DK3019153T3 - Tørpulverformulering omfattende et antikolinergikum, et corticosteroid og et beta-adrenergikum til indgivelse ved inhalation - Google Patents
Tørpulverformulering omfattende et antikolinergikum, et corticosteroid og et beta-adrenergikum til indgivelse ved inhalation Download PDFInfo
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- DK3019153T3 DK3019153T3 DK14747855.6T DK14747855T DK3019153T3 DK 3019153 T3 DK3019153 T3 DK 3019153T3 DK 14747855 T DK14747855 T DK 14747855T DK 3019153 T3 DK3019153 T3 DK 3019153T3
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Classifications
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- A61K31/573—Compounds 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
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (11)
1. Tørpulverformulering til anvendelse i en tørpulverinhalator (DPI) til afgivelse ved inhalation af en kombination af mikroniserede partikler af glycopyrronium-bromid, beclometasondipropionat og formoterolfumaratdihydrat som aktive bestanddele i en kombineret terapeutisk virksom dosis på 100 til 500 pg, hvor formuleringen omfatter: a) en fraktion af fine partikler bestående af en blanding på 90 til 99,5 vægtprocent af mikroniserede partikler af et fysiologisk acceptabelt hjælpestof og 0,5 til 10 vægtprocent magnesiumstearat, hvor mindst 90 % af alle partiklerne har en volumendiameter på mindre end 12 mikron, den gennemsnitlige volumendiameter af partiklerne er på 3 til 7 mikron, og ikke mere end 10 % af partiklerne har en diameter, der er lavere end 1,5 mikron; b) en fraktion af grove partikler bestående af et fysiologisk acceptabelt hjælpestof, der har en gennemsnitlig massediameter, der er lig med eller højere end 175 mikron, hvor forholdet mellem de fine partikler a) og de grove partikler b) er mellem 1:99 og 30:70 vægtprocent; hvor mindst 90 % af alle mikroniserede partikler af de aktive bestanddele har en volumendiameter, der er lavere end 6,0 mikron, deres gennemsnitlige volumendiameter er mellem 1,2 og 2,5 mikron og bredden af deres partikelstørrelsesfordeling, udtrykt som et spænd, ligger mellem 1,2 og 3,0; hvor formuleringen opnås ved en fremgangsmåde omfattende de følgende trin: i) at fremstille fraktionen af fine partikler a) ved co-blanding i en højenergiindretning i en periode på mindre end 20 minutter, ii) at blande fraktionen af fine partikler a), fraktionen af grove partikler b) og alle de mikroniserede aktive bestanddele.
2. Tørpulverformulering ifølge krav 1, hvor de fine partikler a) co-blandes i et tidsrum på mellem 2 og 15 minutter.
3. Tørpulverformulering ifølge krav 1 eller 2, hvor mindst 90 % af de mikroniserede partikler af de aktive bestanddele har en volumendiameter, der er lig med eller lavere end 5,0 mikron.
4. Tørpulverformulering ifølge krav 3, hvor den gennemsnitlige volumendiameter af partiklerne ligger mellem 1,3 og 2,2 mikron.
5. Tørpulverformulering ifølge et af kravene 1 til 4, hvor magnesiumstearat dækker overfladen af de overskydende partikler a) på en sådan måde, at overfladebelægningens omfang er mindst 50%.
6. Tørpulverformulering ifølge krav 5, hvor højenergi-indretningen er en me-chano-fusionsindretning.
7. Tørpulverformulering ifølge et af de foregående krav, hvor forholdet mellem de fine partikler a) og de grove partikler b) ligger mellem 5:95 og 15:85 vægtprocent.
8. Tørpulverformulering ifølge et af de foregående krav, hvor diameteren af de grove partikler b) ligger mellem 210 og 355 mikron.
9. Tørpulverinhalatorindretning omfattende en tørpulverformulering ifølge et af kravene 1 til 8.
10. Tørpulverformulering ifølge et af kravene 1 til 8 til anvendelse ved forebyggelse og/eller behandling af en inflammatorisk eller obstruktiv luftvejssygdom.
11. Tørpulverformulering ifølge krav 10, hvor den inflammatoriske og/eller ob-struktive luftvejssygdom er kronisk obstruktiv lungesygdom (COPD).
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
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| EP13176114 | 2013-07-11 | ||
| EP13194763 | 2013-11-28 | ||
| PCT/EP2014/064824 WO2015004243A1 (en) | 2013-07-11 | 2014-07-10 | Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation |
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| DK3019153T3 true DK3019153T3 (da) | 2018-11-19 |
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| DK19182016.6T DK3569222T3 (da) | 2013-07-11 | 2014-07-10 | Tørpulverformulering omfattende en anticholinergikum, en corticosteroid og en beta-andrenergikum til indgivelse ved inhalering |
| DK18178893.6T DK3409270T3 (da) | 2013-07-11 | 2014-07-10 | Tørpulverformulering omfattende et antikolinergikum, et corticosteroid og et beta-adrenergikum til indgivelse ved inhalation |
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| DK18178893.6T DK3409270T3 (da) | 2013-07-11 | 2014-07-10 | Tørpulverformulering omfattende et antikolinergikum, et corticosteroid og et beta-adrenergikum til indgivelse ved inhalation |
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| PH12012501066A1 (en) * | 2009-12-23 | 2016-03-02 | Chiesi Farm Spa | Combination therapy for copd |
| EP3527197B1 (en) * | 2012-01-25 | 2022-09-07 | Chiesi Farmaceutici S.p.A. | Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation |
| EP3019153B1 (en) * | 2013-07-11 | 2018-09-05 | Chiesi Farmaceutici S.p.A. | Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation |
| GB201321717D0 (en) * | 2013-12-09 | 2014-01-22 | Pharmachemie Bv | Inhalable Medicaments |
| US9554992B2 (en) | 2014-06-09 | 2017-01-31 | Chiesi Farmaceutici S.P.A. | Inhalation particles comprising a combination of an anticholinergic, a corticosteroid and a beta-adrenergic |
| TR201407010A2 (tr) | 2014-06-16 | 2015-12-21 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Vilanterol formülasyonları. |
| JP6600961B2 (ja) * | 2015-03-30 | 2019-11-06 | ブラザー工業株式会社 | 表示制御装置、表示制御方法及び記憶媒体 |
| AU2015393953B2 (en) * | 2015-05-01 | 2021-09-02 | Board Of Regents, The University Of Texas System | Multidrug brittle matrix compositions |
| DK3689379T3 (da) * | 2015-11-16 | 2021-09-06 | Chiesi Farm Spa | Fremgangsmåde til fremstilling af en tørpulverformulering omfattende et anticholinergikum, et corticosteroid og et beta-adrenergikum |
| PT3628331T (pt) * | 2015-11-16 | 2021-10-20 | Chiesi Farm Spa | Processo para preparar uma formulação de pó seco que compreende um anticolinérgico, um corticosteroide e um beta-adrenérgico |
| DE202017007678U1 (de) | 2016-11-10 | 2024-02-27 | Medisca Pharmaceutique Inc. | System zur pharmazeutischen Zubereitung |
| CA3060020A1 (en) * | 2017-05-11 | 2018-11-15 | Chiesi Farmaceutici S.P.A. | A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic |
| CA3059824A1 (en) | 2017-05-11 | 2018-11-15 | Chiesi Farmaceutici S.P.A. | A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic |
| CN109200034A (zh) * | 2017-06-30 | 2019-01-15 | 正大天晴药业集团股份有限公司 | 一种可吸入干粉形式的组合物及其制备方法 |
| WO2019060595A1 (en) | 2017-09-20 | 2019-03-28 | Teva Branded Pharmaceutical Products R&D, Inc. | INHALABLE DRY POWDER MEDICINAL PRODUCT COMPRISING GLYCOPYRRONIUM |
| AU2020356243A1 (en) * | 2019-09-24 | 2022-03-24 | Chiesi Farmaceutici S.P.A. | Novel carrier particles for dry powder formulations for inhalation |
| US12029709B2 (en) * | 2022-08-11 | 2024-07-09 | De Motu Cordis Pty Ltd | Inhalable epinephrine formulation |
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| US20070212422A1 (en) * | 1999-11-10 | 2007-09-13 | Manfred Keller | Dry powder for inhalation |
| CA2347856C (en) * | 1998-11-13 | 2009-02-17 | Jago Research Ag | Dry powder for inhalation |
| PE20011227A1 (es) | 2000-04-17 | 2002-01-07 | Chiesi Farma Spa | Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros |
| GB0015043D0 (en) | 2000-06-21 | 2000-08-09 | Glaxo Group Ltd | Medicament dispenser |
| JP5698423B2 (ja) * | 2000-06-27 | 2015-04-08 | ベクトゥラ・リミテッド | 医薬組成物で使用するための粒子の製造法 |
| PT1920763E (pt) * | 2000-11-30 | 2014-06-25 | Vectura Ltd | Composições farmacêuticas para inalação |
| PT1386630E (pt) | 2002-07-31 | 2006-09-29 | Chiesi Farma Spa | Inalador em po |
| JO3102B1 (ar) * | 2004-03-17 | 2017-09-20 | Chiesi Framaceutici S P A | صيغ صيدلانية لوسائل استنشاق بها مسحوق جاف تشتمل على مكون فعال بقوة منخفضة الجرعة |
| GB0425758D0 (en) * | 2004-11-23 | 2004-12-22 | Vectura Ltd | Preparation of pharmaceutical compositions |
| GB0613161D0 (en) | 2006-06-30 | 2006-08-09 | Novartis Ag | Organic Compounds |
| EP1944018A1 (en) * | 2007-01-10 | 2008-07-16 | CHIESI FARMACEUTICI S.p.A. | Micronised particles of low-dosage strength active agents for powder formulations for inhalation |
| PH12012501066A1 (en) * | 2009-12-23 | 2016-03-02 | Chiesi Farm Spa | Combination therapy for copd |
| KR101738712B1 (ko) | 2009-12-23 | 2017-05-22 | 키에시 파르마슈티시 엣스. 피. 에이. | Copd용 조합요법 |
| TR201000681A2 (tr) | 2010-01-29 | 2011-08-22 | B�Lg�� Mahmut | İnhalasyon yoluyla alınan kuru toz formülasyonları. |
| AU2011234751B2 (en) * | 2010-04-01 | 2016-03-17 | Chiesi Farmaceutici S.P.A. | Process for preparing carrier particles for dry powders for inhalation |
| RU2580312C2 (ru) * | 2010-04-21 | 2016-04-10 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Способ получения частиц с пониженным электростатическим зарядом |
| EP2585047A1 (en) * | 2010-06-22 | 2013-05-01 | Chiesi Farmaceutici S.p.A. | Dry powder formulation comprising an antimuscarinic drug |
| EP3527197B1 (en) | 2012-01-25 | 2022-09-07 | Chiesi Farmaceutici S.p.A. | Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation |
| US9393202B2 (en) | 2013-04-26 | 2016-07-19 | Chiesi Farmaceutici S.P.A | Particle size reduction of an antimuscarinic compound |
| EP3019153B1 (en) * | 2013-07-11 | 2018-09-05 | Chiesi Farmaceutici S.p.A. | Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation |
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