AU2015317336B2 - Eutectic formulations of Cyclobenzaprine hydrochloride - Google Patents

Eutectic formulations of Cyclobenzaprine hydrochloride Download PDF

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Publication number
AU2015317336B2
AU2015317336B2 AU2015317336A AU2015317336A AU2015317336B2 AU 2015317336 B2 AU2015317336 B2 AU 2015317336B2 AU 2015317336 A AU2015317336 A AU 2015317336A AU 2015317336 A AU2015317336 A AU 2015317336A AU 2015317336 B2 AU2015317336 B2 AU 2015317336B2
Authority
AU
Australia
Prior art keywords
mannitol
eutectic
cyclobenzaprine hcl
cyclobenzaprine
weight
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
AU2015317336A
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English (en)
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AU2015317336A1 (en
Inventor
Seth Lederman
Marino Nebuloni
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 Pharma Ltd Ireland
Original Assignee
Tonix Pharma Ltd Ireland
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 Pharma Ltd Ireland filed Critical Tonix Pharma Ltd Ireland
Publication of AU2015317336A1 publication Critical patent/AU2015317336A1/en
Priority to AU2020289838A priority Critical patent/AU2020289838B2/en
Application granted granted Critical
Publication of AU2015317336B2 publication Critical patent/AU2015317336B2/en
Assigned to TONIX PHARMA LIMITED reassignment TONIX PHARMA LIMITED Request for Assignment Assignors: TONIX PHARMA HOLDINGS LIMITED
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K31/13—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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Psychiatry (AREA)
  • Anesthesiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
AU2015317336A 2014-09-18 2015-09-18 Eutectic formulations of Cyclobenzaprine hydrochloride Active AU2015317336B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2020289838A AU2020289838B2 (en) 2014-09-18 2020-12-17 Eutectic formulations of Cyclobenzaprine hydrochloride

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462052238P 2014-09-18 2014-09-18
US62/052,238 2014-09-18
PCT/US2015/051068 WO2016044796A1 (en) 2014-09-18 2015-09-18 Eutectic formulations of cyclobenzaprine hydrochloride

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2020289838A Division AU2020289838B2 (en) 2014-09-18 2020-12-17 Eutectic formulations of Cyclobenzaprine hydrochloride

Publications (2)

Publication Number Publication Date
AU2015317336A1 AU2015317336A1 (en) 2017-04-13
AU2015317336B2 true AU2015317336B2 (en) 2021-01-21

Family

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AU2015317336A Active AU2015317336B2 (en) 2014-09-18 2015-09-18 Eutectic formulations of Cyclobenzaprine hydrochloride
AU2020289838A Active AU2020289838B2 (en) 2014-09-18 2020-12-17 Eutectic formulations of Cyclobenzaprine hydrochloride

Family Applications After (1)

Application Number Title Priority Date Filing Date
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Country Status (12)

Country Link
US (2) US10357465B2 (enExample)
EP (1) EP3193854A4 (enExample)
JP (6) JP6614724B2 (enExample)
CN (2) CN112618494B (enExample)
AU (2) AU2015317336B2 (enExample)
BR (1) BR112017005231A2 (enExample)
IL (2) IL251218B (enExample)
MX (1) MX387402B (enExample)
MY (1) MY186047A (enExample)
SG (2) SG11201701995PA (enExample)
WO (1) WO2016044796A1 (enExample)
ZA (1) ZA201701637B (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011062614A1 (en) 2009-11-20 2011-05-26 Tonix Pharmaceuticals, Inc. Methods and compositions for treating symptoms associated with post-traumatic stress disorder using cyclobenzaprine
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
NZ747040A (en) 2013-03-15 2020-02-28 Tonix Pharmaceuticals Inc Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride
SG11201701995PA (en) 2014-09-18 2017-04-27 Tonix Pharma Holdings Ltd Eutectic formulations of cyclobenzaprine hydrochloride
AU2018383098B2 (en) 2017-12-11 2024-12-12 Tonix Pharma Limited Cyclobenzaprine treatment for agitation, psychosis and cognitive decline in dementia and neurodegenerative conditions
CA3109258A1 (en) * 2018-08-20 2020-02-27 Tonix Pharma Holdings Limited Methods of treating acute stress disorder and posttraumatic stress disorder
NL2023661B1 (en) * 2019-08-19 2021-04-21 Seranovo Holding B V Pharmaceutical Eutectic Salt Formulation
CA3179754A1 (en) 2020-04-08 2021-10-14 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for sexual dysfunction
US20240009146A1 (en) * 2020-11-20 2024-01-11 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for alcohol use disorder
AU2021396509A1 (en) * 2020-12-07 2023-06-29 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for fibromyalgia
EP4412602A1 (en) * 2021-10-06 2024-08-14 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)
WO2025160302A1 (en) 2024-01-25 2025-07-31 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for acute stress reaction or acute stress disorder

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WO2014145156A2 (en) * 2013-03-15 2014-09-18 Tonix Pharmaceuticals, Inc. Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride

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Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999018937A1 (en) * 1997-10-16 1999-04-22 Merck & Co., Inc. New cyclobenzaprine composition
US20030077297A1 (en) * 1999-02-26 2003-04-24 Feng-Jing Chen Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
US20090098200A1 (en) * 2007-09-25 2009-04-16 Solubest Ltd. Compositions comprising lipophilic active compounds and method for their preparation
US20140171515A1 (en) * 2012-06-15 2014-06-19 Tonix Pharmaceuticals, Inc. Compositions and methods for transmucosal absorption
WO2014145156A2 (en) * 2013-03-15 2014-09-18 Tonix Pharmaceuticals, Inc. Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride

Also Published As

Publication number Publication date
AU2020289838B2 (en) 2022-11-24
JP2025107355A (ja) 2025-07-17
NZ730379A (en) 2023-10-27
US10357465B2 (en) 2019-07-23
US20170281568A1 (en) 2017-10-05
JP2018193409A (ja) 2018-12-06
ZA201701637B (en) 2020-11-25
SG11201701995PA (en) 2017-04-27
IL251218A0 (en) 2017-05-29
JP6614724B2 (ja) 2019-12-04
CN107072968A (zh) 2017-08-18
JP2022001605A (ja) 2022-01-06
CN112618494A (zh) 2021-04-09
CN112618494B (zh) 2023-06-30
MX387402B (es) 2025-03-18
JP6717902B6 (ja) 2020-08-05
EP3193854A4 (en) 2018-05-02
EP3193854A1 (en) 2017-07-26
AU2020289838A1 (en) 2021-01-28
SG10201902203VA (en) 2019-04-29
MY186047A (en) 2021-06-17
US11026898B2 (en) 2021-06-08
IL277814B (en) 2021-12-01
WO2016044796A1 (en) 2016-03-24
US20190336458A1 (en) 2019-11-07
MX2017003644A (es) 2017-10-31
CA2961822A1 (en) 2016-03-24
JP6717902B2 (ja) 2020-07-08
JP2020059757A (ja) 2020-04-16
IL277814A (en) 2020-11-30
JP2023126486A (ja) 2023-09-07
BR112017005231A2 (pt) 2018-03-13
NZ768064A (en) 2023-10-27
JP2017532374A (ja) 2017-11-02
AU2015317336A1 (en) 2017-04-13
CN107072968B (zh) 2021-01-12
IL251218B (en) 2020-10-29

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