SI2349204T1 - Delci za vdihavanje, ki vsebujejo tiotropij - Google Patents

Delci za vdihavanje, ki vsebujejo tiotropij Download PDF

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Publication number
SI2349204T1
SI2349204T1 SI200931854T SI200931854T SI2349204T1 SI 2349204 T1 SI2349204 T1 SI 2349204T1 SI 200931854 T SI200931854 T SI 200931854T SI 200931854 T SI200931854 T SI 200931854T SI 2349204 T1 SI2349204 T1 SI 2349204T1
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SI
Slovenia
Prior art keywords
tiotropium
particles
stabilizing agent
pharmaceutical composition
particle size
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SI200931854T
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English (en)
Inventor
Karim Amighi
Guerra Antonio Sereno
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Laboratorios Liconsa, S.A.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40348057&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SI2349204(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Laboratorios Liconsa, S.A. filed Critical Laboratorios Liconsa, S.A.
Publication of SI2349204T1 publication Critical patent/SI2349204T1/sl

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    • 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
    • A61K9/0012Galenical 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
    • A61K31/33Heterocyclic 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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

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

Claims (11)

  1. DELCI ZA VDIHAVANJE, KI VSEBUJEJO TIOTROPIJ Patentni zahtevki
    1. Delci za vdihavanje, ki vsebujejo stabilno anhidridno amorfno obliko tiotropija s stabilizacijskim sredstvom, ki je laktoza, pri čemer stabilizirana amorfna oblika tiotropija skupaj s stabilizacijskim sredstvom vključuje matrico, v kateri je tiotropij razpršen v molekularnem stanju ali pri čemer stabilna amorfna oblika tiotropija s stabilizacijskim sredstvom vsebuje amorfen tiotropij razpršen na površino stabilizacijskega sredstva, in pri čemer so delci zmešani z eno ali več grobimi pomožnimi snovmi, ki imajo povprečno velikost delcev 15 do 250 mm.
  2. 2. Delci za vdihavanje po zahtevku 1, pri čemer tiotropij vsebuje tiotropijev bromid.
  3. 3. Delci za vdihavanje po kateremkoli izmed zahtevkov od 1 do 2, ki ima povprečno aerodinamično velikost delcev do 10 mm.
  4. 4. Delci za vdihavanje po zahtevku 1, pri čemer je groba pomožna snov laktoza.
  5. 5. Farmacevtska zmes, ki vsebuje delce za vdihavanje po zahtevku 1 ali zahtevku 4.
  6. 6. Farmacevtska zmes po zahtevku 5, pri čemer je vsebnost tiotropijeve baze med 0,02 do 0,8%.
  7. 7. Farmacevtska zmes po kateremkoli zahtevku od 5 do 6, v obliki kapsul za vdihavanje.
  8. 8. Farmacevtska zmes po zahtevku 7, pri čemer kapsule vsebujejo hidroksipropilmetilcelulozo.
  9. 9. Postopek za pripravo delcev za vdihavanje po kateremkoli izmed zahtevkov od 1 do 4, ki vključuje sledeče korake: a. raztapljanje ali razprševanje stabilizacijskega sredstva v hlapnem topilu, ki se dobro meša z vodo, ki po izbiri lahko vsebuje vodo, da nastane raztopina ali suspenzija; b. raztapljanje tiotropijeve soli ali njenega solvata, ali kateremkoli njene trdne oblike, v hlapnem topilu, ki se dobro meša z vodo, ki po izbiri lahko vsebuje vodo; c. mešanje raztopine iz koraka b) in raztopine ali suspenzije iz koraka a); d. sušenje z razprševanje raztopine/suspenzije iz koraka c) da se dobijo želeni delci; in e. mešanje delcev iz koraka d) z enim ali več grobih pomožnih snovi, ki imajo povprečno velikost delcev 15 do 250 mm.
  10. 10. Postopek po zahtevku 9, pri čemer ko se v koraku a) tvori suspenzija, uporabljeno topilo ne vsebuje vode in je stabilizacijsko sredstvo v obliki delcev, ki imajo povprečno velikost delcev 1 do 9 mm.
  11. 11. Delci za vdihavanje kot so definirani v kateremkoli izmed zahtevkov od 1 do 4 za uporabo pri zdravljenju astme ali kronične obstruktivne pljučne bolezni.
SI200931854T 2008-10-02 2009-10-02 Delci za vdihavanje, ki vsebujejo tiotropij SI2349204T1 (sl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP08382040A EP2172190A1 (en) 2008-10-02 2008-10-02 Inhalable particles comprising tiotropium
US10411308P 2008-10-09 2008-10-09
EP09783687.8A EP2349204B1 (en) 2008-10-02 2009-10-02 Inhalable particles comprising tiotropium
PCT/EP2009/062821 WO2010037845A1 (en) 2008-10-02 2009-10-02 Inhalable particles comprising tiotropium

Publications (1)

Publication Number Publication Date
SI2349204T1 true SI2349204T1 (sl) 2018-08-31

Family

ID=40348057

Family Applications (1)

Application Number Title Priority Date Filing Date
SI200931854T SI2349204T1 (sl) 2008-10-02 2009-10-02 Delci za vdihavanje, ki vsebujejo tiotropij

Country Status (38)

Country Link
US (1) US20110311618A1 (sl)
EP (2) EP2172190A1 (sl)
JP (1) JP5622730B2 (sl)
KR (1) KR101639089B1 (sl)
CN (1) CN102170861B (sl)
AR (1) AR073528A1 (sl)
AU (1) AU2009299801B2 (sl)
BR (1) BRPI0920706B8 (sl)
CA (1) CA2737399C (sl)
CL (1) CL2011000696A1 (sl)
CO (1) CO6361899A2 (sl)
CR (1) CR20110227A (sl)
CY (1) CY1121090T1 (sl)
DK (1) DK2349204T3 (sl)
DO (1) DOP2011000091A (sl)
EC (1) ECSP11010925A (sl)
ES (1) ES2675857T3 (sl)
HN (1) HN2011000864A (sl)
HR (1) HRP20181009T1 (sl)
HU (1) HUE038208T2 (sl)
LT (1) LT2349204T (sl)
MA (1) MA34560B1 (sl)
MX (1) MX2011003491A (sl)
MY (1) MY159172A (sl)
NI (1) NI201100066A (sl)
NZ (1) NZ591923A (sl)
PE (2) PE20142435A1 (sl)
PL (1) PL2349204T3 (sl)
PT (1) PT2349204T (sl)
RU (2) RU2011117256A (sl)
SI (1) SI2349204T1 (sl)
SV (1) SV2011003852A (sl)
TR (1) TR201808269T4 (sl)
TW (1) TWI433675B (sl)
UA (1) UA100777C2 (sl)
UY (1) UY32160A (sl)
WO (1) WO2010037845A1 (sl)
ZA (1) ZA201101735B (sl)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2012138909A (ru) * 2010-03-31 2014-05-10 Гленмарк Фармасьютикалс Лимитед Фармацевтическая порошковая композиция для ингаляций
WO2011152804A2 (en) * 2010-06-03 2011-12-08 Mahmut Bilgic Process for dry powder formulations
WO2011154014A1 (en) * 2010-06-11 2011-12-15 Gea Process Engineering A/S Controlled humidity drying
ES2769576T3 (es) 2010-08-23 2020-06-26 Fraunhofer Ges Forschung Partículas humidificadas que comprenden una sustancia terapéuticamente activa
WO2013109216A2 (en) * 2012-01-16 2013-07-25 Mahmut Bilgic Preparation of dry powder formulations comprising tiotropium
DE102013012914A1 (de) 2012-08-03 2014-02-20 Gheorghe George Olaru Hot runner injection molding apparatus with additional controller
EP2705838A1 (en) * 2012-09-06 2014-03-12 Xspray Microparticles Ab Tiotropium preparations
CN105324106A (zh) 2013-04-01 2016-02-10 普马特里克斯营业公司 噻托铵干粉
KR101748796B1 (ko) * 2015-09-30 2017-06-19 한미약품 주식회사 활성성분의 전달량이 향상된 흡입용 캡슐제
EP4108230A1 (en) * 2021-06-24 2022-12-28 Laboratoires SMB New dry powder composition of tiotropium for inhalation
GR1010358B (el) * 2021-09-14 2022-12-16 Elpen Ανωνυμος Εταιρεια Φαρμακευτικη Βιομηχανια, Σταθερο φαρμακευτικο σκευασμα που περιεχει βρωμιουχο τιοτροπιο, για χορηγηση απο το αναπνευστικο
CN114191418B (zh) * 2021-12-21 2023-06-09 丽珠医药集团股份有限公司 噻托溴铵双层微球及其制备方法和噻托溴铵缓释吸入剂

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Also Published As

Publication number Publication date
KR101639089B1 (ko) 2016-07-12
WO2010037845A1 (en) 2010-04-08
PT2349204T (pt) 2018-07-06
US20110311618A1 (en) 2011-12-22
TW201018468A (en) 2010-05-16
BRPI0920706A2 (pt) 2015-12-29
CN102170861A (zh) 2011-08-31
PE20110850A1 (es) 2011-11-25
PE20142435A1 (es) 2015-01-11
HN2011000864A (es) 2015-02-09
CY1121090T1 (el) 2019-12-11
SV2011003852A (es) 2011-04-12
EP2172190A1 (en) 2010-04-07
AR073528A1 (es) 2010-11-10
HRP20181009T1 (hr) 2018-08-24
BRPI0920706B1 (pt) 2021-02-02
CL2011000696A1 (es) 2011-07-29
CA2737399A1 (en) 2010-04-08
RU2014150986A3 (sl) 2018-07-02
MX2011003491A (es) 2011-06-16
EP2349204A1 (en) 2011-08-03
UA100777C2 (ru) 2013-01-25
CN102170861B (zh) 2014-05-14
CO6361899A2 (es) 2012-01-20
UY32160A (es) 2010-04-30
AU2009299801A1 (en) 2010-04-08
CA2737399C (en) 2017-02-21
LT2349204T (lt) 2018-10-10
TWI433675B (zh) 2014-04-11
BRPI0920706B8 (pt) 2021-05-25
HUE038208T2 (hu) 2018-10-29
KR20110081265A (ko) 2011-07-13
DOP2011000091A (es) 2011-04-30
RU2014150986A (ru) 2015-06-10
NZ591923A (en) 2012-02-24
EP2349204B1 (en) 2018-04-11
TR201808269T4 (tr) 2018-07-23
MY159172A (en) 2016-12-30
CR20110227A (es) 2011-06-24
ES2675857T3 (es) 2018-07-13
MA34560B1 (fr) 2013-10-02
ZA201101735B (en) 2012-05-30
NI201100066A (es) 2012-01-05
AU2009299801B2 (en) 2014-02-27
RU2685236C2 (ru) 2019-04-17
JP5622730B2 (ja) 2014-11-12
RU2011117256A (ru) 2012-11-10
DK2349204T3 (en) 2018-07-16
JP2012504580A (ja) 2012-02-23
PL2349204T3 (pl) 2018-09-28
ECSP11010925A (es) 2011-07-29

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