HRP20211286T1 - Fine čestice epinefrina i metode njihove korištenja za liječenje stanja koja odgovaraju na epinefrin - Google Patents

Fine čestice epinefrina i metode njihove korištenja za liječenje stanja koja odgovaraju na epinefrin Download PDF

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Publication number
HRP20211286T1
HRP20211286T1 HRP20211286TT HRP20211286T HRP20211286T1 HR P20211286 T1 HRP20211286 T1 HR P20211286T1 HR P20211286T T HRP20211286T T HR P20211286TT HR P20211286 T HRP20211286 T HR P20211286T HR P20211286 T1 HRP20211286 T1 HR P20211286T1
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Prior art keywords
microcrystals
epinephrine bitartrate
pharmaceutical preparation
epinephrine
pharmaceutically effective
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HRP20211286TT
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English (en)
Inventor
Ousama Rachid
Keith Simons
Estelle Simons
Mutasem Rawas-Qalaji
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Nova Southeastern University
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Publication of HRP20211286T1 publication Critical patent/HRP20211286T1/hr

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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
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles

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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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)

Claims (15)

1. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži: farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i barem jedan od farmaceutski učinkovitih nosača, surfaktanta, pojačivača penetracije i mukoadheziva.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što farmaceutski učinkovita doza iznosi približno 10 mg ili približno 20 mg mikrokristala epinefrin bitartrata.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što nadalje sadrži najmanje jedno punilo, lubrikant, sredstvo za dezintegraciju, sredstvo za zaslađivanje i pojačivač osjećaja u ustima i pojačivač okusa; po mogućnosti gdje je zaslađivač i pojačivač osjećaja u ustima manitol, a pojačivač okusa limunska kiselina.
4. Farmaceutski pripravak prema zahtjevu 1, naznačen time, da sadrži: farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata, po mogućnosti približno 10 mg ili približno 20 mg mikrokristala epinefrin bitartrata; i mikrokristalnu celulozu, nisko supstituiranu hidroksipropil celuloza i magnezijev stearat.
5. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno - 4.5± 1.4 mV.
6. Farmaceutski pripravak prema zahtjevu 1, naznačen time, da sadrži: farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata, po mogućnosti približno 10 mg ili približno 20 mg mikrokristala epinefrina bitartrata; mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno - 4.5± 1.4 mV; i mikrokristalna celuloza, nisko supstituirana hidroksipropil celuloza i magnezijev stearat.
7. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži: farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i najmanje jedan od farmaceutski prihvatljivih nosača, surfaktanta, pojačivača penetracije i mukoadheziva; pri čemu je pripravak namijenjen upotrebi u metodi za povećanje sublingvalne bioraspoloživosti epinefrina kod subjekta kojem je to potrebno.
8. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži: farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i najmanje jedan od farmaceutski prihvatljivih nosača, surfaktanta, pojačivača penetracije i mukoadheziva; pri čemu je pripravak namijenjen upotrebi u metodi za liječenje stanja koje reagira na epinefrin kod subjekta kojem je to potrebno.
9. Farmaceutski pripravak za uporabu prema zahtjevu 8, naznačen time da je stanje koje reagira na epinefrin alergijska reakcija.
10. Farmaceutski pripravak za uporabu prema zahtjevu 9, naznačen time, da je alergijska reakcija anafilaksija, astma ili bronhijalna astma.
11. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži: farmaceutski učinkovita doza od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i najmanje jedan od farmaceutski prihvatljivih nosača, surfaktanta, pojačivača penetracije i mukoadheziva; pri čemu je pripravak namijenjen upotrebi u metodi za liječenje poteškoća s disanjem kod subjekta kojem je to potrebno; ili liječenje hitne alergijske bolesti kod subjekta kojem je dijagnosticirana ili se sumnja da ima alergijski hitni slučaj.
12. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 11, naznačen time što su poteškoće s disanjem povezane s anafilaksijom, astmom, bronhijalnom astmom, bronhitisom, emfizemom ili respiratornom infekcijom; ili hitna alergijska situacija je anafilaksija, astma ili bronhijalna astma.
13. Farmaceutski pripravak za uporabu prema zahtjevu 7, 8 ili 11, naznačen time, da farmaceutski učinkovita doza iznosi približno 10 mg ili približno 20 mg mikrokristala epinefrin bitartrata.
14. Farmaceutski pripravak za uporabu prema zahtjevu 7, 8 ili 11, naznačen time, da mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno - 4.5± 1.4 mV.
15. Farmaceutski pripravak za uporabu prema zahtjevu 7, 8 ili 11, naznačen time, da sadrži: farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata, po mogućnosti približno 10 mg ili približno 20 mg mikrokristala epinefrina bitartrata; pri čemu mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno -4.5± 1.4 mV; i mikrokristalnu celulozu, nisko supstituiranu hidroksipropil celulozu i magnezijev stearat.
HRP20211286TT 2013-03-22 2014-03-24 Fine čestice epinefrina i metode njihove korištenja za liječenje stanja koja odgovaraju na epinefrin HRP20211286T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361804519P 2013-03-22 2013-03-22
US201361804892P 2013-03-25 2013-03-25
PCT/US2014/031579 WO2014153559A1 (en) 2013-03-22 2014-03-24 Epinephrine fine particles and methods for use thereof for treatment of conditions responsive to epinephrine
EP14768584.6A EP2976072B9 (en) 2013-03-22 2014-03-24 Epinephrine fine particles and methods for use thereof for treatment of conditions responsive to epinephrine

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US (2) US11229613B2 (hr)
EP (2) EP3888642A1 (hr)
CA (1) CA2907770C (hr)
DK (1) DK2976072T3 (hr)
ES (1) ES2882530T3 (hr)
HR (1) HRP20211286T1 (hr)
HU (1) HUE055773T2 (hr)
PL (1) PL2976072T3 (hr)
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PL2976072T3 (pl) 2021-11-22
WO2014153559A1 (en) 2014-09-25
EP2976072A1 (en) 2016-01-27
HUE055773T2 (hu) 2021-12-28
DK2976072T3 (da) 2021-08-16
EP2976072A4 (en) 2016-09-07
CA2907770A1 (en) 2014-09-25
ES2882530T3 (es) 2021-12-02
EP2976072B9 (en) 2021-10-13
EP2976072B1 (en) 2021-05-12
US20220218629A1 (en) 2022-07-14
PT2976072T (pt) 2021-08-12
US11229613B2 (en) 2022-01-25
EP3888642A1 (en) 2021-10-06
CA2907770C (en) 2022-02-15
US20190125698A1 (en) 2019-05-02

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