HUE025463T2 - Glikopirrolát és magnézium-sztearát száraz por kompozíciói - Google Patents
Glikopirrolát és magnézium-sztearát száraz por kompozíciói Download PDFInfo
- Publication number
- HUE025463T2 HUE025463T2 HUE11190637A HUE11190637A HUE025463T2 HU E025463 T2 HUE025463 T2 HU E025463T2 HU E11190637 A HUE11190637 A HU E11190637A HU E11190637 A HUE11190637 A HU E11190637A HU E025463 T2 HUE025463 T2 HU E025463T2
- Authority
- HU
- Hungary
- Prior art keywords
- formulation
- glycopyrrolate
- dry powder
- magnesium stearate
- moisture
- Prior art date
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
-
- 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
- A61K9/141—Intimate 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
- A61K9/145—Intimate 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
-
- 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
- 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
- A61K31/40—Heterocyclic 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
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
-
- 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)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (8)
- Szabadalmi igénypontok 1< inhalálásra alkalmas,: giiköpWöiiiÄ és magnézinm-szteafâtoi tartalmazó száraz por kiszerelés, amelyben a giikopirrolát rníkronizált és azután átment egy kondicionáló lépésen:, amely lépés magában foglalja a termék kihelyezését 50-90% relatív nadvességtartalmu ptí) nedves körülmények közé 10 --- 50°C közötti hőmérsékleten legalább 48 órán át.
- 2. Az 1. igénypont szerinti kiszerelés, ahoi a kiszerelés magnézíum-sztearát tartalma >0,05% és <5%.
- 3. Az 1. vagy 2. igénypont szerinti kiszerelés, ahol a kiszerelés továbbá tartalmaz egy vagy több további hatóanyagot a giikopirrolát mellett. 4. A 3. igénypont szerinti kiszerelés, ahol az egy vagy több további hatóanyag egy ß~2 agonisía, szteroidok, anh'kolinerg szerek és fosztodiészteráz-4 inhibitorok közül kerül kiválasztásra.
- 5. Az előz© igénypontok bármelyike szerinti kiszerelés, ahol a: kiszerelés olyan; csomagolásban van tárolva, amely kevesebb mint 10% nedvességtartatmu anyagból készült. β. Az δ. igénypont szerinti kiszerelés, ahoi a kiszerelés egy hidroxi-propil-metlí-celíuióz kapszulában van tárolva. ?. A i. Igénypont szerinti kiszerelés, ahöl a HPMG kapszulák egy leszigeteit kömyezitbln, mint például egy további fólia csomagoló rétegben vannak tarolva,
- 8. Az előző igihypöhfok bármelyike szerinti kiszerelés, ahol a kondicionáló lépéshez a rníkronizált glíkopirroiátot: a) egy tálcára helyezzük és adott esetben keverésnek vagy forgatásnak vetjük alá a kondicionálás során, hogy biztosítsuk, hogy valamennyi részecske azonos mértékben tegyen kitéve a: nedves atmoszférának; vagy b) egy floidizációs ágy rendszerbe helyezzük, adott esetben íiuidizáaós közeg jelenlétében.
- 9. Az előző Igénypontok bármelyike szerinti száraz por kiszerelés, ahol a kiszerelés olyan csomagolásban van tárolva, amely képes megelőzni nedvesség behatolását külső forrásokbóí, mint például ahol a csomagolás önmaga védett a külső forrásokból származó nedvesség behatolásával szemben.
- 10. Egy száraz por Inhalátor, amely egy elázó Igénypontok bármelyike szerinti száraz por kiszerelést tartalmaz.
- 11, Egy 1. igénypont szerinti száraz por kiszerelés antímuszkarin szerként történő alkalmazásra, adott esetben CÖED, asztma, cisztás fibrozis és rokon légúti betegségek kezelésére.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0409703.6A GB0409703D0 (en) | 2004-04-30 | 2004-04-30 | Pharmaceutical compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HUE025463T2 true HUE025463T2 (hu) | 2016-02-29 |
Family
ID=32408337
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HUE11190637A HUE025463T2 (hu) | 2004-04-30 | 2005-04-29 | Glikopirrolát és magnézium-sztearát száraz por kompozíciói |
| HUS1300006C HUS1300006I1 (hu) | 2004-04-30 | 2013-03-13 | Eljárás glikopirrolát száraz por készítmények elõállítására |
| HUS1500072C HUS1500072I1 (hu) | 2004-04-30 | 2015-12-21 | Glikopirrolát és magnézium-sztearát száraz por kompozíciói |
| HUS1500073C HUS1500073I1 (hu) | 2004-04-30 | 2015-12-21 | Glikopirrolát és magnézium-sztearát száraz por kompozíciói |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HUS1300006C HUS1300006I1 (hu) | 2004-04-30 | 2013-03-13 | Eljárás glikopirrolát száraz por készítmények elõállítására |
| HUS1500072C HUS1500072I1 (hu) | 2004-04-30 | 2015-12-21 | Glikopirrolát és magnézium-sztearát száraz por kompozíciói |
| HUS1500073C HUS1500073I1 (hu) | 2004-04-30 | 2015-12-21 | Glikopirrolát és magnézium-sztearát száraz por kompozíciói |
Country Status (27)
| Country | Link |
|---|---|
| US (1) | US20080063719A1 (hu) |
| EP (3) | EP2422766B1 (hu) |
| JP (2) | JP5000483B2 (hu) |
| KR (1) | KR101287919B1 (hu) |
| CN (3) | CN107252423A (hu) |
| AU (2) | AU2005237266B2 (hu) |
| BR (1) | BRPI0510500B8 (hu) |
| CA (1) | CA2563760C (hu) |
| CY (6) | CY1113069T1 (hu) |
| DK (2) | DK1755555T3 (hu) |
| ES (2) | ES2388289T3 (hu) |
| GB (1) | GB0409703D0 (hu) |
| HK (2) | HK1095282A1 (hu) |
| HU (4) | HUE025463T2 (hu) |
| IL (2) | IL178651A (hu) |
| LT (1) | LTC2422766I2 (hu) |
| LU (2) | LU92176I2 (hu) |
| MX (2) | MXPA06012493A (hu) |
| NO (1) | NO20065502L (hu) |
| NZ (1) | NZ550479A (hu) |
| PL (2) | PL2422766T3 (hu) |
| PT (2) | PT1755555E (hu) |
| RU (1) | RU2396943C2 (hu) |
| SG (3) | SG186673A1 (hu) |
| SI (2) | SI1755555T1 (hu) |
| WO (1) | WO2005105043A2 (hu) |
| ZA (1) | ZA200609350B (hu) |
Families Citing this family (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0409703D0 (en) | 2004-04-30 | 2004-06-02 | Vectura Ltd | Pharmaceutical compositions |
| GB0425758D0 (en) | 2004-11-23 | 2004-12-22 | Vectura Ltd | Preparation of pharmaceutical compositions |
| GB0525254D0 (en) * | 2005-12-12 | 2006-01-18 | Jagotec Ag | Powder compositions for inhalation |
| GB0613161D0 (en) | 2006-06-30 | 2006-08-09 | Novartis Ag | Organic Compounds |
| GB0622818D0 (en) * | 2006-11-15 | 2006-12-27 | Jagotec Ag | Improvements in or relating to organic compounds |
| EP2234595B1 (en) * | 2007-12-13 | 2012-11-28 | Novartis AG | Process for reducing the tendency of a glycopyyronium salt to aggegate during storage. |
| CA2707594C (en) * | 2007-12-13 | 2015-08-18 | Novartis Ag | Process for preparing particulates of crystalline drug substance |
| US20100055045A1 (en) | 2008-02-26 | 2010-03-04 | William Gerhart | Method and system for the treatment of chronic obstructive pulmonary disease with nebulized anticholinergic administrations |
| GB2468073B (en) * | 2008-02-26 | 2012-09-05 | Elevation Pharmaceuticals Inc | Method and system for the treatment of chronic obstructive pulmonary disease with nebulized anticholinergic administrations |
| WO2010097115A1 (en) | 2009-02-26 | 2010-09-02 | Glaxo Group Limited | Pharmaceutical formulations comprising 4-{(1r)-2- [(6-{2-[(2,6-dichlorobenzyl)oxy] ethoxy}hexyl)amino]-1-hydroxyethyl}-2- (hydroxymethyl)phenol |
| CA2759041A1 (en) * | 2009-04-24 | 2010-10-28 | Schering Corporation | Agglomerate formulations useful in dry powder inhalers |
| GB0921075D0 (en) | 2009-12-01 | 2010-01-13 | Glaxo Group Ltd | Novel combination of the therapeutic agents |
| GB0921481D0 (en) * | 2009-12-08 | 2010-01-20 | Vectura Ltd | Process and product |
| EP2552414A4 (en) * | 2010-03-31 | 2014-05-14 | Glenmark Pharmaceuticals Ltd | PHARMACEUTICAL POWDER COMPOSITION FOR INHALATION |
| BR112012024059B1 (pt) | 2010-04-01 | 2021-06-01 | Chiesi Farmaceutici S.P.A. | Processo de preparo de um excipiente para composições farmacêuticas em pó para inalação, partículas carreadoras para uma formulação farmacêutica de pó seco, composição farmacêutica em forma de pó seco para inalação e inalador de pó seco |
| ES2658179T3 (es) | 2010-04-21 | 2018-03-08 | Chiesi Farmaceutici S.P.A. | Procedimiento para proporcionar partículas con cargas electrostáticas reducidas |
| US20130157991A1 (en) | 2010-08-31 | 2013-06-20 | Osama Ahmed Aswania | Dry Powder Inhalation Drug Products Exhibiting Moisture Control Properties and Methods of Administering the Same |
| EP3461474B1 (en) | 2010-08-31 | 2020-11-11 | GlaxoSmithKline Intellectual Property Development Limited | Dry powder inhalation drug products exhibiting moisture control properties and methods of administering the same |
| JO3510B1 (ar) * | 2011-03-04 | 2020-07-05 | Heptares Therapeutics Ltd | استخدام جلايكوبيرولات لعلاج عدم انتظام دقات القلب |
| WO2013153146A1 (en) | 2012-04-13 | 2013-10-17 | Glaxosmithkline Intellectual Property Development Limited | Aggregate particles |
| AU2013100007B4 (en) * | 2013-01-04 | 2013-05-23 | Novartis Ag | System for treating chronic obstructive pulmonary disease |
| EP3842419B1 (en) | 2013-02-28 | 2024-04-03 | Journey Medical Corporation | Method of making threo glycopyrrolate tosylate |
| US8558008B2 (en) | 2013-02-28 | 2013-10-15 | Dermira, Inc. | Crystalline glycopyrrolate tosylate |
| US9006462B2 (en) | 2013-02-28 | 2015-04-14 | Dermira, Inc. | Glycopyrrolate salts |
| ES2712988T5 (es) * | 2013-03-15 | 2022-10-21 | Pearl Therapeutics Inc | Métodos y sistemas para acondicionamiento de materiales cristalinos en partículas |
| GB201305825D0 (en) | 2013-03-28 | 2013-05-15 | Vectura Ltd | New use |
| US9393202B2 (en) * | 2013-04-26 | 2016-07-19 | Chiesi Farmaceutici S.P.A | Particle size reduction of an antimuscarinic compound |
| GB201402556D0 (en) | 2014-02-13 | 2014-04-02 | Crystec Ltd | Improvements relating to inhalable particles |
| PT3191081T (pt) | 2014-09-09 | 2020-05-29 | Vectura Ltd | Formulação que compreende glicopirrolato, método e equipamento |
| EP3206668A1 (en) | 2014-10-16 | 2017-08-23 | Teva Branded Pharmaceutical Products R & D, Inc. | Dry powder formulation |
| US9925168B2 (en) * | 2016-01-22 | 2018-03-27 | Chiesi Farmaceutici S.P.A. | Preparation of micronized particles of an antimuscarinic compound by hydrodynamic cavitation |
| JP6741774B2 (ja) | 2016-03-08 | 2020-08-19 | メレオ バイオファーマ １ リミテッド | 慢性閉塞性肺疾患の急性増悪の治療のための投与レジメン |
| BR112018067784A2 (pt) | 2016-03-08 | 2019-01-15 | Mereo Biopharma 1 Ltd | regime de dosagem para o tratamento de exacerbações agudas de condições inflamatórias |
| PL3490533T3 (pl) | 2016-07-29 | 2020-11-02 | Inke, S.A. | Sposób stabilizacji rozmiaru cząstek |
| EP3610871B1 (en) | 2016-09-19 | 2023-11-08 | Mexichem Fluor S.A. de C.V. | Pharmaceutical composition comprising glycopyrrolate |
| EP3595631A1 (en) | 2017-03-15 | 2020-01-22 | Vectura Limited | Method and formulation |
| WO2019060604A1 (en) * | 2017-09-20 | 2019-03-28 | Teva Branded Pharmaceutical Products R&D, Inc. | INHALABLE MEDICINE |
| WO2019060595A1 (en) | 2017-09-20 | 2019-03-28 | Teva Branded Pharmaceutical Products R&D, Inc. | INHALABLE DRY POWDER MEDICINAL PRODUCT COMPRISING GLYCOPYRRONIUM |
| WO2019116022A1 (en) | 2017-12-11 | 2019-06-20 | Mereo Biopharma 1 Limited | Use of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-n-cyclopropyl-4-methylbenzamide in the prevention or reduction of acute exacerbations of chronic obstructive pulmonary disease |
| HUE055425T2 (hu) | 2017-12-11 | 2021-11-29 | Mereo Biopharma 1 Ltd | 3-[5-amino-4-(3-cianobenzoil)-pirazol-1-il]-N-ciklopropil-4-metilbenzamid alkalmazása krónikus elzáródásos tüdõbetegség akut fokozódásának kezelésében |
| KR102696616B1 (ko) | 2018-12-21 | 2024-08-20 | 한미약품 주식회사 | 흡입 제형용 건조 분말 및 이의 제조방법 |
| EP4452222A1 (en) | 2021-12-21 | 2024-10-30 | Chiesi Farmaceutici S.p.A. | Dry powder formulations filled in an inhaler with improved resistance to humidity |
| WO2023117985A1 (en) | 2021-12-21 | 2023-06-29 | Chiesi Farmaceutici S.P.A. | Dry powder formulations filled in an inhaler with improved resistance to humidity |
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| GB9826286D0 (en) | 1998-12-01 | 1999-01-20 | Rhone Poulence Rorer Limited | Process |
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| GB0008660D0 (en) * | 2000-04-07 | 2000-05-31 | Arakis Ltd | The treatment of respiratory diseases |
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| ES2292598T3 (es) | 2000-06-27 | 2008-03-16 | Vectura Limited | Metodo para producir particulas para usar en una composicion farmaceutica. |
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| KR20050003416A (ko) * | 2002-05-07 | 2005-01-10 | 넥타르 테라퓨틱스 | 건조분말 흡입기용 캡슐 및 이의 제조 및 사용 방법 |
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| GB0409703D0 (en) | 2004-04-30 | 2004-06-02 | Vectura Ltd | Pharmaceutical compositions |
| JP2008534480A (ja) * | 2005-03-24 | 2008-08-28 | ソーセイ アールアンドディ リミテッド | グリコピロニウム塩およびそれらの治療的使用 |
-
2004
- 2004-04-30 GB GBGB0409703.6A patent/GB0409703D0/en not_active Ceased
-
2005
- 2005-04-29 CN CN201710357916.6A patent/CN107252423A/zh active Pending
- 2005-04-29 JP JP2007510045A patent/JP5000483B2/ja active Active
- 2005-04-29 ES ES05738040T patent/ES2388289T3/es active Active
- 2005-04-29 BR BRPI0510500A patent/BRPI0510500B8/pt active IP Right Grant
- 2005-04-29 CA CA2563760A patent/CA2563760C/en active Active
- 2005-04-29 DK DK05738040.4T patent/DK1755555T3/da active
- 2005-04-29 PT PT05738040T patent/PT1755555E/pt unknown
- 2005-04-29 PL PL11190637T patent/PL2422766T3/pl unknown
- 2005-04-29 CN CNA200580013592XA patent/CN1964700A/zh active Pending
- 2005-04-29 PL PL05738040T patent/PL1755555T3/pl unknown
- 2005-04-29 AU AU2005237266A patent/AU2005237266B2/en active Active
- 2005-04-29 SI SI200531570T patent/SI1755555T1/sl unknown
- 2005-04-29 NZ NZ550479A patent/NZ550479A/en unknown
- 2005-04-29 HU HUE11190637A patent/HUE025463T2/hu unknown
- 2005-04-29 ES ES11190637.6T patent/ES2546982T3/es active Active
- 2005-04-29 RU RU2006142322/15A patent/RU2396943C2/ru active Protection Beyond IP Right Term
- 2005-04-29 SG SG2012093886A patent/SG186673A1/en unknown
- 2005-04-29 WO PCT/EP2005/051980 patent/WO2005105043A2/en active Application Filing
- 2005-04-29 KR KR1020067024763A patent/KR101287919B1/ko active IP Right Grant
- 2005-04-29 DK DK11190637.6T patent/DK2422766T3/da active
- 2005-04-29 SI SI200531999T patent/SI2422766T1/sl unknown
- 2005-04-29 EP EP11190637.6A patent/EP2422766B1/en not_active Revoked
- 2005-04-29 PT PT111906376T patent/PT2422766E/pt unknown
- 2005-04-29 EP EP11190638A patent/EP2422767A3/en not_active Withdrawn
- 2005-04-29 EP EP05738040A patent/EP1755555B1/en not_active Revoked
- 2005-04-29 CN CN2010105642463A patent/CN102008453A/zh active Pending
- 2005-04-29 MX MXPA06012493A patent/MXPA06012493A/es active IP Right Grant
- 2005-04-29 SG SG10201605001SA patent/SG10201605001SA/en unknown
- 2005-04-29 US US11/587,725 patent/US20080063719A1/en not_active Abandoned
- 2005-04-29 SG SG200903001-6A patent/SG152292A1/en unknown
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2006
- 2006-10-16 IL IL178651A patent/IL178651A/en active IP Right Review Request
- 2006-10-27 MX MX2012008068A patent/MX341426B/es unknown
- 2006-11-10 ZA ZA2006/09350A patent/ZA200609350B/en unknown
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