CA2876902C - Compositions and methods for transmucosal absorption - Google Patents

Compositions and methods for transmucosal absorption Download PDF

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Publication number
CA2876902C
CA2876902C CA2876902A CA2876902A CA2876902C CA 2876902 C CA2876902 C CA 2876902C CA 2876902 A CA2876902 A CA 2876902A CA 2876902 A CA2876902 A CA 2876902A CA 2876902 C CA2876902 C CA 2876902C
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CA
Canada
Prior art keywords
equal
administration
cyclobenzaprine
composition
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.)
Active
Application number
CA2876902A
Other languages
English (en)
French (fr)
Other versions
CA2876902A1 (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 Holdings Ltd
Original Assignee
Tonix Pharma Holdings Ltd
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 Holdings Ltd filed Critical Tonix Pharma Holdings Ltd
Priority to CA3118913A priority Critical patent/CA3118913C/en
Publication of CA2876902A1 publication Critical patent/CA2876902A1/en
Application granted granted Critical
Publication of CA2876902C publication Critical patent/CA2876902C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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
    • 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)
  • Chemical Kinetics & Catalysis (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)
  • 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)
  • Saccharide Compounds (AREA)
  • Pyridine Compounds (AREA)
  • Steroid Compounds (AREA)
CA2876902A 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption Active CA2876902C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3118913A CA3118913C (en) 2012-06-15 2013-06-14 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
CA3118913A Division CA3118913C (en) 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption

Publications (2)

Publication Number Publication Date
CA2876902A1 CA2876902A1 (en) 2013-12-19
CA2876902C true CA2876902C (en) 2021-07-13

Family

ID=49758769

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2876902A Active CA2876902C (en) 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption
CA3118913A Active CA3118913C (en) 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3118913A Active CA3118913C (en) 2012-06-15 2013-06-14 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)

Families Citing this family (22)

* 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
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

Family Cites Families (18)

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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
WO1999018937A1 (en) * 1997-10-16 1999-04-22 Merck & Co., Inc. New cyclobenzaprine composition
DE69904465T2 (de) * 1998-05-14 2003-10-02 Alza Corp., Mountain View Therapie von depressionen
JP2003506484A (ja) 1999-08-13 2003-02-18 ベラ・ファーマシューティカルズ・インコーポレイテッド 非常に低用量のシクロベンザプリンを使用する睡眠障害の処置または予防するための組成物使用
MXPA02001568A (es) 1999-08-13 2002-07-02 Vela Pharmaceuticals Inc Ciclobenzaprina para tratar trastornos de ansiedad generalizada y composiciones de la misma.
AU2001261744A1 (en) * 2000-05-19 2001-12-03 Npd Llc Chewing gums, lozenges, candies, tablets, liquids, and sprays for efficient delivery of medications and dietary supplements
WO2002094229A1 (en) * 2001-05-24 2002-11-28 Alexza Molecular Delivery Corporation Delivery of muscle relaxants through an inhalation route
CA2515146C (en) * 2003-02-04 2011-12-06 Chrysalis Technologies Incorporated Aerosol formulations and aerosol delivery of buspirone, buprenorphine, triazolam, cyclobenzaprine and zolpidem
US20090117054A1 (en) * 2005-03-29 2009-05-07 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
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
ITMI20110558A1 (it) * 2011-04-06 2012-10-07 Campiglio Consulting Srl Composizione farmaceutica contenente ciclobenzaprina adatta alla somministrazione endonasale
US9636408B2 (en) * 2013-03-15 2017-05-02 Tonix Pharma Holdings Limited Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride

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
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
AU2013274003B2 (en) 2018-07-05
CN104684550A (zh) 2015-06-03

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