HRP20240285T1 - Farmaceutski pripravci koji sadrže sorbitan estere - Google Patents

Farmaceutski pripravci koji sadrže sorbitan estere Download PDF

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Publication number
HRP20240285T1
HRP20240285T1 HRP20240285TT HRP20240285T HRP20240285T1 HR P20240285 T1 HRP20240285 T1 HR P20240285T1 HR P20240285T T HRP20240285T T HR P20240285TT HR P20240285 T HRP20240285 T HR P20240285T HR P20240285 T1 HRP20240285 T1 HR P20240285T1
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Croatia
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weight
preparation
percent
polysorbate
disorder
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HRP20240285TT
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English (en)
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Magali B. Hickey
Jason M. Perry
Daniel R. Deaver
Julius F. Remenar
Jennifer Vandiver
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Alkermes Pharma Ireland Limited
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Application filed by Alkermes Pharma Ireland Limited filed Critical Alkermes Pharma Ireland Limited
Publication of HRP20240285T1 publication Critical patent/HRP20240285T1/hr

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    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/38Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/381Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • 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
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965Non-condensed pyrazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965Non-condensed pyrazines
    • A61K31/497Non-condensed pyrazines containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic 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
    • A61K31/55131,4-Benzodiazepines, e.g. diazepam or clozapine

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (11)

1. Farmaceutski pripravak koji sadrži: (a) spoj A-7 [image] ili njegovu farmaceutski prihvatljivu sol, hidrat ili solvat; (b) sorbitan laurat; (c) polisorbat 20; i (d) vodeni vehikul; pri čemu je odnos komponente (b) prema (c) u opsegu od 3 prema 1 – 2 prema 1, težinski; i pri čemu pripravak formira vodenu, flokuliranu, suspenziju za injekciju.
2. Pripravak prema zahtjevu 1, koji sadrži ili oko 0.2 - 1 težinskih postotaka sorbitan laurata; oko 0.4 – 0.7 težinskih postotaka sorbitan laurata; ili oko 0.5 težinska postotka sorbitan laurata.
3. Pripravak prema zahtjevu 1, koja sadrži ili oko 0.05 – 0.8 težinskih postotaka polisorbata 20; oko 0.1 – 0.3 težinskih postotaka polisorbata 20, ili oko 0.2 težinska postotka polisorbata 20.
4. Pripravak prema bilo kom od prethodnih zahtjeva, koja sadrži približno 15 - 35 težinskih postotaka spoja A-7, ili njegove farmaceutski prihvatljive soli, hidrata ili solvata, ili približno 20 - 30 težinskih postotaka spoja A-7, ili njegove farmaceutski prihvatljive soli, hidrata ili solvata.
5. Farmaceutski pripravak za injekciju koji sadrži: (a) spoj A-7, ili njegove farmaceutski prihvatljive soli, hidrate ili solvate, [image] pri čemu je komponenta (a) u težinskom odnosu od približno 15 - 35%; (b) sorbitan laurat u težinskom odnosu od 0.2 - 1%; (c) polisorbat 20 u težinskom odnosu od 0.05 – 0.8%; i (d) vodeni nosač; gdje je odnos komponente (b) prema (c) u opsegu od 3 prema 1 – 2 prema 1, težinski.
6. Pripravak prema zahtjevu 5, gdje je pripravak formulirana za modulaciju reakcije tkiva povezane sa isporukom antipsihotičkog sredstva nerastopljivog u vodi, pri čemu modulacija reakcije tkiva predstavlja smanjenje iritacije na mjestu injekcije.
7. Pripravak prema bilo kojem od zahtjeva 1 do 6, pri čemu vodeni vehikul ili nosač sadrži pufer, gdje je pufer fosfat, citrat, tartarat, acetat ili fosfatno-puferirana fiziološka otopina.
8. Pripravak prema bilo kojem od zahtjeva 1 do 7, za uporabu u liječenju poremećaja centralnog nervnog sustava.
9. Pripravak za uporabu prema zahtjevu 8, pri čemu je poremećaj anksioznost ili depresija; ili gdje je poremećaj bipolarni poremećaj; ili gdje je poremećaj razdražljivost povezana sa autizmom.
10. Pripravak za uporabu prema zahtjevu 8, pri čemu je poremećaj psihotično stanje.
11. Pripravak za uporabu prema zahtjevu 10, pri čemu je psihotično stanje shizofrenija ili shizofreniformne bolesti; ili gdje je psihotično stanje akutna manija.
HRP20240285TT 2011-03-18 2012-03-19 Farmaceutski pripravci koji sadrže sorbitan estere HRP20240285T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161454008P 2011-03-18 2011-03-18
EP16185202.5A EP3156056B1 (en) 2011-03-18 2012-03-19 Pharmaceutical compositions comprising sorbitan esters

Publications (1)

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HRP20240285T1 true HRP20240285T1 (hr) 2024-05-24

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ID=45929620

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20240285TT HRP20240285T1 (hr) 2011-03-18 2012-03-19 Farmaceutski pripravci koji sadrže sorbitan estere
HRP20161549TT HRP20161549T1 (hr) 2011-03-18 2016-11-22 Injektabilni farmaceutski pripravci koji sadrže antipsihotik koji je netopljiv u vodi, sorbitan laurat i polisorbat 20

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Application Number Title Priority Date Filing Date
HRP20161549TT HRP20161549T1 (hr) 2011-03-18 2016-11-22 Injektabilni farmaceutski pripravci koji sadrže antipsihotik koji je netopljiv u vodi, sorbitan laurat i polisorbat 20

Country Status (23)

Country Link
US (7) US9034867B2 (hr)
EP (3) EP4327872A3 (hr)
JP (3) JP6138703B2 (hr)
CN (3) CN112451477B (hr)
AU (4) AU2012231160B2 (hr)
BR (1) BR112013023847B1 (hr)
CA (1) CA2830511C (hr)
CY (1) CY1118252T1 (hr)
DK (2) DK3156056T3 (hr)
ES (2) ES2972387T3 (hr)
FI (1) FI3156056T3 (hr)
HR (2) HRP20240285T1 (hr)
HU (2) HUE065359T2 (hr)
IL (4) IL296695B1 (hr)
LT (2) LT3156056T (hr)
MX (1) MX358344B (hr)
PL (2) PL3156056T3 (hr)
PT (2) PT3156056T (hr)
RS (2) RS65237B1 (hr)
RU (2) RU2627469C2 (hr)
SI (2) SI3156056T1 (hr)
SM (1) SMT201600423B (hr)
WO (1) WO2012129156A1 (hr)

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