DK2720699T3 - Administration af benzodiazepin - Google Patents

Administration af benzodiazepin Download PDF

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Publication number
DK2720699T3
DK2720699T3 DK12801372.9T DK12801372T DK2720699T3 DK 2720699 T3 DK2720699 T3 DK 2720699T3 DK 12801372 T DK12801372 T DK 12801372T DK 2720699 T3 DK2720699 T3 DK 2720699T3
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DK
Denmark
Prior art keywords
seizure
benzodiazepine
diazepam
drug
administration
Prior art date
Application number
DK12801372.9T
Other languages
English (en)
Inventor
Steve Cartt
David Medeiros
Garry Thomas Gwozdz
Andrew Loxley
Mark Mitchnick
David Hale
Edward T Maggio
Original Assignee
Hale Biopharma Ventures Llc
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Publication of DK2720699T3 publication Critical patent/DK2720699T3/da

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    • 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
    • A61K9/0043—Nose
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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

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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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Pulmonology (AREA)
  • Dispersion Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (13)

1. Farmaceutisk opløsning til anvendelse i en fremgangsmåde til behandling af anfald med nasal administration af nævnte farmaceutiske opløsning, som består af: (a) et benzodiazepinstof; (b) et eller flere naturlige eller syntetiske tocopheroler eller tocotrienoler, eller en hvilken som helst kombination deraf, i en mængde fra 30 % til 95 % (vægt/vægt); (c) 1-25 % (vægt/volumen) ethanol og 1-25 % (vægt/volumen) benzylalkohol, i en kombineret mængde fra 10 % til 50 % (vægt/vægt); (d) et alkylglycosid; og (e) eventuelt mindst en yderligere aktiv farmaceutisk ingrediens eller excipiens.
2. Den farmaceutiske opløsning til anvendelse ifølge krav 1, hvor benzodiazepinstoffet er valgt fra gruppen bestående af: alprazolam, brotizolam, chlordiazepoxid, clobazam, clonazepam, clorazepam, demoxazepam, diazepam, flumazenil, flurazepam, halazepam, midazolam, nordazepam, medazepam, nitrazepam, oxazepam, lorazepam, prazepam, quazepam, triazolam, temazepam, loprazolam, hvilke som helst farmaceutisk acceptable salte deraf, og en hvilken som helst kombination deraf.
3. Den farmaceutiske opløsning til anvendelse ifølge krav 2, som indeholder 1 til 20 % (vægt/volumen) af benzodiazepin.
4. Den farmaceutiske opløsning til anvendelse ifølge krav 3, som indeholder 1 til 20 % (vægt/volumen) af diazepam.
5. Den farmaceutiske opløsning til anvendelse ifølge krav 1, hvor det ene eller flere naturlige eller syntetiske tocopheroler eller tocotrienoler er valgt fra gruppen bestående af: a-tocopherol, β-tocopherol, y-tocopherol, δ-tocopherol, a- tocotrienol, β- tocotrienol, γ-tocotrienol, δ- tocotrienol, tocophersolan, hvilke som helst isomerer deraf, hvilke som helst estere deraf, hvilke som helst analoger deraf, og en hvilken som helst kombination deraf.
6. Den farmaceutiske opløsning til anvendelse ifølge krav 1, som indeholder 10-22,5 % (vægt/volumen) ethanol og 7,5-12,5 % (vægt/volumen) benzylalkohol.
7. Den farmaceutiske opløsning til anvendelse ifølge krav 1, hvor det ene eller flere naturlige eller syntetiske tocopheroler eller tocotrienoler, eller en hvilken som helst kombination deraf, er i en mængde fra 45 % til 85 % (vægt/vægt).
8. Den farmaceutiske opløsning til anvendelse ifølge krav 1, som består af 5-15 % (vægt/volumen) diazepam, 0,01-1 % (vægt/volumen) alkylglycosid, 45-65 % (vægt/volumen) vitamin E, 10-25 % (vægt/volumen) ethanol og 5-15 % (vægt/volumen) benzylalkohol.
9. Den farmaceutiske opløsning til anvendelse ifølge krav 1, hvor den farmaceutisk acceptable formulering omfatter mindst 0,01 % (vægt/vægt) af et alkylglycosid.
10. Den farmaceutiske opløsning til anvendelse ifølge krav 9, hvor den farmaceutisk acceptable formulering omfatter 0,01 % til 1 % (vægt/vægt) af dodecylmaltosid.
11. Den farmaceutiske opløsning til anvendelse ifølge krav 1, som består af diazepam, vitamin E, ethanol, benzylalkohol, og dodecylmaltosid.
12. Den farmaceutiske opløsning til anvendelse ifølge krav 1, som består af 5-15 % (vægt/volumen) diazepam, 45-65 % (vægt/volumen) vitamin E, 10-25 % (vægt/volumen) ethanol, 5-15 % (vægt/volumen) benzylalkohol, og 0,01-1 % (vægt/volumen) dodecylmaltosid.
13. Den farmaceutiske opløsning til anvendelse ifølge krav 1, som består af 10 % (vægt/volumen) diazepam, 56,47 % (vægt/volumen) vitamin E, q.s. vandfri ethanol, 10,5 % (vægt/volumen) benzylalkohol, og 0,25 % (vægt/volumen) dodecylmaltosid.
DK12801372.9T 2011-06-14 2012-06-13 Administration af benzodiazepin DK2720699T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161497017P 2011-06-14 2011-06-14
US201161570110P 2011-12-13 2011-12-13
PCT/US2012/042311 WO2012174158A2 (en) 2011-06-14 2012-06-13 Administration of benzodiazepine

Publications (1)

Publication Number Publication Date
DK2720699T3 true DK2720699T3 (da) 2018-08-20

Family

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DK12801372.9T DK2720699T3 (da) 2011-06-14 2012-06-13 Administration af benzodiazepin
DK18171484.1T DK3415139T3 (da) 2011-06-14 2012-06-13 Administration af benzodiazepin

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Country Status (10)

Country Link
US (5) US8895546B2 (da)
EP (3) EP3415139B8 (da)
JP (4) JP6219272B2 (da)
CN (2) CN107737100A (da)
DK (2) DK2720699T3 (da)
ES (2) ES2917973T3 (da)
HK (1) HK1250647A1 (da)
PL (1) PL3415139T3 (da)
PT (1) PT3415139T (da)
WO (1) WO2012174158A2 (da)

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