HRP20191805T1 - Postupci za liječenje netuberkuloznih mikobakterijskih infekcija pluća - Google Patents

Postupci za liječenje netuberkuloznih mikobakterijskih infekcija pluća Download PDF

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Publication number
HRP20191805T1
HRP20191805T1 HRP20191805TT HRP20191805T HRP20191805T1 HR P20191805 T1 HRP20191805 T1 HR P20191805T1 HR P20191805T T HRP20191805T T HR P20191805TT HR P20191805 T HRP20191805 T HR P20191805T HR P20191805 T1 HRP20191805 T1 HR P20191805T1
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Croatia
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pharmaceutical preparation
patient
use according
amikacin
period
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HRP20191805TT
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English (en)
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Gina EAGLE
Renu Gupta
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Insmed Incorporated
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Publication of HRP20191805T1 publication Critical patent/HRP20191805T1/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
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/7036Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/133Amines having hydroxy groups, e.g. sphingosine
    • 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/438The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4709Non-condensed quinolines and 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
    • A61K31/495Heterocyclic 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
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53831,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/542Heterocyclic 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 heterocyclic ring systems
    • A61K31/545Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/65Tetracyclines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • 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
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • 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
    • A61K9/127Liposomes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dispersion Chemistry (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)

Claims (14)

1. Farmaceutski pripravak koji sadrži od 450 mg do 650 mg amikacina, ili njegove farmaceutski prihvatljive soli, ugrađenog u mnoštvu liposoma, gdje se lipidna komponenta mnoštva liposoma sastoji od dipalmitoilfosfatidilholina (DPPC) i kolesterola, namijenjena liječenju ili osiguravanju profilakse protiv infekcije pluća izazvane Mycobacterium avium kompleksom (MAC) kod pacijenta kome je potrebno liječenje ili profilaksa, pri čemu se pripravak primjenjuje jednom dnevno u jednom doziranju, tokom perioda primijene od najmanje tri mjeseca, na pluća pacijenta aerosolizacijom farmaceutskog pripravka putem raspršivača da bi se osigurao aerosolizirani farmaceutski pripravak koji sadrži mješavinu slobodnog amikacina, ili njegove farmaceutski prihvatljive soli i liposomalno kompleksnog amikacina, ili njegove farmaceutski prihvatljive soli, pri čemu tokom perioda primijene ili nakon perioda primijene, kod pacijenta dolazi do konverzije kulture MAC u negativnu.
2. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 1, naznačen time, što tokom perioda primijene ili nakon perioda primijene, pacijent ostvaruje povećani broj prijeđenih metara u 6-minutnom testu hodanja (6MWT), u usporedbi sa brojem metara koje je pacijent prešao prije podvrgavanja postupku liječenja.
3. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 1 ili 2, naznačen time, što kod pacijenta dolazi do poboljšanja volumena prisilnog izdisanja u jednoj sekundi (FEV1) tokom najmanje 15 dana nakon završetka perioda primijene, u usporedbi sa FEV1 pacijenta prije liječenja.
4. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-3, naznačen time, što je amikacin ili njegova farmaceutski prihvatljiva sol amikacin sulfat.
5. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 4, naznačen time, što liposom sadrži jednolamelarne vezikule, višelamelarne vezikule, ili njihovu mješavinu.
6. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, što je volumen farmaceutskog pripravka koji je primijenjen kod pacijenta od oko 8 mL do oko 10 mL.
7. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, što se tokom jednog doziranja, aerosolizirani farmaceutski pripravak primjenjuje za manje od oko 15 minuta, manje od oko 14 minuta, manje od oko 13 minuta, manje od oko 12 minuta, ili manje od oko 11 minuta.
8. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-7, naznačen time, što pacijent kome je potrebno liječenje ili profilaksa prethodno nije odgovarao na terapiju protiv MAC.
9. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-8, naznačen time, što je povećani broj uspoređenih metara u testu 6MWT najmanje oko 5 metara.
10. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-9, naznačen time, što poboljšanje FEV1 pacijenta iznosi najmanje 5% u odnosu na FEV1 pacijenta prije liječenja.
11. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-10, naznačen time, što farmaceutski pripravak sadrži od oko 550 mg do oko 625 mg amikacina, ili njegove farmaceutski prihvatljive soli.
12. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 11, naznačen time, što farmaceutski pripravak sadrži od oko 550 mg do oko 600 mg amikacina, ili njegove farmaceutski prihvatljive soli.
13. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-12, naznačen time, što kod pacijenta dolazi do poboljšanja zasićenosti krvi kisikom tokom najmanje 15 dana nakon završetka perioda primijene, u usporedbi sa zasićenošću krvi kisikom kod pacijenta prije perioda primijene.
14. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-13, naznačen time, što je period primijene najmanje oko 6 mjeseci.
HRP20191805TT 2014-05-15 2019-10-03 Postupci za liječenje netuberkuloznih mikobakterijskih infekcija pluća HRP20191805T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201461993439P 2014-05-15 2014-05-15
US201462042126P 2014-08-26 2014-08-26
US201462048068P 2014-09-09 2014-09-09
US201462056296P 2014-09-26 2014-09-26
PCT/US2015/031079 WO2015175939A1 (en) 2014-05-15 2015-05-15 Methods for treating pulmonary non-tuberculous mycobacterial infections
EP15791964.8A EP3142643B1 (en) 2014-05-15 2015-05-15 Methods for treating pulmonary non-tuberculous mycobacterial infections

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HRP20191805T1 true HRP20191805T1 (hr) 2019-12-27

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US (13) US10238675B2 (hr)
EP (4) EP3766501B1 (hr)
JP (4) JP6646653B2 (hr)
KR (4) KR102447412B1 (hr)
CN (1) CN106535877A (hr)
AU (2) AU2015258947B2 (hr)
BR (1) BR112016026699B1 (hr)
CA (1) CA2949078C (hr)
CY (2) CY1122129T1 (hr)
DK (2) DK3142643T3 (hr)
ES (3) ES2755941T3 (hr)
HR (1) HRP20191805T1 (hr)
HU (1) HUE051440T2 (hr)
LT (2) LT3466432T (hr)
ME (1) ME03536B (hr)
MX (2) MX2016014921A (hr)
NZ (1) NZ726256A (hr)
PL (2) PL3142643T3 (hr)
PT (2) PT3142643T (hr)
RS (1) RS60827B1 (hr)
SI (2) SI3142643T1 (hr)
WO (1) WO2015175939A1 (hr)

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RS60827B1 (sr) 2020-10-30
US20180185401A1 (en) 2018-07-05
KR20170005104A (ko) 2017-01-11
EP3142643A1 (en) 2017-03-22
BR112016026699B1 (pt) 2022-09-13
US20170360816A1 (en) 2017-12-21
US20190160086A1 (en) 2019-05-30
US10751355B2 (en) 2020-08-25
EP4122470B1 (en) 2024-03-20
CN106535877A (zh) 2017-03-22
WO2015175939A1 (en) 2015-11-19
JP2017515913A (ja) 2017-06-15
AU2015258947B2 (en) 2020-04-09
PT3142643T (pt) 2019-10-28
KR20230015496A (ko) 2023-01-31
EP3466432A1 (en) 2019-04-10
US10588918B2 (en) 2020-03-17
US20230037417A1 (en) 2023-02-09
US20230330119A1 (en) 2023-10-19
US20180311267A1 (en) 2018-11-01
PT3466432T (pt) 2020-10-08
ES2755941T3 (es) 2020-04-24

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