BR112014031394B1 - Composições adequadas para absorção transmucosa oral compreendendo ciclobenzaprina ou amitriptilina e usos das mesmas - Google Patents

Composições adequadas para absorção transmucosa oral compreendendo ciclobenzaprina ou amitriptilina e usos das mesmas Download PDF

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Publication number
BR112014031394B1
BR112014031394B1 BR112014031394-6A BR112014031394A BR112014031394B1 BR 112014031394 B1 BR112014031394 B1 BR 112014031394B1 BR 112014031394 A BR112014031394 A BR 112014031394A BR 112014031394 B1 BR112014031394 B1 BR 112014031394B1
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BR
Brazil
Prior art keywords
equal
administration
hours
cyclobenzaprine
composition
Prior art date
Application number
BR112014031394-6A
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English (en)
Portuguese (pt)
Other versions
BR112014031394A2 (pt
BR112014031394A8 (pt
Inventor
Seth Lederman
Giorgio Reiner
Harry BRITTAIN
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.)
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Publication date
Application filed by Tonix Pharmaceuticals, Inc filed Critical Tonix Pharmaceuticals, Inc
Publication of BR112014031394A2 publication Critical patent/BR112014031394A2/pt
Publication of BR112014031394A8 publication Critical patent/BR112014031394A8/pt
Publication of BR112014031394B1 publication Critical patent/BR112014031394B1/pt

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02Muscle relaxants, e.g. for tetanus or cramps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants

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  • 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)
  • Steroid Compounds (AREA)
  • Pyridine Compounds (AREA)
  • Saccharide Compounds (AREA)
BR112014031394-6A 2012-06-15 2013-06-14 Composições adequadas para absorção transmucosa oral compreendendo ciclobenzaprina ou amitriptilina e usos das mesmas BR112014031394B1 (pt)

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

Publications (3)

Publication Number Publication Date
BR112014031394A2 BR112014031394A2 (pt) 2017-06-27
BR112014031394A8 BR112014031394A8 (pt) 2021-11-03
BR112014031394B1 true BR112014031394B1 (pt) 2022-10-18

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014031394-6A BR112014031394B1 (pt) 2012-06-15 2013-06-14 Composições adequadas para absorção transmucosa oral compreendendo ciclobenzaprina ou amitriptilina e usos das mesmas

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) MX2021005317A (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) TWI683660B (enExample)
WO (1) WO2013188847A1 (enExample)
ZA (1) ZA201500288B (enExample)

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HUE037281T2 (hu) 2009-11-20 2018-08-28 Tonix Pharma Holdings Ltd Eljárás és készítmény poszt-traumás stressz rendellenesség tüneteinek kezelésére ciklobenzaprin alkalmazásával
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
ES2769879T3 (es) 2013-03-15 2020-06-29 Tonix Pharma Holdings Ltd Formulaciones eutécticas de clorhidrato de ciclobenzaprina y manitol
CN107072968B (zh) 2014-09-18 2021-01-12 通尼克斯制药控股有限公司 环苯扎林盐酸盐的低共熔混合物配制剂
CN108024976A (zh) * 2015-07-15 2018-05-11 特兰埃克斯公司 阿米替林用于阻断大脑半通道的用途和用于增强其体内作用的方法
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
IL275144B2 (en) * 2017-12-08 2024-12-01 Hoffmann La Roche Pharmaceutical formulation
MX2020006140A (es) 2017-12-11 2020-08-13 Tonix Pharma Holdings Ltd Tratamiento con ciclobenzaprina para la agitacion, psicosis y deterioro cognitivo en la demencia y enfermedades neurodegenerativas.
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
US20220339124A1 (en) * 2019-09-30 2022-10-27 Cadila Healthcare Limited Intranasal pharmaceutical compositions of cyclobenzaprine
US20210315841A1 (en) * 2020-04-08 2021-10-14 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.
MX2023006720A (es) 2020-12-07 2023-08-18 TONIX Pharmaceuticals Holding Corp Tratamiento con ciclobenzaprina para fibromialgia.
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
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
JP2025519847A (ja) 2022-06-21 2025-06-26 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 (SARS)-CoV-2感染症の急性期後後遺症(PASC)のためのシクロベンザプリン処置
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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US4968507A (en) * 1984-06-20 1990-11-06 Merck & Co., Inc. Controlled porosity osmotic pump
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WO1999018937A1 (en) * 1997-10-16 1999-04-22 Merck & Co., Inc. New cyclobenzaprine composition
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AR025110A1 (es) 1999-08-13 2002-11-06 Vela Pharmaceuticals Inc Metodos y composiciones para tratar o prevenir alteraciones del sueno y enfermedades asociadas usando dosis muy bajas de ciclobenzaprina
BR0013122A (pt) 1999-08-13 2002-04-30 Vela Pharmaceuticals Inc Ciclobenzaprina para tratamento de distúrbio de ansiedade generalizado e composições de ciclobenzaprina
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
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US20090117054A1 (en) * 2005-03-29 2009-05-07 University Of Kentucky Research Foundation Sublingual spray for the treatment of pain
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HUE037281T2 (hu) * 2009-11-20 2018-08-28 Tonix Pharma Holdings Ltd Eljárás és készítmény poszt-traumás stressz rendellenesség tüneteinek kezelésére ciklobenzaprin alkalmazásával
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
ES2769879T3 (es) * 2013-03-15 2020-06-29 Tonix Pharma Holdings Ltd Formulaciones eutécticas de clorhidrato de ciclobenzaprina y manitol

Also Published As

Publication number Publication date
TW201842903A (zh) 2018-12-16
CA3118913A1 (en) 2013-12-19
TWI642429B (zh) 2018-12-01
CA2876902A1 (en) 2013-12-19
ES2929133T3 (es) 2022-11-25
JP2021138765A (ja) 2021-09-16
ZA201500288B (en) 2022-05-25
EP2861223B1 (en) 2022-08-03
JP2017222726A (ja) 2017-12-21
SMT202200436T1 (it) 2023-01-13
TW201408281A (zh) 2014-03-01
JP6259452B2 (ja) 2018-01-10
AU2013274003A1 (en) 2015-02-05
LT2861223T (lt) 2022-12-12
EP2861223A1 (en) 2015-04-22
JP2015519404A (ja) 2015-07-09
PL2861223T3 (pl) 2022-12-12
TW201731494A (zh) 2017-09-16
NZ631144A (en) 2016-12-23
TWI683660B (zh) 2020-02-01
MX382516B (es) 2025-03-13
NZ726488A (en) 2018-10-26
EP2861223A4 (en) 2016-01-27
JP2019123757A (ja) 2019-07-25
CA2876902C (en) 2021-07-13
SG11201408318RA (en) 2015-01-29
AR092330A1 (es) 2015-04-15
MY194495A (en) 2022-11-30
DK2861223T3 (da) 2022-11-07
JP2024032964A (ja) 2024-03-12
IL236268B (en) 2022-03-01
HRP20221325T1 (hr) 2022-12-23
AU2018241128B2 (en) 2020-05-21
CA3118913C (en) 2024-04-30
SG10201605407TA (en) 2016-08-30
HUE060175T2 (hu) 2023-02-28
AU2018241128A1 (en) 2018-10-25
WO2013188847A1 (en) 2013-12-19
IL236268A0 (en) 2015-02-26
RS63822B1 (sr) 2023-01-31
SI2861223T1 (sl) 2023-01-31
MX2014015436A (es) 2015-07-14
HK1209361A1 (en) 2016-04-01
MX2021005317A (es) 2022-12-16
US20140171515A1 (en) 2014-06-19
PT2861223T (pt) 2022-11-07
BR112014031394A2 (pt) 2017-06-27
CN111388430A (zh) 2020-07-10
CN104684550A (zh) 2015-06-03
AU2013274003B2 (en) 2018-07-05
TWI590820B (zh) 2017-07-11
BR112014031394A8 (pt) 2021-11-03
WO2013188847A8 (en) 2015-02-05

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B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

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