HRP20160630T1 - Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata - Google Patents

Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata Download PDF

Info

Publication number
HRP20160630T1
HRP20160630T1 HRP20160630TT HRP20160630T HRP20160630T1 HR P20160630 T1 HRP20160630 T1 HR P20160630T1 HR P20160630T T HRP20160630T T HR P20160630TT HR P20160630 T HRP20160630 T HR P20160630T HR P20160630 T1 HRP20160630 T1 HR P20160630T1
Authority
HR
Croatia
Prior art keywords
formulation according
formoterol
fumarate dihydrate
formulation
inhaler
Prior art date
Application number
HRP20160630TT
Other languages
English (en)
Inventor
Gaetano Brambilla
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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42035850&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20160630(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 HRP20160630T1 publication Critical patent/HRP20160630T1/hr

Links

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
    • A61K9/008Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61K31/535Heterocyclic 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
    • A61K31/537Heterocyclic 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 spiro-condensed or forming part of bridged ring systems
    • 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
    • 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
    • A61K9/12Aerosols; Foams
    • 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
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (20)

1. Farmaceutska aerosolna formulacija za upotrebu u inhalatorima sa stlačenim inhalatom koja sadrži sljedeće: (a) od 0.001 do 0.05% w/w formoterol-fumarat dihidrata; (b) od 0.05 do 0.16% w/w beklometazon-dipropionata; (c) od 2.0 do 4.8% w/w etanola; (d) 1,1,1,2-tetrafluoretan (HFA 134a); te (e) od 0.002 do 0.05% w/w lecitina ili oleinske kiseline kao surfaktanta; naznačena time da je HFA 134a jedini propelant te da je formoterol-fumarat dihidrat suspendiran u formulaciji u usitnjenom obliku dok je beklometazon-dipropionat potpuno otopljen.
2. Formulacija prema patentnom zahtjevu 1, koja sadrži kao aktivne sastojke samo kombinaciju formoterol-fumarat dihidrata i beklometazon-dipropionata.
3. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 2, naznačena time da koncentracija formoterol-fumarat dihidrata jest između 0.002 i 0.03% w/w.
4. Formulacija prema patentnom zahtjevu 3, naznačena time da koncentracija formoterol-fumarat dihidrata jest između 0.0025 do 0.01% w/w.
5. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time da koncentracija beklometazon-dipropionata jest između 0.06 i 0.12% w/w.
6. Formulacija prema patentnom zahtjevu 5, naznačena time da koncentracija beklometazon-dipropionata jest između 0.07 i 0.1% w/w.
7. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time da sadržaj etanola jest između 2.2 i 4.5% w/w.
8. Formulacija prema patentnom zahtjevu 7, naznačena time da rečeni sadržaj jest između 2.5 i 4.0% w/w.
9. Formulacija prema patentnom zahtjevu 8, naznačena time da rečeni sadržaj jest između 2.6 i 3.5% w/w.
10. Formulacija prema patentnom zahtjevu 9, naznačena time da rečeni sadržaj jest između 3.0 i 3.5% w/w.
11. Formulacija prema patentnom zahtjevu 1, naznačena time da sadržaj oleinske kiseline jest između 0.002 i 0.05% w/w.
12. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva koja je sposobna isporučiti 6 ili 12 µg formoterol-fumarat dihidrata i 50 ili 100 µg beklometazon-dipropionata po pokretanju.
13. Formulacija prema patentnom zahtjevu 12 koja je sposobna isporučiti 6 µg formoterol-fumarat dihidrata i 100 µg beklometazon-dipropionata po pokretanju.
14. Farmaceutska aerosolna formulacija prema patentnom zahtjevu 1 za upotrebu u inhalatorima sa stlačenim inhalatom koji je sposoban isporučiti 6 µg formoterol-fumarat dihidrata i 100 µg beklometazon-dipropionata po pokretanju, a rečena formulacija sadrži: (a) od 0.001 do 0.05 % w/w formoterol-fumarat dihidrata; (b) od 0.05 do 0.16 % w/w beklometazon-dipropionata; (c) od 2.0 do 4.8% w/w etanola; (d) 1,1,1,2-tetrafluoretan (HFA 134a); te (e) od 0.002 te 0.05% w/w oleinske kiseline; naznačena time da je HFA 134a jedini propelant te da je formoterol-fumarat dihidrat suspendiran u formulaciji u usitnjenom obliku dok je beklometazon-dipropionat potpuno otopljen.
15. Inhalator sa stlačenim inhalatom koji sadrži spremnik napunjen farmaceutskom aerosolnom formulacijom iz bilo kojeg od patentnih zahtjeva 1 do 14, te odmjerni ventil za isporuku terapijski učinkovitih doza aktivnih sastojaka.
16. Inhalator sa stlačenim inhalatom prema patentnom zahtjevu 15, naznačen time da je spremnik napravljen od aluminija.
17. Inhalator sa stlačenim inhalatom prema patentnom zahtjevu 15 ili 16, naznačen time da je odmjerni ventil sposoban isporučiti volumen između 50 i 100 µl.
18. Inhalator sa stlačenim inhalatom prema patentnom zahtjevu 17, naznačen time da je odmjerni ventil sposoban isporučiti volumen od 50 ili 63 µl.
19. Farmaceutska aerosolna formulacija iz bilo kojeg od patentnih zahtjeva 1 do 14 za upotrebu za prevenciju i/ili liječenje blagih, umjerenih ili ozbiljnih, akutnih ili kroničnih simptoma ili za profilaktičko liječenje respiratornih bolesti.
20. Formulacija prema patentnom zahtjevu 19, naznačena time da bolest jest astma ili kronična opstruktivna bolest pluća.
HRP20160630TT 2009-10-02 2016-06-08 Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata HRP20160630T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09172083 2009-10-02
EP14153337.2A EP2727582B1 (en) 2009-10-02 2010-09-27 Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate

Publications (1)

Publication Number Publication Date
HRP20160630T1 true HRP20160630T1 (hr) 2016-07-01

Family

ID=42035850

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20140818AT HRP20140818T1 (hr) 2009-10-02 2014-09-01 Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata
HRP20160630TT HRP20160630T1 (hr) 2009-10-02 2016-06-08 Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HRP20140818AT HRP20140818T1 (hr) 2009-10-02 2014-09-01 Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata

Country Status (22)

Country Link
US (1) US8420060B2 (hr)
EP (2) EP2482799B1 (hr)
KR (1) KR101778814B1 (hr)
CN (2) CN102548537B (hr)
AR (2) AR078494A1 (hr)
BR (1) BR112012007484A2 (hr)
CA (1) CA2776266C (hr)
CY (2) CY1115266T1 (hr)
DK (2) DK2727582T3 (hr)
ES (2) ES2487626T3 (hr)
HK (2) HK1167817A1 (hr)
HR (2) HRP20140818T1 (hr)
HU (1) HUE029159T2 (hr)
JO (1) JO3024B1 (hr)
ME (1) ME02398B (hr)
PL (2) PL2482799T3 (hr)
PT (1) PT2482799E (hr)
RS (2) RS53514B1 (hr)
RU (1) RU2650175C2 (hr)
SI (2) SI2482799T1 (hr)
TW (1) TWI449523B (hr)
WO (1) WO2011038872A1 (hr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9119777B2 (en) * 2008-05-30 2015-09-01 Microdose Therapeutx, Inc. Methods and compositions for administration of oxybutynin
NZ627837A (en) * 2012-01-25 2016-04-29 Chiesi Farma Spa Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation
US11052202B2 (en) * 2012-11-07 2021-07-06 Chiesi Farmaceutici S.P.A. Drug delivery device for the treatment of patients with respiratory diseases
EP3383366B2 (en) * 2015-12-04 2024-06-05 Mexichem Fluor S.A. de C.V. Pharmaceutical composition
CN112438966B (zh) * 2019-08-30 2022-08-26 四川普锐特药业有限公司 一种医用定量吸入气雾剂

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5290539A (en) 1990-12-21 1994-03-01 Minnesota Mining And Manufacturing Company Device for delivering an aerosol
JP3172190B2 (ja) 1993-07-15 2001-06-04 ミネソタ マイニング アンド マニュファクチャリング カンパニー 医薬エアロゾルを配給するための器具
GB9612297D0 (en) * 1996-06-11 1996-08-14 Minnesota Mining & Mfg Medicinal aerosol formulations
US6423298B2 (en) * 1998-06-18 2002-07-23 Boehringer Ingelheim Pharmaceuticals, Inc. Pharmaceutical formulations for aerosols with two or more active substances
SE9900833D0 (sv) * 1999-03-09 1999-03-09 Astra Ab Novel combination
IT1317720B1 (it) 2000-01-07 2003-07-15 Chiesi Farma Spa Dispositivo per la somministrazione di aerosol dosati pressurizzati inpropellenti idrofluoroalcani.
ME00220B (me) 2000-05-22 2010-10-10 Chiesi Farm Spa Stabilne farmaceutske formulacije rastvora za inhalatore odmjerene doze pod pritiskom
US6472563B1 (en) * 2001-11-09 2002-10-29 Sepracor Inc. Formoterol tartrate process and polymorph
GB0205327D0 (en) * 2002-03-06 2002-04-17 Glaxo Group Ltd compounds
GB0323685D0 (en) * 2003-10-09 2003-11-12 Jagotec Ag Improvements in or relating to organic compounds
EP1982709A1 (en) * 2007-04-19 2008-10-22 CHIESI FARMACEUTICI S.p.A. Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma
RU2356537C2 (ru) * 2007-07-25 2009-05-27 Закрытое Акционерное Общество (ЗАО) "Пульмомед" Фармацевтический состав дозированных аэрозолей, содержащий противоастматические лекарственные средства в виде суспензий, растворов, эмульсий, растворов и эмульсий

Also Published As

Publication number Publication date
RS54721B1 (en) 2016-08-31
EP2482799B1 (en) 2014-06-18
TW201119644A (en) 2011-06-16
AR078494A1 (es) 2011-11-09
CN103919785A (zh) 2014-07-16
RU2012112454A (ru) 2013-11-10
HRP20140818T1 (hr) 2014-10-10
CN102548537A (zh) 2012-07-04
KR20120100901A (ko) 2012-09-12
US8420060B2 (en) 2013-04-16
HK1199214A1 (en) 2015-06-26
RS53514B1 (en) 2015-02-27
KR101778814B1 (ko) 2017-09-15
ME02398B (me) 2016-09-20
US20110081301A1 (en) 2011-04-07
CN102548537B (zh) 2014-06-25
AR123674A2 (es) 2023-01-04
WO2011038872A1 (en) 2011-04-07
JO3024B1 (ar) 2016-09-05
ES2487626T3 (es) 2014-08-22
HK1167817A1 (en) 2012-12-14
EP2482799A1 (en) 2012-08-08
SI2482799T1 (sl) 2014-10-30
CA2776266A1 (en) 2011-04-07
EP2727582B1 (en) 2016-03-16
CA2776266C (en) 2017-11-28
CN103919785B (zh) 2016-08-24
CY1115266T1 (el) 2017-01-04
CY1117596T1 (el) 2017-04-26
PT2482799E (pt) 2014-08-06
RU2650175C2 (ru) 2018-04-10
HUE029159T2 (hu) 2017-02-28
TWI449523B (zh) 2014-08-21
DK2482799T3 (da) 2014-09-01
SI2727582T1 (sl) 2016-05-31
BR112012007484A2 (pt) 2020-06-09
PL2727582T3 (pl) 2016-06-30
PL2482799T3 (pl) 2014-11-28
ES2568913T3 (es) 2016-05-05
DK2727582T3 (en) 2016-05-17
EP2727582A1 (en) 2014-05-07

Similar Documents

Publication Publication Date Title
HRP20130835T1 (hr) Farmaceutske formulacije otopine za davanje kao stlaäśeni inhalat u inhalatoru
HRP20160630T1 (hr) Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata
HRP20210704T1 (hr) Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom
PE20160853A1 (es) Terapia combinada para enfermedad pulmonar obstructiva cronica (epoc)
MY143517A (en) Formoterol superfine formulation
HRP20140550T1 (hr) Aerosolna formulacija za copd
NZ585856A (en) Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease
RU2013142268A (ru) Фармацевтическая композиция
HRP20151214T4 (hr) Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti
HRP20221431T1 (hr) Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom
JP2013507429A5 (hr)
PH12014502662A1 (en) Novel dosage form and formulation of abediterol
NZ599900A (en) Pharmaceutical suspension aerosol formulations for use in metered dose inhalers
NZ591174A (en) Metered dose inhaler
JP2004529108A5 (hr)
GB201118188D0 (en) Manufacture of medicinal aerosol canisters
MY187442A (en) A pharmaceutical composition containing budesonide and formoterol
MX2022008440A (es) Inhaladores de dosis medida presurizada que comprenden una formulacion farmaceutica amortiguada.
WO2007046113A3 (en) Novel pharmaceutical composition comprising alkaloid and process thereof
MX2017004583A (es) Composicion farmaceutica que contiene budesonida y formoterol.
Boukhettala et al. Study of the performances of a new spacer in mechanical ventilation
von Hollen et al. In Vitro Comparison Of Aerosol Characteristics Of HFA Albuterol Pressurized Metered Dose Inhaler Formulation From Anti-Static Valved Holding Chambers
AR085443A1 (es) Formulaciones medicinales en aerosol que no dañan la capa de ozono y con bajo efecto invernadero
TH66681A (th) สูตรผสมที่ละเอียดเป็นพิเศษของฟอร์มอเทอรอล