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)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (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) | CN102008453A (hu) |
AU (2) | AU2005237266B2 (hu) |
BR (1) | BRPI0510500B8 (hu) |
CA (1) | CA2563760C (hu) |
CY (6) | CY1113069T1 (hu) |
DK (2) | DK1755555T3 (hu) |
ES (2) | ES2546982T3 (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) | SG10201605001SA (hu) |
SI (2) | SI2422766T1 (hu) |
WO (1) | WO2005105043A2 (hu) |
ZA (1) | ZA200609350B (hu) |
Families Citing this family (43)
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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 |
KR20100099281A (ko) * | 2007-12-13 | 2010-09-10 | 노파르티스 아게 | 유기 화합물 |
EP2229148B1 (en) * | 2007-12-13 | 2014-03-05 | Novartis AG | Process for preparing a particulate and crystalline drug substance |
US20090215734A1 (en) * | 2008-02-26 | 2009-08-27 | Elevation Pharmaceuticals, Inc. | Method and system for the treatment of chronic obstructive pulmonary disease with nebulized anticholinergic administrations |
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 |
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AU2010238641A1 (en) * | 2009-04-24 | 2011-11-10 | Merck Sharp & Dohme Corp. | 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 |
RU2012138909A (ru) * | 2010-03-31 | 2014-05-10 | Гленмарк Фармасьютикалс Лимитед | Фармацевтическая порошковая композиция для ингаляций |
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 |
KR101863523B1 (ko) | 2010-04-21 | 2018-05-31 | 키에시 파르마슈티시 엣스. 피. 에이. | 정전하가 감소된 입자를 제공하는 방법 |
AU2011298409B2 (en) | 2010-08-31 | 2013-11-21 | Glaxo Group Limited | Dry powder inhalation drug products exhibiting moisture control properties and methods of administering the same |
ES2546422T5 (es) | 2010-08-31 | 2023-01-20 | Glaxosmithkline Ip Dev Ltd | Productos medicinales de inhalación de polvo seco que presentan propiedades de control de la humedad y procedimientos de administración de los mismos |
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RU2666963C2 (ru) | 2012-04-13 | 2018-09-13 | Глаксосмитклайн Интеллекчуал Проперти Дивелопмент Лимитед | Агрегированные частицы |
AU2013100007B4 (en) * | 2013-01-04 | 2013-05-23 | Novartis Ag | System for treating chronic obstructive pulmonary disease |
KR102232806B1 (ko) | 2013-02-28 | 2021-03-29 | 더미라, 인코포레이티드 | 글리코피롤레이트 염 |
US9006462B2 (en) | 2013-02-28 | 2015-04-14 | Dermira, Inc. | Glycopyrrolate salts |
US8558008B2 (en) | 2013-02-28 | 2013-10-15 | Dermira, Inc. | Crystalline glycopyrrolate tosylate |
KR102391332B1 (ko) | 2013-03-15 | 2022-04-26 | 펄 테라퓨틱스 인코포레이티드 | 미립자 결정질 재료를 컨디셔닝하는 방법 및 시스템 |
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 |
UA115958C2 (uk) * | 2014-09-09 | 2018-01-10 | Вектура Лімітед | Препарат, що містить глікопіролат, спосіб та пристрій |
US9980904B2 (en) | 2014-10-16 | 2018-05-29 | 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 |
WO2017153701A1 (en) | 2016-03-08 | 2017-09-14 | Mereo Biopharma 1 Limited | Dosage regimen for the treatment of acute exacerbations of inflammatory conditions |
KR20180118667A (ko) | 2016-03-08 | 2018-10-31 | 메레오 바이오파마 1 리미티드 | 만성 폐쇄성 폐 질환의 급성 악화 치료를 위한 투약법 |
EP3490533B1 (en) | 2016-07-29 | 2020-05-27 | Inke, S.A. | Particle size stabilization process |
MY202069A (en) | 2016-09-19 | 2024-03-31 | Mexichem Fluor Sa De Cv | Pharmaceutical composition |
EP3595631A1 (en) * | 2017-03-15 | 2020-01-22 | Vectura Limited | Method and formulation |
WO2019060595A1 (en) | 2017-09-20 | 2019-03-28 | Teva Branded Pharmaceutical Products R&D, Inc. | INHALABLE DRY POWDER MEDICINAL PRODUCT COMPRISING GLYCOPYRRONIUM |
WO2019060604A1 (en) * | 2017-09-20 | 2019-03-28 | Teva Branded Pharmaceutical Products R&D, Inc. | INHALABLE MEDICINE |
ES2884789T3 (es) | 2017-12-11 | 2021-12-13 | Mereo Biopharma 1 Ltd | Uso de 3-[5-amino-4-(3-cianobenzoil)-pirazol-1-il]-N-ciclopropil-4-metilbenzamida en el tratamiento de exacerbaciones agudas de la enfermedad pulmonar obstructiva crónica |
PL3585383T3 (pl) | 2017-12-11 | 2021-07-05 | Mereo Biopharma 1 Limited | Zastosowanie 3-[5-amino-4-(3-cyjanobenzoilo)pirazol-1-ilo]- n-cyklopropylo- 4-metylobenzamidu w zapobieganiu ostrym zaostrzeniom przewlekłej obturacyjnej choroby płuc |
KR102696616B1 (ko) | 2018-12-21 | 2024-08-20 | 한미약품 주식회사 | 흡입 제형용 건조 분말 및 이의 제조방법 |
CN118475343A (zh) | 2021-12-21 | 2024-08-09 | 凯西制药公司 | 填充在具有改善的耐湿性的吸入器中的干粉制剂 |
CN118414147A (zh) | 2021-12-21 | 2024-07-30 | 凯西制药公司 | 填充在具有改善的耐湿性的吸入器中的干粉制剂 |
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GB0409703D0 (en) | 2004-04-30 | 2004-06-02 | Vectura Ltd | Pharmaceutical compositions |
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2004
- 2004-04-30 GB GBGB0409703.6A patent/GB0409703D0/en not_active Ceased
-
2005
- 2005-04-29 CA CA2563760A patent/CA2563760C/en active Active
- 2005-04-29 SI SI200531999T patent/SI2422766T1/sl unknown
- 2005-04-29 DK DK05738040.4T patent/DK1755555T3/da active
- 2005-04-29 RU RU2006142322/15A patent/RU2396943C2/ru active Protection Beyond IP Right Term
- 2005-04-29 WO PCT/EP2005/051980 patent/WO2005105043A2/en active Application Filing
- 2005-04-29 PT PT05738040T patent/PT1755555E/pt unknown
- 2005-04-29 ES ES11190637.6T patent/ES2546982T3/es active Active
- 2005-04-29 EP EP11190637.6A patent/EP2422766B1/en not_active Revoked
- 2005-04-29 SG SG10201605001SA patent/SG10201605001SA/en unknown
- 2005-04-29 MX MXPA06012493A patent/MXPA06012493A/es active IP Right Grant
- 2005-04-29 PL PL11190637T patent/PL2422766T3/pl unknown
- 2005-04-29 SI SI200531570T patent/SI1755555T1/sl unknown
- 2005-04-29 EP EP11190638A patent/EP2422767A3/en not_active Withdrawn
- 2005-04-29 CN CN2010105642463A patent/CN102008453A/zh active Pending
- 2005-04-29 KR KR1020067024763A patent/KR101287919B1/ko active IP Right Grant
- 2005-04-29 PT PT111906376T patent/PT2422766E/pt unknown
- 2005-04-29 US US11/587,725 patent/US20080063719A1/en not_active Abandoned
- 2005-04-29 NZ NZ550479A patent/NZ550479A/en unknown
- 2005-04-29 PL PL05738040T patent/PL1755555T3/pl unknown
- 2005-04-29 CN CNA200580013592XA patent/CN1964700A/zh active Pending
- 2005-04-29 DK DK11190637.6T patent/DK2422766T3/da active
- 2005-04-29 AU AU2005237266A patent/AU2005237266B2/en active Active
- 2005-04-29 CN CN201710357916.6A patent/CN107252423A/zh active Pending
- 2005-04-29 SG SG2012093886A patent/SG186673A1/en unknown
- 2005-04-29 HU HUE11190637A patent/HUE025463T2/hu unknown
- 2005-04-29 SG SG200903001-6A patent/SG152292A1/en unknown
- 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 EP EP05738040A patent/EP1755555B1/en not_active Revoked
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