HRP20151214T4 - Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti - Google Patents

Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti Download PDF

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Publication number
HRP20151214T4
HRP20151214T4 HRP20151214TT HRP20151214T HRP20151214T4 HR P20151214 T4 HRP20151214 T4 HR P20151214T4 HR P20151214T T HRP20151214T T HR P20151214TT HR P20151214 T HRP20151214 T HR P20151214T HR P20151214 T4 HRP20151214 T4 HR P20151214T4
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HR
Croatia
Prior art keywords
aclidinium
pharmaceutical composition
pharmaceutically acceptable
acceptable salt
use according
Prior art date
Application number
HRP20151214TT
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English (en)
Inventor
Rosa Lamarca Casado
Gonzalo De Miquel Serra
Original Assignee
Almirall, S.A.
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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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39645012&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20151214(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Almirall, S.A. filed Critical Almirall, S.A.
Publication of HRP20151214T1 publication Critical patent/HRP20151214T1/hr
Publication of HRP20151214T4 publication Critical patent/HRP20151214T4/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
    • A61K31/33Heterocyclic 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
    • A61K31/468-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K31/439Heterocyclic 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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • 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
    • 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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (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)

Claims (13)

1. Farmaceutski sastav koji sadrži aklidinij u obliku suhog praha farmaceutski prihvatljive soli u mješavini s farmaceutski prihvatljivim nosačem suhog praha, omogućava izmjerenu nominalnu dozu ekvivalenta aklidiniju do 400 µg (plus/minus 10%) aklidinij bromida za upotrebu udisanjem kod liječenja kronične opstruktivne bolesti pluća.
2. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 1, u obliku jednodozne formulacije suhog praha koja sadrži jednu izmjerenu nominalnu dozu aklidinija ekvivalentnu 400 mikrograma (plus/minus 10%) aklidinij bromida.
3. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 1, u obliku višedozne formulacije suhog praha za primjenu u višedoznom uređaju za inhalaciju suhog praha kalibriranom da osigura izmjerenu nominalnu dozu aklidinija koja je jednaka 400 mikrograma (plus/minus 10%) aklidinij bromida.
4. Farmaceutski sastav za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva gdje (a) farmaceutski prihvatljiva sol aklidinija je aklidinij bromid, i/ili (b) farmaceutski prihvatliv nosač su čestice laktoze.
5. Farmaceutski sastav za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, gdje je odnos težine aklidinija prema nosaču od 1:25 do 1:75.
6. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 5, gdje je odnos težine aklidinija prema nosaču od 1:50 do 1:75.
7. Farmaceutski sastav za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, gdje farmaceutski sastav još sadrži djelotvornu količinu jednog ili više dodatnih aktivnih agenasa izabranih iz β2-agonista, PDE IV inhibitora, i kortikosteroida.
8. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 7 gdje se dodatni aktivni agens bira iz: (i) formoterola, salmeterola i budesonida, u slobodnom ili u obliku farmaceutski prihvatljive soli, i (ii) flutikazon propionata.
9. Aklidinij u obliku farmaceutski prihvatljive soli za upotrebu u liječenju kronične opstruktivne bolesti pluća kod pacijenta kome je potrebno takvo liječenje, spomenuta upotreba obuhvaća primjenu udisanjem jednom ili dvaput dnevno izmjerene nominalne doze aklidinija koja odgovara količini od 400 µg (plus/minus 10%) aklidinij bromida, u obliku farmaceutskog sastava prema bilo kojem patentnom zahtjevu 1 do 8.
10. Aklidinij u obliku farmaceutski prihvatljive soli za upotrebu prema patentnom zahtjevu 9, spomenuta upotreba još sadrži primjenu djelotvorne količine jednog ili više aktivnih agenasa koji se biraju iz grupe β2-agonista, PDE IV inhibitora i kortikosteroida.
11. Aklidinij u obliku farmaceutski prihvatljive soli za upotrebu prema patentnom zahtjevu 10, gdje se dodatni aktivni agens bira iz: (i) formoterola, salmeterola, i budesonida, u slobodnom obliku ili u obliku farmaceutski prihvatljive soli, i (ii) flutikazon propionata.
12. Upotreba aklidinija u obliku farmaceutski prihvatljive soli za proizvodnju lijeka za liječenje kronične opstruktivne bolesti pluća kod pacijenta kome je potrebno takvo liječenje, spomenuta upotreba obuhvaća primjenu udisanjem jednom ili dvaput dnevno izmjerene nominalne doze aklidinijuma koja odgovara količini od 400 µg (plus/minus 10%) aklidinim bromida, u obliku farmaceutskog sastava prema bilo kojem patentnom zahtjevu 1 do 8.
13. Uređaj za udisanje suhog praha u vidu više doza sadrži aklidinijm, koji se kalibrira da isporuči, poslije aktiviranja, izmjerenu nominalnu dozu aklidinija ekvivalentnu količini 400 mikrograma (plus/minus 10%) aklidinij bromida.
HRP20151214TT 2008-03-13 2009-03-13 Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti HRP20151214T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08382010A EP2100599A1 (en) 2008-03-13 2008-03-13 Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease
EP09719213.2A EP2265257B2 (en) 2008-03-13 2009-03-13 Inhalation composition containing aclidinium for treatment of chronic obstructive pulmonary disease
PCT/EP2009/001832 WO2009112274A2 (en) 2008-03-13 2009-03-13 Novel dosage and formulation

Publications (2)

Publication Number Publication Date
HRP20151214T1 HRP20151214T1 (hr) 2015-12-18
HRP20151214T4 true HRP20151214T4 (hr) 2024-01-05

Family

ID=39645012

Family Applications (3)

Application Number Title Priority Date Filing Date
HRP20220929TT HRP20220929T3 (hr) 2008-03-13 2009-03-13 Sastav za inhalaciju koji sadrži aklidinij za liječenje astme
HRP20220919TT HRP20220919T3 (hr) 2008-03-13 2009-03-13 Sastav za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne bolesti pluća
HRP20151214TT HRP20151214T4 (hr) 2008-03-13 2009-03-13 Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti

Family Applications Before (2)

Application Number Title Priority Date Filing Date
HRP20220929TT HRP20220929T3 (hr) 2008-03-13 2009-03-13 Sastav za inhalaciju koji sadrži aklidinij za liječenje astme
HRP20220919TT HRP20220919T3 (hr) 2008-03-13 2009-03-13 Sastav za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne bolesti pluća

Country Status (37)

Country Link
US (3) US20110020412A1 (hr)
EP (5) EP2100599A1 (hr)
JP (3) JP2011513451A (hr)
KR (3) KR20180125055A (hr)
CN (2) CN102083416A (hr)
AR (1) AR070835A1 (hr)
AU (1) AU2009224895B9 (hr)
BR (1) BRPI0905775B1 (hr)
CA (1) CA2716724C (hr)
CL (1) CL2009000602A1 (hr)
CO (1) CO6290636A2 (hr)
CY (1) CY1116926T1 (hr)
DK (3) DK2265257T4 (hr)
EC (1) ECSP10010300A (hr)
ES (3) ES2551307T5 (hr)
FI (1) FI2265257T4 (hr)
HK (1) HK1145815A1 (hr)
HR (3) HRP20220929T3 (hr)
HU (3) HUE027726T2 (hr)
IL (3) IL206354A0 (hr)
LT (2) LT2954891T (hr)
ME (1) ME02286B (hr)
MX (2) MX2010008235A (hr)
MY (1) MY177027A (hr)
NZ (1) NZ585857A (hr)
PE (3) PE20190406A1 (hr)
PL (3) PL2954889T3 (hr)
PT (3) PT2954889T (hr)
RS (3) RS54241B2 (hr)
RU (3) RU2608713C3 (hr)
SG (1) SG188825A1 (hr)
SI (3) SI2954891T1 (hr)
TW (1) TWI439296B (hr)
UA (1) UA101652C2 (hr)
UY (1) UY31687A1 (hr)
WO (1) WO2009112274A2 (hr)
ZA (1) ZA201003900B (hr)

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EP2666465A1 (en) * 2012-05-25 2013-11-27 Almirall, S.A. Novel dosage and formulation
EA201590019A1 (ru) * 2012-07-05 2015-09-30 Арвен Айлак Санайи Ве Тиджарет А.С. Ингаляторы сухого порошка, содержащие носитель, отличный от лактозы
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US10111957B2 (en) 2012-07-05 2018-10-30 Arven Ilac Snayi ve Ticaret A.S. Inhalation compositions comprising glucose anhydrous
ES2917879T3 (es) * 2012-12-17 2022-07-12 Almirall Sa Nuevo uso de aclidinio
AU2014261539A1 (en) * 2013-04-29 2015-12-10 Sanofi Sa Inhalable pharmaceutical compositions and the inhaler devices containing them
EP2923702A1 (en) * 2014-03-28 2015-09-30 Universite De Liege Composition of cyclodextrin with budesonide derivatives for treatment and prevention of pulmonary inflammatory disease
US10864213B2 (en) 2014-05-12 2020-12-15 Verona Pharma Plc Treatment
CZ2015257A3 (cs) * 2015-04-16 2016-10-26 Zentiva, K.S. Způsob pro zmenšování velikosti částic bromidu [(3R)-1-(3-fenoxypropyl)chinuklidin-1-ium-3-yl] 2-hydroxy-2,2-bis(2-thienyl)acetátu
CN107823193B (zh) * 2017-11-16 2021-02-05 广州迈达康医药科技有限公司 一种阿地溴铵吸入型粉雾剂及其制备方法

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