AU2013274003B2 - Compositions and methods for transmucosal absorption - Google Patents

Compositions and methods for transmucosal absorption Download PDF

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Publication number
AU2013274003B2
AU2013274003B2 AU2013274003A AU2013274003A AU2013274003B2 AU 2013274003 B2 AU2013274003 B2 AU 2013274003B2 AU 2013274003 A AU2013274003 A AU 2013274003A AU 2013274003 A AU2013274003 A AU 2013274003A AU 2013274003 B2 AU2013274003 B2 AU 2013274003B2
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AU
Australia
Prior art keywords
equal
administration
hours
composition
cyclobenzaprine
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
AU2013274003A
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English (en)
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AU2013274003A1 (en
Inventor
Harry Brittain
Seth Lederman
Giorgio Reiner
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
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Tonix Pharma Ltd Ireland
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Filing date
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Publication of AU2013274003A1 publication Critical patent/AU2013274003A1/en
Application granted granted Critical
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Priority to AU2018241128A priority Critical patent/AU2018241128B2/en
Assigned to TONIX PHARMA HOLDINGS LIMITED reassignment TONIX PHARMA HOLDINGS LIMITED Request for Assignment Assignors: Tonix Pharmaceuticals, Inc.
Assigned to TONIX PHARMA LIMITED reassignment TONIX PHARMA LIMITED Request for Assignment Assignors: TONIX PHARMA HOLDINGS LIMITED
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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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Anesthesiology (AREA)
  • Psychiatry (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)
  • Saccharide Compounds (AREA)
  • Pyridine Compounds (AREA)
  • Steroid Compounds (AREA)
AU2013274003A 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption Active AU2013274003B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2018241128A AU2018241128B2 (en) 2012-06-15 2018-10-04 Compositions and Methods for Transmucosal Absorption

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
AU2018241128A Division AU2018241128B2 (en) 2012-06-15 2018-10-04 Compositions and Methods for Transmucosal Absorption

Publications (2)

Publication Number Publication Date
AU2013274003A1 AU2013274003A1 (en) 2015-02-05
AU2013274003B2 true AU2013274003B2 (en) 2018-07-05

Family

ID=49758769

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2013274003A Active AU2013274003B2 (en) 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption
AU2018241128A Active AU2018241128B2 (en) 2012-06-15 2018-10-04 Compositions and Methods for Transmucosal Absorption

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2018241128A Active AU2018241128B2 (en) 2012-06-15 2018-10-04 Compositions and Methods for Transmucosal Absorption

Country Status (26)

Country Link
US (1) US20140171515A1 (enExample)
EP (1) EP2861223B1 (enExample)
JP (5) JP6259452B2 (enExample)
CN (2) CN111388430A (enExample)
AR (1) AR092330A1 (enExample)
AU (2) AU2013274003B2 (enExample)
BR (1) BR112014031394B1 (enExample)
CA (2) CA2876902C (enExample)
DK (1) DK2861223T3 (enExample)
ES (1) ES2929133T3 (enExample)
HR (1) HRP20221325T1 (enExample)
HU (1) HUE060175T2 (enExample)
IL (1) IL236268B (enExample)
LT (1) LT2861223T (enExample)
MX (2) MX382516B (enExample)
MY (1) MY194495A (enExample)
NZ (2) NZ631144A (enExample)
PL (1) PL2861223T3 (enExample)
PT (1) PT2861223T (enExample)
RS (1) RS63822B1 (enExample)
SG (2) SG11201408318RA (enExample)
SI (1) SI2861223T1 (enExample)
SM (1) SMT202200436T1 (enExample)
TW (3) TWI590820B (enExample)
WO (1) WO2013188847A1 (enExample)
ZA (1) ZA201500288B (enExample)

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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
US9636408B2 (en) 2013-03-15 2017-05-02 Tonix Pharma Holdings Limited Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride
SG10201902203VA (en) 2014-09-18 2019-04-29 Tonix Pharma Holdings Ltd Eutectic formulations of cyclobenzaprine hydrochloride
EP3322412B1 (en) * 2015-07-15 2021-04-07 Theranexus Use of amitriptyline for blocking brain hemichannels and method for potentiating its effect in vivo
US12337063B2 (en) * 2016-09-02 2025-06-24 University Of Sharjah Formulation for atropine sulfate rapidly-disintegrating sublingual tablets
WO2019014651A1 (en) * 2017-07-13 2019-01-17 Tonix Pharmaceuticals Holding Corp. ANALOGUES OF CYCLOBENZAPRINE AND AMITRYPTILENE
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
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
WO2019110723A1 (en) * 2017-12-08 2019-06-13 F. Hoffmann-La Roche Ag Pharmaceutical formulation
CA3083341C (en) 2017-12-11 2024-05-28 Tonix Pharma Holdings Limited Cyclobenzaprine treatment for agitation, psychosis and cognitive decline in dementia and neurodegenerative conditions
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
JP7691739B2 (ja) 2018-08-20 2025-06-12 トニックス ファーマ ホールディングス リミテッド 急性ストレス障害および外傷後ストレス障害を処置する方法
CA3156118A1 (en) * 2019-09-30 2021-04-08 Cadila Healthcare Limited Intranasal pharmaceutical compositions of cyclobenzaprine
JP7780447B2 (ja) 2020-04-08 2025-12-04 トニックス ファーマシューティカルズ ホールディング コーポレイション 性機能障害のシクロベンザプリン処置
MX2023005899A (es) 2020-11-20 2023-08-16 TONIX Pharmaceuticals Holding Corp Tratamiento con ciclobenzaprina para el trastorno por consumo de alcohol.
EP4255407A1 (en) 2020-12-07 2023-10-11 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
US20230414536A1 (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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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

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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
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Also Published As

Publication number Publication date
AU2018241128A1 (en) 2018-10-25
EP2861223A1 (en) 2015-04-22
WO2013188847A1 (en) 2013-12-19
IL236268B (en) 2022-03-01
RS63822B1 (sr) 2023-01-31
JP2019123757A (ja) 2019-07-25
TWI642429B (zh) 2018-12-01
MY194495A (en) 2022-11-30
PT2861223T (pt) 2022-11-07
BR112014031394B1 (pt) 2022-10-18
CA3118913C (en) 2024-04-30
MX382516B (es) 2025-03-13
NZ726488A (en) 2018-10-26
AU2018241128B2 (en) 2020-05-21
CA3118913A1 (en) 2013-12-19
JP6259452B2 (ja) 2018-01-10
EP2861223B1 (en) 2022-08-03
TWI590820B (zh) 2017-07-11
LT2861223T (lt) 2022-12-12
BR112014031394A8 (pt) 2021-11-03
SG11201408318RA (en) 2015-01-29
CA2876902A1 (en) 2013-12-19
CA2876902C (en) 2021-07-13
JP2017222726A (ja) 2017-12-21
HRP20221325T1 (hr) 2022-12-23
SG10201605407TA (en) 2016-08-30
TWI683660B (zh) 2020-02-01
BR112014031394A2 (pt) 2017-06-27
HK1209361A1 (en) 2016-04-01
PL2861223T3 (pl) 2022-12-12
TW201731494A (zh) 2017-09-16
ES2929133T3 (es) 2022-11-25
HUE060175T2 (hu) 2023-02-28
TW201842903A (zh) 2018-12-16
TW201408281A (zh) 2014-03-01
CN111388430A (zh) 2020-07-10
DK2861223T3 (da) 2022-11-07
JP2024032964A (ja) 2024-03-12
MX2014015436A (es) 2015-07-14
US20140171515A1 (en) 2014-06-19
JP2021138765A (ja) 2021-09-16
ZA201500288B (en) 2022-05-25
AU2013274003A1 (en) 2015-02-05
IL236268A0 (en) 2015-02-26
SMT202200436T1 (it) 2023-01-13
AR092330A1 (es) 2015-04-15
EP2861223A4 (en) 2016-01-27
SI2861223T1 (sl) 2023-01-31
NZ631144A (en) 2016-12-23
WO2013188847A8 (en) 2015-02-05
JP2015519404A (ja) 2015-07-09
MX2021005317A (es) 2022-12-16
CN104684550A (zh) 2015-06-03

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MK1 Application lapsed section 142(2)(a) - no request for examination in relevant period
NB Applications allowed - extensions of time section 223(2)

Free format text: THE TIME IN WHICH TO REQUEST EXAMINATION HAS BEEN EXTENDED TO 23 NOV 2016

FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: TONIX PHARMA HOLDINGS LIMITED

Free format text: FORMER OWNER(S): TONIX PHARMACEUTICALS, INC.

PC Assignment registered

Owner name: TONIX PHARMA LIMITED

Free format text: FORMER OWNER(S): TONIX PHARMA HOLDINGS LIMITED