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HRP20210704T1 - Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom - Google Patents

Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom Download PDF

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Publication number
HRP20210704T1
HRP20210704T1 HRP20210704TT HRP20210704T HRP20210704T1 HR P20210704 T1 HRP20210704 T1 HR P20210704T1 HR P20210704T T HRP20210704T T HR P20210704TT HR P20210704 T HRP20210704 T HR P20210704T HR P20210704 T1 HRP20210704 T1 HR P20210704T1
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HR
Croatia
Prior art keywords
particles
powder formulation
microns
formulation according
fraction
Prior art date
Application number
HRP20210704TT
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English (en)
Inventor
Rossella Musa
Irene PASQUALI
Azita ASKEY-SARVAR
Francesca Schiaretti
Original Assignee
Chiesi Farmaceutici S.P.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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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51292914&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20210704(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chiesi Farmaceutici S.P.A. filed Critical Chiesi Farmaceutici S.P.A.
Publication of HRP20210704T1 publication Critical patent/HRP20210704T1/hr

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Classifications

    • 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
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • 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
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • 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
    • 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (12)

1. Formulacija suhog praška za upotrebu u inhalatoru za suhi prašak (DPI) za davanje inhalacijom, rečena formulacija sadrži: a) frakciju finih čestica koje sadrže smjesu od 90 do 99.5 posto po masi mikroniziranih čestica fiziološki prihvatljivog ekscipijensa i 0.5 do 10 posto po masi magnezijeva stearata, gdje najmanje 90% svih rečenih čestica ima volumni promjer manji od 15 mikrona, i volumni medijalni promjer rečenih čestica je između 3 i 7 mikrona, te ne više od 10% rečenih čestica ima promjer manji od 1.8 mikrona; b) frakciju grubih čestica koje sadrže fiziološki prihvatljiv ekscipijens koji ima promjer medijalne mase jednak ili veći od 100 mikrona, pri čemu je omjer između finih čestica a) i grubih čestica b) između 1:99 i 30:70 posto po masi; c) mikronizirane čestice glikopironijeva bromida, beklometazon-dipropionata, te formoterol-fumarat dihidrata kao aktivnih tvari; pri čemu najmanje 90% mikroniziranih čestica svake aktivne tvari ima volumni promjer jednak ili manji od 6 mikrona, i formulacija isporučuje terapijski učinkovitu dozu svih triju aktivnih tvari između 100 i 500 mikrograma; gdje se rečena formulacija može dobiti postupkom koji obuhvaća korake i) miješanje čestica ekscipijensa i magnezijeva stearata u visokoenergijskoj aparaturi u periodu manjem od 30 minuta; te ii) miješanje frakcije finih čestica a), frakcije grubih laktoza čestica b) i svih mikroniziranih aktivnih tvari; te pri čemu, nakon isporuke iz inhalatora, formulacija isporučuje frakciju aktivnih čestica u kojima 30% ili više čestica ima veličinu čestice jednaku ili manju od 2.0 mikrona.
2. Formulacija praška prema patentnom zahtjevu 1, naznačeno time da ne više od 10% finih čestica a) ima promjer manji od 1.5 mikrona.
3. Formulacija praška prema patentnom zahtjevu 1 ili 2, naznačeno time da visokoenergijska aparatura jest mehano-fuzijska aparatura.
4. Formulacija praška prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeno time da fiziološki prihvatljiv ekscipijens jest kristalinični šećer.
5. Formulacija praška prema patentnom zahtjevu 4, naznačeno time da se ekscipijens sastoji od alfa-laktoze monohidrata.
6. Formulacija praška prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da magnezijev stearat oblaže površinu čestica ekscipijensa fine frakcije a) na takav način da je stupanj obloženosti površine najmanje 50%.
7. Formulacija praška prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da najmanje 90% svih rečenih mikroniziranih čestica aktivnih tvari ima volumni promjer manji od 6.0 mikrona, a volumni medijalni promjer rečenih čestica jest između 1.2 i 2.5 mikrona.
8. Formulacija praška prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da grube čestice frakcije b) imaju promjer medijalne mase jednak ili veći od 175 mikrona.
9. Formulacija praška prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da omjer između finih čestica a) i grubih čestica b) jest 10:90 posto po masi.
10. Inhalator za suhi prašak punjen formulacijom suhog praška iz bilo kojeg od patentnih zahtjeva 1 do 10.
11. Formulacija suhog praška prema bilo kojem od patentnih zahtjeva 1 do 10 za upotrebu u sprječavanju i/ili liječenju upalne i/ili opstruktivne bolesti dišnih puteva.
12. Formulacija suhog praška prema patentnom zahtjevu 11, naznačeno time da upalna i/ili opstruktivna bolest dišnih puteva jest kronična opstruktivna plućna bolest (COPD).
HRP20210704TT 2013-07-11 2021-05-06 Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom HRP20210704T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13176114 2013-07-11
EP13194763 2013-11-28
EP18178893.6A EP3409270B1 (en) 2013-07-11 2014-07-10 Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation

Publications (1)

Publication Number Publication Date
HRP20210704T1 true HRP20210704T1 (hr) 2021-06-11

Family

ID=51292914

Family Applications (3)

Application Number Title Priority Date Filing Date
HRP20241300TT HRP20241300T1 (hr) 2013-07-11 2014-07-10 Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom
HRP20182008TT HRP20182008T1 (hr) 2013-07-11 2018-11-29 Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom
HRP20210704TT HRP20210704T1 (hr) 2013-07-11 2021-05-06 Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom

Family Applications Before (2)

Application Number Title Priority Date Filing Date
HRP20241300TT HRP20241300T1 (hr) 2013-07-11 2014-07-10 Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom
HRP20182008TT HRP20182008T1 (hr) 2013-07-11 2018-11-29 Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom

Country Status (36)

Country Link
US (2) US9402825B2 (hr)
EP (3) EP3019153B1 (hr)
JP (1) JP6426167B2 (hr)
KR (2) KR20160029797A (hr)
CN (1) CN105338960B (hr)
AR (1) AR129501A2 (hr)
AU (1) AU2014289185B2 (hr)
BR (1) BR112015030914B1 (hr)
CA (1) CA2917752C (hr)
CL (1) CL2016000028A1 (hr)
CY (2) CY1120806T1 (hr)
DK (3) DK3409270T3 (hr)
EA (1) EA029125B1 (hr)
ES (3) ES2867552T3 (hr)
FI (1) FI3569222T3 (hr)
GE (1) GEP20186853B (hr)
HK (1) HK1218712A1 (hr)
HR (3) HRP20241300T1 (hr)
HU (3) HUE053957T2 (hr)
IL (1) IL243507A0 (hr)
LT (3) LT3409270T (hr)
MX (1) MX2016000290A (hr)
MY (1) MY176176A (hr)
NZ (1) NZ715797A (hr)
PE (2) PE20160372A1 (hr)
PH (1) PH12016500043B1 (hr)
PL (3) PL3409270T3 (hr)
PT (1) PT3019153T (hr)
RS (3) RS65951B1 (hr)
SA (1) SA516370373B1 (hr)
SG (1) SG11201600110RA (hr)
SI (3) SI3409270T1 (hr)
TN (1) TN2016000007A1 (hr)
TW (1) TWI642450B (hr)
UA (1) UA116907C2 (hr)
WO (1) WO2015004243A1 (hr)

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Publication number Publication date
KR20210075217A (ko) 2021-06-22
EA029125B1 (ru) 2018-02-28
HK1218712A1 (zh) 2017-03-10
SI3409270T1 (sl) 2021-07-30
PH12016500043B1 (en) 2018-11-23
AU2014289185A1 (en) 2016-02-04
PL3019153T3 (pl) 2019-02-28
CN105338960B (zh) 2019-06-04
JP2016523950A (ja) 2016-08-12
LT3019153T (lt) 2018-11-26
HUE068270T2 (hu) 2024-12-28
CY1120806T1 (el) 2019-12-11
MY176176A (en) 2020-07-24
RS57799B1 (sr) 2018-12-31
UA116907C2 (uk) 2018-05-25
WO2015004243A1 (en) 2015-01-15
BR112015030914A2 (hr) 2017-07-25
MX2016000290A (es) 2016-04-13
DK3409270T3 (da) 2021-04-26
US9808422B2 (en) 2017-11-07
EP3569222A1 (en) 2019-11-20
CA2917752C (en) 2022-05-03
SI3019153T1 (sl) 2018-12-31
KR102275904B1 (ko) 2021-07-13
PL3409270T3 (pl) 2021-08-09
RS61652B1 (sr) 2021-04-29
HUE039827T2 (hu) 2019-02-28
EP3569222B1 (en) 2024-06-26
BR112015030914B1 (pt) 2023-04-04
IL243507A0 (en) 2016-02-29
PE20160372A1 (es) 2016-05-19
EP3019153A1 (en) 2016-05-18
CA2917752A1 (en) 2015-01-15
SA516370373B1 (ar) 2017-10-11
EA201690006A1 (ru) 2016-07-29
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