RS53784B2 - Inhalacioni lek koji obuhvata amorfni tiotropijum bromid - Google Patents

Inhalacioni lek koji obuhvata amorfni tiotropijum bromid

Info

Publication number
RS53784B2
RS53784B2 RS20140699A RSP20140699A RS53784B2 RS 53784 B2 RS53784 B2 RS 53784B2 RS 20140699 A RS20140699 A RS 20140699A RS P20140699 A RSP20140699 A RS P20140699A RS 53784 B2 RS53784 B2 RS 53784B2
Authority
RS
Serbia
Prior art keywords
solid
tiotropium bromide
drug
inhalation
pharmaceutically acceptable
Prior art date
Application number
RS20140699A
Other languages
English (en)
Inventor
Xian-Ming Zeng
Original Assignee
Norton Healthcare Ltd
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=38566522&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RS53784(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Norton Healthcare Ltd filed Critical Norton Healthcare Ltd
Publication of RS53784B1 publication Critical patent/RS53784B1/sr
Publication of RS53784B2 publication Critical patent/RS53784B2/sr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/439—Heterocyclic 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Claims (15)

Patentni zahtevi
1. Inhalacioni lek u obliku suvog praha koji obuhvata čvrste amorfne čestice i jedan ili više farmaceutski prihvatljivih ekscipijenata, gde čvrste amorfne čestice obuhvataju homogenu smešu tiotropijum bromida zajedno sa farmaceutski prihvatljivom ko-čvrstom materijom odabranom iz grupe koja se sastoji od dekstroze, fruktoze, glukozamina, glukoze, laktoze, manitola, maltitola, manoze, sorbitola, saharoze, trehaloze, ksilitola i njihovih kombinacija.
2. Lek prema zahtevu 1, gde ko-čvrsta materija ima rastvorljivost u vodi od najmanje 20 mg na 100 ml na 20°C.
3. Lek prema bilo kom od prethodnih zahteva, gde je veličina čvrstih amorfnih čestica 1-10 mikrona.
4. Lek prema bilo kom od prethodnih zahteva, gde je maseni odnos tiotropijum bromida prema ko -čvrstoj materiji od 1:1 do 1:1000.
5. Lek prema zahtevu 4, gde je maseni odnos tiotropijum bromida prema ko-čvrstoj materiji od 1:10 do 1:500.
6. Postupak za pripremanje inhalacionog leka u obliku suvog praha koji obuhvata čvrste amorfne čestice tiotropijum bromida, koji obuhvata liofilizaciju vodenog rastvora tiotropijum bromida, zajedno sa farmaceutski prihvatljivom ko-čvrstom materijom odabranom iz grupe koja se sastoji od dekstroze, fruktoze, glukozamina, glukoze, laktoze, manitola, maltitola, manoze, sorbitola, saharoze, trehaloze, ksilitola i njihovih kombinacija.
7. Postupak prema zahtevu 6, gde ko-čvrsta materija ima rastvorljivost u vodi od najmanje 20 mg na 100 ml na 20°C.
8. Postupak prema bilo kom od zahteva 6 do 7, koji dalje obuhvata mikronizovanje čestica.
9. Postupak prema bilo kom od zahteva 6 do 8, gde nagrađene čestice imaju veličinu od 1-10 mikrona.
10. Inhalacioni lek u obliku suvog praha koji se može dobiti postupkom prema bilo kom od zahteva 6 do 9.
11. Inhalacioni lek prema zahtevu 10, koji dalje obuhvata jedan ili više farmaceutski prihvatljivih ekscipijenata.
12. Inhalacioni lek prema zahtevu 11, gde jedan ili više farmaceutski prihvatljivih ekscipijenata uključuje inertni nosač.
13. Inhalacioni lek prema zahtevu 12, gde je inertni nosač odabran između laktoze, glukoze, natrijum skrob glikolata ili njihovih mešavina.
14. Kapsula koja se sastoji od inhalacionog leka prema bilo kom od zahteva 11 do 13.
15. Inhalator u obliku suvog praha koji obuhvata noseću konstrukciju, komoru za doziranje, usnik i lek prema bilo kom od zahteva 11 do 13 ili kapsulu prema zahtevu 14.
RS20140699A 2007-07-09 2008-07-03 Inhalacioni lek koji obuhvata amorfni tiotropijum bromid RS53784B2 (sr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US95882307P 2007-07-09 2007-07-09
GBGB0716026.0A GB0716026D0 (en) 2007-08-16 2007-08-16 An inhalable medicament
EP08775842.1A EP2175838B2 (en) 2007-07-09 2008-07-03 An inhalable medicament containinig amorphous tiotropium bromide
PCT/GB2008/002294 WO2009007687A2 (en) 2007-07-09 2008-07-03 An inhalable medicament

Publications (2)

Publication Number Publication Date
RS53784B1 RS53784B1 (sr) 2015-06-30
RS53784B2 true RS53784B2 (sr) 2018-07-31

Family

ID=38566522

Family Applications (1)

Application Number Title Priority Date Filing Date
RS20140699A RS53784B2 (sr) 2007-07-09 2008-07-03 Inhalacioni lek koji obuhvata amorfni tiotropijum bromid

Country Status (20)

Country Link
US (3) US8759369B2 (sr)
EP (1) EP2175838B2 (sr)
JP (1) JP5552049B2 (sr)
KR (1) KR101542632B1 (sr)
CN (1) CN101754749B (sr)
BR (1) BRPI0813564A2 (sr)
CA (1) CA2692606C (sr)
CY (1) CY1115937T1 (sr)
DK (1) DK2175838T4 (sr)
EA (2) EA030829B1 (sr)
ES (1) ES2526647T5 (sr)
GB (1) GB0716026D0 (sr)
HR (1) HRP20141175T4 (sr)
IL (2) IL203180A (sr)
MX (1) MX2010000315A (sr)
PL (1) PL2175838T5 (sr)
PT (1) PT2175838E (sr)
RS (1) RS53784B2 (sr)
SI (1) SI2175838T2 (sr)
WO (1) WO2009007687A2 (sr)

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KR101728116B1 (ko) * 2015-11-03 2017-04-18 한미약품 주식회사 티오트로피움 또는 이의 약학적으로 허용가능한 염을 함유하는 흡입용 건조분말 조성물
US20240058538A1 (en) * 2022-08-16 2024-02-22 Kaleo, Inc. Devices and methods for delivering reconstituted medicaments

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Also Published As

Publication number Publication date
EA030829B1 (ru) 2018-10-31
ES2526647T5 (es) 2017-10-10
IL203180A (en) 2015-01-29
EA201500111A1 (ru) 2015-10-30
JP2010533156A (ja) 2010-10-21
US20150150808A1 (en) 2015-06-04
EP2175838B1 (en) 2014-10-08
GB0716026D0 (en) 2007-09-26
US20140127304A1 (en) 2014-05-08
EA020968B1 (ru) 2015-03-31
CA2692606A1 (en) 2009-01-15
ES2526647T3 (es) 2015-01-14
CN101754749A (zh) 2010-06-23
EP2175838A2 (en) 2010-04-21
SI2175838T2 (sl) 2017-09-29
KR20100045999A (ko) 2010-05-04
WO2009007687A3 (en) 2009-06-04
KR101542632B1 (ko) 2015-08-06
IL236360A0 (en) 2015-09-24
DK2175838T4 (en) 2017-08-28
CA2692606C (en) 2014-04-01
CN101754749B (zh) 2016-04-13
JP5552049B2 (ja) 2014-07-16
WO2009007687A2 (en) 2009-01-15
HRP20141175T1 (hr) 2015-03-13
RS53784B1 (sr) 2015-06-30
BRPI0813564A2 (pt) 2015-08-25
PL2175838T5 (pl) 2018-03-30
DK2175838T3 (en) 2015-01-05
MX2010000315A (es) 2010-03-17
SI2175838T1 (sl) 2015-03-31
US20100326437A1 (en) 2010-12-30
US8759369B2 (en) 2014-06-24
PT2175838E (pt) 2015-01-14
EA201070115A1 (ru) 2010-06-30
HRP20141175T4 (hr) 2017-09-22
EP2175838B2 (en) 2017-06-07
PL2175838T3 (pl) 2015-05-29
CY1115937T1 (el) 2017-01-25

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