HRP20221325T1 - Pripravci i postupci transmukozne apsorpcije - Google Patents

Pripravci i postupci transmukozne apsorpcije Download PDF

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Publication number
HRP20221325T1
HRP20221325T1 HRP20221325TT HRP20221325T HRP20221325T1 HR P20221325 T1 HRP20221325 T1 HR P20221325T1 HR P20221325T T HRP20221325T T HR P20221325TT HR P20221325 T HRP20221325 T HR P20221325T HR P20221325 T1 HRP20221325 T1 HR P20221325T1
Authority
HR
Croatia
Prior art keywords
preparation according
sublingual
phosphate
disease
condition
Prior art date
Application number
HRP20221325TT
Other languages
English (en)
Inventor
Harry Brittain
Seth Lederman
Giorgio Reiner
Original Assignee
Tonix Pharma Holdings Limited
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 Limited filed Critical Tonix Pharma Holdings Limited
Publication of HRP20221325T1 publication Critical patent/HRP20221325T1/hr

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Classifications

    • 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

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)

Claims (9)

1. Pripravak prikladan za oralnu transmukoznu apsorpciju koji sadrži farmaceutski prihvatljivu sol ciklobenzaprina i sredstvo za baziranje.
2. Pripravak prema zahtjevu 1, naznačen time što je oralna transmukozna apsorpcija sublingvalna apsorpcija.
3. Pripravak prema zahtjevu 2, naznačen time što je pripravak u obliku odabranom iz skupine koju čine sublingvalna tableta, sublingvalni film, sublingvalni prašak, i sublingvalna otopina za raspršivanje.
4. Pripravak prema bilo kojem od zahtjeva 1 do 3, naznačen time što je farmaceutski prihvatljiva sol ciklobenzaprina ciklobenzaprin HCl.
5. Pripravak prema bilo kojem od zahtjeva 1 do 4, naznačen time što je sredstvo za baziranje odabrano iz skupine koju čine kalijev dihidrogen fosfat, dikalijev hidrogen fosfat, trikalijev fosfat, natrijev karbonat, natrijev bikarbonat, kalcijev karbonat, kalcijev bikarbonat, TRIS pufer, natrijev dihidrogen fosfat, dinatrijev hidrogen fosfat, trinatrijev fosfat, kalijev karbonat, kalijev bikarbonat, kalijev acetat, natrijev acetat, dikalijev citrat, trikalijev citrat, dinatrijev citrat i trinatrijev citrat.
6. Pripravak prema zahtjevu 5, naznačen time što je sredstvo za baziranje dikalijev hidrogen fosfat.
7. Pripravak prema zahtjevu 5, naznačen time što je sredstvo za baziranje kalijev dihidrogen fosfat.
8. Pripravak prema bilo kojem od zahtjeva 1 do 7 za uporabu u postupku za liječenje bolesti ili stanja kod pojedinca, pri čemu postupak uključuje davanje navedenog pripravka transmukoznom apsorpcijom, pri čemu je bolest ili stanje posttraumatski stresni poremećaj (PTSP).
9. Pripravak prema bilo kojem od zahtjeva 1 do 7 za uporabu u postupku za liječenje bolesti ili stanja kod pojedinca, pri čemu postupak uključuje davanje navedenog pripravka transmukoznom apsorpcijom, pri čemu je bolest ili stanje odabrano iz skupine koju čine fibromijalgija, depresija, traumatska ozljeda mozga, poremećaj spavanja, san koji se ne obnavlja, kronična bol, spazam mišića, i anksiozni poremećaj.
HRP20221325TT 2012-06-15 2013-06-14 Pripravci i postupci transmukozne apsorpcije HRP20221325T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201261660593P 2012-06-15 2012-06-15
US201261667774P 2012-07-03 2012-07-03
US201261725402P 2012-11-12 2012-11-12
US201361792900P 2013-03-15 2013-03-15
PCT/US2013/046023 WO2013188847A1 (en) 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption
EP13804115.7A EP2861223B1 (en) 2012-06-15 2013-06-14 Compositions and methods for transmucosal absorption

Publications (1)

Publication Number Publication Date
HRP20221325T1 true HRP20221325T1 (hr) 2022-12-23

Family

ID=49758769

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20221325TT HRP20221325T1 (hr) 2012-06-15 2013-06-14 Pripravci i postupci transmukozne apsorpcije

Country Status (26)

Country Link
US (1) US20140171515A1 (hr)
EP (1) EP2861223B1 (hr)
JP (5) JP6259452B2 (hr)
CN (2) CN111388430A (hr)
AR (1) AR092330A1 (hr)
AU (2) AU2013274003B2 (hr)
BR (1) BR112014031394B1 (hr)
CA (2) CA2876902C (hr)
DK (1) DK2861223T3 (hr)
ES (1) ES2929133T3 (hr)
HK (1) HK1209361A1 (hr)
HR (1) HRP20221325T1 (hr)
HU (1) HUE060175T2 (hr)
IL (1) IL236268B (hr)
LT (1) LT2861223T (hr)
MX (2) MX2021005317A (hr)
MY (1) MY194495A (hr)
NZ (2) NZ631144A (hr)
PL (1) PL2861223T3 (hr)
PT (1) PT2861223T (hr)
RS (1) RS63822B1 (hr)
SG (2) SG11201408318RA (hr)
SI (1) SI2861223T1 (hr)
TW (3) TWI683660B (hr)
WO (1) WO2013188847A1 (hr)
ZA (1) ZA201500288B (hr)

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PL2501234T3 (pl) 2009-11-20 2018-01-31 Tonix Pharma Holdings Ltd Sposoby i kompozycje stosowane w leczeniu dolegliwości związanych z zespołem stresu pourazowego z użyciem cyklobenzapryny
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
DK2968992T3 (da) 2013-03-15 2020-02-03 Tonix Pharma Holdings Ltd Eutetiske formuleringer af cyclobenzaprinhydrochlorid og mannitol
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WO2018045367A1 (en) * 2016-09-02 2018-03-08 Nova Southeastern University Atropine sulfate rapidly-disintegrating sublingual tablets for treatment of acute organophosphate toxicity
CA3069699A1 (en) * 2017-07-13 2019-01-17 Tonix Pharmaceuticals Holding Corp. Analogs of cyclobenzaprine and amitryptilene
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
ES2930376T3 (es) * 2017-12-08 2022-12-09 Hoffmann La Roche Formulación farmacéutica
SG11202004799TA (en) 2017-12-11 2020-06-29 Tonix Pharma Holdings Ltd 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
MX2021002012A (es) 2018-08-20 2021-04-28 Tonix Pharma Holdings Ltd Metodos de tratamiento del trastorno por estres agudo y trastorno por estres postraumatico.
CA3156118A1 (en) * 2019-09-30 2021-04-08 Cadila Healthcare Limited INTRANASAL PHARMACEUTICAL COMPOSITIONS OF CYCLOBENZAPRINE
JP2023521167A (ja) * 2020-04-08 2023-05-23 トニックス ファーマシューティカルズ ホールディング コーポレーション 性機能障害のシクロベンザプリン処置
EP4247370A1 (en) * 2020-11-20 2023-09-27 Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine treatment for alcohol use disorder
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
WO2023059728A1 (en) 2021-10-06 2023-04-13 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)

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Also Published As

Publication number Publication date
JP2015519404A (ja) 2015-07-09
NZ631144A (en) 2016-12-23
WO2013188847A1 (en) 2013-12-19
DK2861223T3 (da) 2022-11-07
IL236268B (en) 2022-03-01
NZ726488A (en) 2018-10-26
AU2013274003A1 (en) 2015-02-05
JP6259452B2 (ja) 2018-01-10
TW201842903A (zh) 2018-12-16
CA3118913A1 (en) 2013-12-19
BR112014031394A8 (pt) 2021-11-03
BR112014031394A2 (pt) 2017-06-27
AU2018241128B2 (en) 2020-05-21
TWI683660B (zh) 2020-02-01
US20140171515A1 (en) 2014-06-19
MY194495A (en) 2022-11-30
AR092330A1 (es) 2015-04-15
LT2861223T (lt) 2022-12-12
PT2861223T (pt) 2022-11-07
CA2876902C (en) 2021-07-13
TW201408281A (zh) 2014-03-01
AU2013274003B2 (en) 2018-07-05
MX2014015436A (es) 2015-07-14
JP2021138765A (ja) 2021-09-16
ES2929133T3 (es) 2022-11-25
CN111388430A (zh) 2020-07-10
SG11201408318RA (en) 2015-01-29
TWI590820B (zh) 2017-07-11
TW201731494A (zh) 2017-09-16
CA3118913C (en) 2024-04-30
AU2018241128A1 (en) 2018-10-25
SI2861223T1 (sl) 2023-01-31
JP2019123757A (ja) 2019-07-25
CN104684550A (zh) 2015-06-03
IL236268A0 (en) 2015-02-26
EP2861223B1 (en) 2022-08-03
MX2021005317A (es) 2022-12-16
HUE060175T2 (hu) 2023-02-28
PL2861223T3 (pl) 2022-12-12
EP2861223A1 (en) 2015-04-22
HK1209361A1 (en) 2016-04-01
JP2017222726A (ja) 2017-12-21
JP2024032964A (ja) 2024-03-12
TWI642429B (zh) 2018-12-01
EP2861223A4 (en) 2016-01-27
ZA201500288B (en) 2022-05-25
CA2876902A1 (en) 2013-12-19
WO2013188847A8 (en) 2015-02-05
SG10201605407TA (en) 2016-08-30
RS63822B1 (sr) 2023-01-31
BR112014031394B1 (pt) 2022-10-18

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