio de ansiedade generalizado e composições de ciclobenzaprina
WO2002094229A1 (en) * 2001-05-24 2002-11-28 Alexza Molecular Delivery Corporation Delivery of muscle relaxants through an inhalation route
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WO2006105205A1 (en) * 2005-03-29 2006-10-05 University Of Kentucky Research Foundation Sublingual spray for the treatment of pain
US20090148532A1 (en) * 2007-12-06 2009-06-11 Venkatesh Gopi M Preparation of controlled release skeletal muscle relaxant dosage forms
JP2009079060A (ja) * 2008-10-15 2009-04-16 Novadel Pharma Inc 極性または非極性の、バッカルスプレーまたはカプセル
US20100266682A1 (en) * 2008-12-10 2010-10-21 Nipun Davar Polyethylene glycol-coated sodium carbonate as a pharmaceutical excipient and compositions produced from the same
US20100247586A1 (en) * 2009-03-27 2010-09-30 Andreas Hugerth Multi-Portion Intra-Oral Dosage Form With Organoleptic Properties
HRP20171739T1 (hr) * 2009-11-20 2018-03-09 Tonix Pharma Holdings Limited Postupci i kompozicije za liječenje simptoma povezanih s posttraumatskim stresnim poremećajem korištenjem ciklobenzaprina
US20110319389A1 (en) * 2010-06-24 2011-12-29 Tonix Pharmaceuticals, Inc. Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine
ITMI20110558A1 (it) * 2011-04-06 2012-10-07 Campiglio Consulting Srl Composizione farmaceutica contenente ciclobenzaprina adatta alla somministrazione endonasale
JP6310542B2 (ja) * 2013-03-15 2018-04-11 トニックス ファーマシューティカルズ， インコーポレイテッド シクロベンザプリン塩酸塩およびアミトリプチリン塩酸塩の共融製剤

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4968507A (en) * 1984-06-20 1990-11-06 Merck & Co., Inc. Controlled porosity osmotic pump
US20030077227A1 (en) * 1997-10-01 2003-04-24 Dugger Harry A. Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system
WO1999058115A1 (en) * 1998-05-14 1999-11-18 Alza Corporation Antidepressant therapy
WO2001089476A1 (en) * 2000-05-19 2001-11-29 Npd Llc Chewing gums, lozenges, candies, tablets, liquids, and sprays for efficient delivery of medications and dietary supplements

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107496355A (zh) * 2017-08-24 2017-12-22 青岛正大海尔制药有限公司 一种盐酸环苯扎林舌下喷雾剂及其制备方法
CN107519142A (zh) * 2017-08-24 2017-12-29 青岛正大海尔制药有限公司 一种盐酸环苯扎林舌下片及其制备方法
CN107519142B (zh) * 2017-08-24 2021-02-26 正大制药（青岛）有限公司 一种盐酸环苯扎林舌下片及其制备方法
CN107496355B (zh) * 2017-08-24 2021-04-30 正大制药（青岛）有限公司 一种盐酸环苯扎林舌下喷雾剂及其制备方法
CN108721240A (zh) * 2018-06-08 2018-11-02 华益药业科技(安徽)有限公司 一种25mg阿米替林薄膜包衣片处方和工艺规程

Also Published As

Publication number Publication date
HRP20221325T1 (hr) 2022-12-23
JP2015519404A (ja) 2015-07-09
MX2021005317A (es) 2022-12-16
MX2014015436A (es) 2015-07-14
ZA201500288B (en) 2022-05-25
ES2929133T3 (es) 2022-11-25
RS63822B1 (sr) 2023-01-31
CA3118913A1 (en) 2013-12-19
MY194495A (en) 2022-11-30
TWI590820B (zh) 2017-07-11
TWI642429B (zh) 2018-12-01
WO2013188847A1 (en) 2013-12-19
TW201842903A (zh) 2018-12-16
DK2861223T3 (da) 2022-11-07
JP2024032964A (ja) 2024-03-12
NZ631144A (en) 2016-12-23
WO2013188847A8 (en) 2015-02-05
AU2013274003A1 (en) 2015-02-05
AU2018241128B2 (en) 2020-05-21
JP6259452B2 (ja) 2018-01-10
BR112014031394A8 (pt) 2021-11-03
SMT202200436T1 (it) 2023-01-13
CA2876902A1 (en) 2013-12-19
SI2861223T1 (sl) 2023-01-31
MX382516B (es) 2025-03-13
NZ726488A (en) 2018-10-26
PT2861223T (pt) 2022-11-07
JP2021138765A (ja) 2021-09-16
CA3118913C (en) 2024-04-30
SG10201605407TA (en) 2016-08-30
BR112014031394A2 (pt) 2017-06-27
PL2861223T3 (pl) 2022-12-12
SG11201408318RA (en) 2015-01-29
US20140171515A1 (en) 2014-06-19
JP2017222726A (ja) 2017-12-21
EP2861223A4 (en) 2016-01-27
HK1209361A1 (en) 2016-04-01
TWI683660B (zh) 2020-02-01
IL236268B (en) 2022-03-01
EP2861223B1 (en) 2022-08-03
JP2019123757A (ja) 2019-07-25
EP2861223A1 (en) 2015-04-22
HUE060175T2 (hu) 2023-02-28
AR092330A1 (es) 2015-04-15
AU2013274003B2 (en) 2018-07-05
LT2861223T (lt) 2022-12-12
TW201408281A (zh) 2014-03-01
AU2018241128A1 (en) 2018-10-25
TW201731494A (zh) 2017-09-16
IL236268A0 (en) 2015-02-26
BR112014031394B1 (pt) 2022-10-18
CA2876902C (en) 2021-07-13
CN111388430A (zh) 2020-07-10

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