HRP20210034T1 - Farmaceutski pripravci koji sadrže meloksikam i rizatriptan - Google Patents

Farmaceutski pripravci koji sadrže meloksikam i rizatriptan Download PDF

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Publication number
HRP20210034T1
HRP20210034T1 HRP20210034TT HRP20210034T HRP20210034T1 HR P20210034 T1 HRP20210034 T1 HR P20210034T1 HR P20210034T T HRP20210034T T HR P20210034TT HR P20210034 T HRP20210034 T HR P20210034T HR P20210034 T1 HRP20210034 T1 HR P20210034T1
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HR
Croatia
Prior art keywords
dosage form
solid dosage
meloxicam
sbeβcd
rizatriptan
Prior art date
Application number
HRP20210034TT
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English (en)
Inventor
Herriot TABUTEAU
Original Assignee
Axsome Therapeutics, 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 Axsome Therapeutics, Inc. filed Critical Axsome Therapeutics, Inc.
Publication of HRP20210034T1 publication Critical patent/HRP20210034T1/hr

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    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41961,2,4-Triazoles
    • 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
    • A61K31/54Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • 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
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (15)

1. Čvrsti oblik doziranja koji sadrži: inkluzijski kompleks od 5 mg do 50 mg meloksikama i 50 mg do 200 mg sulfobutil etera β-ciklodekstrina (SBEβCD); 400 mg do 1000 mg bikarbonata; i 5 mg do 50 mg rizatriptana; pri čemu je čvrsti oblik doziranja oralni oblik doziranja koji ima srednju vrijednost Tmax meloksikama kraću od 3 sata, što je kraće od referentnog oblika doziranja koji: 1) sadrži istu količinu meloksikama, 2) ne sadrži rizatriptan, 3) ne sadrži SBEβCD i 4) ne sadrži bikarbonat, kada se daje čovjeku.
2. Čvrsti oblik doziranja prema zahtjevu 1, koji sadrži inkluzijski kompleks 1) meloksikama ili triptana i 2) SBEβCD.
3. Čvrsti oblik doziranja prema zahtjevu 1 ili 2, sadrži 10 mg do 20 mg meloksikama.
4. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što SBEβCD ima 6 ili 7 sulfobutil eterskih skupina za svaku molekulu β-ciklodekstrina.
5. Čvrsti oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time što sadrži 80 mg do 120 mg SBEβCD.
6. Čvrsti oblik doziranja prema bilo kojem prethodnom zahtjevu, naznačen time što oblik doziranja sadrži 100 mg SBEβCD.
7. Čvrsti oblik doziranja prema patentnom zahtjevu 6, sadrži 8 mg do 13 mg rizatriptana.
8. Čvrsti oblik doziranja prema patentnom zahtjevu 6, naznačen time što bikarbonat sadrži natrij bikarbonat, a u obliku doziranja je od 400 mg do 600 mg natrij bikarbonata.
9. Čvrsti oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time što se pokazalo da oralni oblik doziranja ima srednju vrijednost Tmax meloksikama koja je manja od 2 sata kod čovjeka.
10. Čvrsti oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time što oralni oblik doziranja ima povećanu bioraspoloživost meloksikama u usporedbi s referentnim oblikom doziranja kada se daje čovjeku, i pri čemu se pokazalo da oralni oblik doziranja ima srednju Cmax meloksikama od 1600-2500 ng / ml.
11. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što se pokazalo da oralni oblik doziranja ima prosječni Tmax meloksikam od oko 1 sata, koji je kraći od referentnog oblika doziranja kada se daje čovjeku.
12. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što meloksikam i SBEβCD imaju molarni odnos od 0.8 do 1.2.
13. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što se koristi u liječenju boli kod čovjeka kojem je to potrebno.
14. Čvrsti oblik doziranja za uporabu prema zahtjevu 13, naznačen time što je bol migrena.
15. Čvrsti oblik doziranja za uporabu prema zahtjevu 13, naznačen time što je bol upalna bol.
HRP20210034TT 2017-01-04 2021-01-08 Farmaceutski pripravci koji sadrže meloksikam i rizatriptan HRP20210034T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762442136P 2017-01-04 2017-01-04
US201762504105P 2017-05-10 2017-05-10
US201762536466P 2017-07-25 2017-07-25
EP18736278.5A EP3565550B1 (en) 2017-01-04 2018-01-04 Pharmaceutical compositions comprising meloxicam and rizatriptan
PCT/US2018/012433 WO2018129220A1 (en) 2017-01-04 2018-01-04 Pharmaceutical compositions comprising meloxicam

Publications (1)

Publication Number Publication Date
HRP20210034T1 true HRP20210034T1 (hr) 2021-04-02

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HRP20210034TT HRP20210034T1 (hr) 2017-01-04 2021-01-08 Farmaceutski pripravci koji sadrže meloksikam i rizatriptan

Country Status (20)

Country Link
US (4) US10137131B2 (hr)
EP (2) EP3565550B1 (hr)
JP (3) JP6870867B2 (hr)
KR (4) KR20240013848A (hr)
CN (1) CN110621314A (hr)
AU (3) AU2018205790B2 (hr)
CA (2) CA3049229C (hr)
CO (1) CO2019008364A2 (hr)
CY (1) CY1123820T1 (hr)
DK (1) DK3565550T3 (hr)
ES (1) ES2845566T3 (hr)
HR (1) HRP20210034T1 (hr)
HU (1) HUE052749T2 (hr)
LT (1) LT3565550T (hr)
MX (2) MX2019008127A (hr)
PL (1) PL3565550T3 (hr)
PT (1) PT3565550T (hr)
RS (1) RS61346B1 (hr)
SI (1) SI3565550T1 (hr)
WO (1) WO2018129220A1 (hr)

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