JP6004233B2 - ホスホジエステラーゼ阻害剤を含む乾燥粉末製剤 - Google Patents
ホスホジエステラーゼ阻害剤を含む乾燥粉末製剤 Download PDFInfo
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- JP6004233B2 JP6004233B2 JP2013522202A JP2013522202A JP6004233B2 JP 6004233 B2 JP6004233 B2 JP 6004233B2 JP 2013522202 A JP2013522202 A JP 2013522202A JP 2013522202 A JP2013522202 A JP 2013522202A JP 6004233 B2 JP6004233 B2 JP 6004233B2
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- dry powder
- powder formulation
- inhalable dry
- particles
- inhalable
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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
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- 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
- A61K9/141—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
- A61K9/14—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
-
- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Description
用語「活性薬物」、「活性成分」、「活性」および「活性物質」、「活性化合物」、ならびに「治療薬」は、同義語として使用する。
nは0または1であり、
R1およびR2は同じかまたは異なっていてもよく、下記から成る群:
−1以上のハロゲン原子で必要に応じて置換される直鎖状または分岐状の(C1−C6)アルキル、
−OR3、(R3は1以上のハロゲン原子またはC3−C7シクロアルキル基で必要に応じて置換される直鎖状または分岐状の(C1−C6)アルキルである)、および
−HNSO2R4、(R4は1以上のハロゲン原子で必要に応じて置換される直鎖状または分岐状の(C1−C4)アルキルである)、
より選択され、
式中、R1およびR2のうちの少なくとも1つはHNSO2R4である]
および、生理学的に許容される薬理学的に不活性な固体担体の粒子を含む、吸入可能な乾燥粉末形態の医薬製剤である。
i)10%以下の粒子は0.8ミクロン未満の質量径を有する。
ii)50%以下の粒子は1.7ミクロン未満、好ましくは1.8〜2.5ミクロンの間を含む質量径を有する。
iii)少なくとも90%の粒子は6ミクロン未満の質量径を有する。
i)活性成分および担体を共に微粉化する段階、
ii)得られた共微粉化混合物を凝集および球形化させる段階。
i)活性成分および担体を別々に微粉化する段階、
ii)微粉化成分を混合する段階、および
iii)得られた混合物を凝集および球形化させる段階。
i)微粉化形態の一般式(I)の化合物の粒子、
ii)生理学的に許容される薬理学的に不活性な物質の粒子および添加物質の粒子から成る混合物で構成される微粒子の画分、前記微粒子は10ミクロンに等しいかそれ未満、好ましくは6ミクロンに等しいかそれ未満のMMDを有する、および
iii)非常に亀裂の多い表面、および150ミクロン〜400ミクロンの間、好ましくは212〜355ミクロンの間を含む質量径(MD)を有する生理学的に許容される薬理学的に不活性な物質の粒子の画分。
a)生理学的に許容される薬理学的に不活性な物質で作成された粒子および添加物の粒子から成る混合物で構成される微粒子を調製する段階、ここで不活性物質および添加物は最初に混合し、次いで共微粉化する、
b)段階a)の微粒子を生理学的に許容される薬理学的に不活性な物質の粗粒子と混合することで、微粒子が粗粒子の表面に接着する段階、
c)微粉化形態の活性粒子を段階b)の粒子に混合して添加する段階。
実施例
本発明による粉末製剤は表1に報告する組成を有する。
表1
表2
実施例1と同様の組成を有するが、単一の組成、すなわち表3に報告する吸入器のショット当たりの組成を有する粉末製剤を調製した。
表3
表4
実施例1または実施例2と同様の組成を有する粉末製剤を、異なる強度および割合の共微粉化粒子を用いて調製した。
表5
本発明によるさらなる粉末製剤を、表6および7で報告する組成で調製する。
表6
本発明の好ましい化合物の1つの効力を、Eur J Pharmacol 2002 Feb 22;437(3):187−94の記載に軽微な変更を加えた方法に従って、肺炎症の急性モデルを用いて生体内にて評価した。
Claims (10)
- (−)−3−シクロプロピルメトキシ−4−メタンスルホニルアミノ−安息香酸1−(3−シクロプロピルメトキシ−4−ジフルオロメトキシ−フェニル)−2−(3,5−ジクロロ−1−オキシ−ピリジン−4−イル)−エチルエステルの微細化粒子から成る有効成分および、
質量径が150〜400ミクロンのα−ラクトース一水和物粗粒子、質量中央計(MMD)が10ミクロンに等しいかそれ未満のα−ラクトース一水和物微細化粒子、およびステアリン酸マグネシウムの混合物から構成される粒子担体
を含む吸入可能な乾燥粉末製剤であって
前記有効成分の、単回用量が10〜2000μgの間を含む、吸入可能な乾燥粉末製剤。 - 請求項1に記載の吸入可能な乾燥粉末製剤であって、前記単回用量は20μg〜1000μgの間を含む吸入可能な乾燥粉末製剤。
- 請求項2に記載の吸入可能な乾燥粉末製剤であって、前記単回用量は50μg〜800μgの間を含む吸入可能な乾燥粉末製剤。
- 請求項3に記載の吸入可能な乾燥粉末製剤であって、前記単回用量は100μg〜600μgの間を含む吸入可能な乾燥粉末製剤。
- 請求項4に記載の吸入可能な乾燥粉末製剤であって、前記単回用量、100μg、200μg、400μg、または600μgである吸入可能な乾燥粉末製剤。
- 請求項1〜5のうちいずれか一項に記載の吸入可能な乾燥粉末製剤であって、前記ステアリン酸マグネシウムは吸入可能な乾燥粉末製剤の総重量に対して0.01〜2重量%を含む量で存在する吸入可能な乾燥粉末製剤。
- 請求項6に記載の吸入可能な乾燥粉末製剤であって、前記ステアリン酸マグネシウムの量は0.02〜1%w/wの間を含む吸入可能な乾燥粉末製剤。
- 請求項1〜7のうちいずれか一項に記載の吸入可能な乾燥粉末製剤を含む乾燥粉末吸入器。
- 喘息および慢性閉塞性肺疾患(COPD)などの呼吸器疾患を予防および/または治療するための使用に対する、請求項1〜7のうちいずれか一項に記載の吸入可能な乾燥粉末製剤。
- 請求項1〜7または請求項9のうちいずれか一項に記載の吸入可能な乾燥粉末製剤および乾燥粉末吸入器を含む箱。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10171748 | 2010-08-03 | ||
EP10171748.6 | 2010-08-03 | ||
PCT/EP2011/062872 WO2012016889A2 (en) | 2010-08-03 | 2011-07-27 | Dry powder formulation comprising a phosphodiesterase inhibitor |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2013532705A JP2013532705A (ja) | 2013-08-19 |
JP6004233B2 true JP6004233B2 (ja) | 2016-10-05 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013522202A Active JP6004233B2 (ja) | 2010-08-03 | 2011-07-27 | ホスホジエステラーゼ阻害剤を含む乾燥粉末製剤 |
Country Status (36)
Country | Link |
---|---|
US (2) | US9132121B2 (ja) |
EP (2) | EP3246016A1 (ja) |
JP (1) | JP6004233B2 (ja) |
KR (1) | KR101805958B1 (ja) |
CN (2) | CN103052379A (ja) |
AR (1) | AR082443A1 (ja) |
AU (1) | AU2011287711B2 (ja) |
BR (1) | BR112013002506A2 (ja) |
CA (1) | CA2807256C (ja) |
CL (1) | CL2013000293A1 (ja) |
CO (1) | CO6690744A2 (ja) |
CY (1) | CY1120605T1 (ja) |
DK (1) | DK2600830T3 (ja) |
EA (2) | EA027692B1 (ja) |
ES (1) | ES2664175T3 (ja) |
GE (1) | GEP20156343B (ja) |
HR (1) | HRP20180717T1 (ja) |
HU (1) | HUE037620T2 (ja) |
IL (1) | IL224517B (ja) |
LT (1) | LT2600830T (ja) |
MA (1) | MA34449B1 (ja) |
ME (1) | ME03022B (ja) |
MX (1) | MX346424B (ja) |
MY (1) | MY179703A (ja) |
NO (1) | NO2600830T3 (ja) |
NZ (1) | NZ606548A (ja) |
PE (2) | PE20171256A1 (ja) |
PL (1) | PL2600830T3 (ja) |
PT (1) | PT2600830T (ja) |
RS (1) | RS57061B1 (ja) |
SG (1) | SG187258A1 (ja) |
SI (1) | SI2600830T1 (ja) |
TR (1) | TR201807012T4 (ja) |
UA (1) | UA112296C2 (ja) |
WO (1) | WO2012016889A2 (ja) |
ZA (1) | ZA201300870B (ja) |
Cited By (2)
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KR101859750B1 (ko) * | 2017-09-13 | 2018-05-21 | 제일에스엠피(주) | 고정식 열 저장 운반장치 |
KR101859752B1 (ko) * | 2017-09-13 | 2018-05-21 | 심원 | 조립식 열 저장 운반장치 |
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US8506934B2 (en) | 2005-04-29 | 2013-08-13 | Robert I. Henkin | Methods for detection of biological substances |
WO2008095136A2 (en) | 2007-01-31 | 2008-08-07 | Henkin Robert I | Methods for detection of biological substances |
EP2022783A1 (en) | 2007-08-08 | 2009-02-11 | CHIESI FARMACEUTICI S.p.A. | "Derivatives of 1-phenyl-2-pyridinyl alkyl alcohols as phosphodiesterase inhibitors" |
US8580801B2 (en) | 2008-07-23 | 2013-11-12 | Robert I. Henkin | Phosphodiesterase inhibitor treatment |
EP2216327A1 (en) | 2009-02-06 | 2010-08-11 | CHIESI FARMACEUTICI S.p.A. | Benzoic acid (1-phenyl-2-pyridin-4-yl)ethyl esters as phosphodiesterase inhibitors |
EP2600829B1 (en) | 2010-08-03 | 2017-06-14 | Chiesi Farmaceutici S.p.A. | Pharmaceutical formulation comprising a phosphodiesterase inhibitor |
WO2012168226A1 (en) | 2011-06-06 | 2012-12-13 | Chiesi Farmaceutici S.P.A. | Derivatives of 1-phenyl-2-pyridinyl alkyl alcohols as phosphodiesterase inhibitors |
EP2916868B1 (en) | 2012-11-08 | 2022-05-11 | Rhizen Pharmaceuticals S.A. | Pharmaceutical compositions containing a pde4 inhibitor and a pi3 delta or dual pi3 delta-gamma kinase inhibitor |
US20160030435A1 (en) * | 2013-03-15 | 2016-02-04 | Robert I HENKIN | Phosphodiesterase inhibitor treatment |
US9427376B2 (en) * | 2013-10-10 | 2016-08-30 | Chiesi Farmaceutici S.P.A. | Process for preparing pharmaceutical formulations for inhalation comprising a high-dosage strength active ingredient |
HUE046637T2 (hu) | 2013-10-22 | 2020-03-30 | Chiesi Farm Spa | Eljárás PDE4-inhibitor elõállítására |
GB201321717D0 (en) * | 2013-12-09 | 2014-01-22 | Pharmachemie Bv | Inhalable Medicaments |
WO2015089105A1 (en) | 2013-12-09 | 2015-06-18 | Respira Therapeutics, Inc. | Pde5 inhibitor powder formulations and methods relating thereto |
CN104800192A (zh) * | 2014-01-27 | 2015-07-29 | 成都英诺新科技有限公司 | 一种罗氟司特吸入粉雾剂及制备方法 |
WO2015126944A1 (en) | 2014-02-18 | 2015-08-27 | Henkin Robert I | Methods and compositions for diagnosing and treating loss and/or distortion of taste or smell |
US20180021256A1 (en) | 2014-07-09 | 2018-01-25 | Arven Ilac Sanayi Ve Ticaret A.S. | Process for the preparation of formulations for inhalation |
WO2017089347A1 (en) | 2015-11-25 | 2017-06-01 | Inserm (Institut National De La Sante Et De La Recherche Medicale) | Methods and pharmaceutical compositions for the treatment of braf inhibitor resistant melanomas |
US10583085B2 (en) * | 2017-05-17 | 2020-03-10 | Chiesi Farmaceutici S.P.A. | Carrier particles for dry powder formulations for inhalation |
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 |
WO2023208982A1 (en) | 2022-04-27 | 2023-11-02 | Chiesi Farmaceutici S.P.A. | Crystal form of a pde4 inhibitor |
WO2024027901A1 (en) | 2022-08-02 | 2024-02-08 | Chiesi Farmaceutici S.P.A. | Predictive biomarker of clinical response to a pde4 inhibitor |
WO2024062005A1 (en) | 2022-09-22 | 2024-03-28 | Chiesi Farmaceutici S.P.A. | Capsule inhaler for the administration of a phosphodiesterase-4 inhibitor |
WO2024062006A1 (en) | 2022-09-22 | 2024-03-28 | Chiesi Farmaceutici S.P.A. | Capsule inhaler for the administration of a phosphodiesterase-4 inhibitor |
WO2024062007A1 (en) | 2022-09-22 | 2024-03-28 | Chiesi Farmaceutici S.P.A. | Capsule inhaler for the administration of a phosphodiesterase-4 inhibitor |
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DK1386630T3 (da) | 2002-07-31 | 2006-09-11 | Chiesi Farma Spa | Pulverinhalator |
DE10255387A1 (de) * | 2002-11-28 | 2004-06-09 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Neue Tiotropium-haltige Pulverformulierung für die Inhalation |
GB0326632D0 (en) * | 2003-11-14 | 2003-12-17 | Jagotec Ag | Dry powder formulations |
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BRPI0610877A2 (pt) * | 2005-06-06 | 2010-08-03 | Hoffmann La Roche | compostos, processo para a manufatura dos compostos, composições farmacêuticas que os compreendem, método para o tratamento terapêutico e/ou profilático de enfermidades que são moduladas por inibidores de l-cpt1 e utilização dos mesmos |
GB0613161D0 (en) * | 2006-06-30 | 2006-08-09 | Novartis Ag | Organic Compounds |
EP2022783A1 (en) * | 2007-08-08 | 2009-02-11 | CHIESI FARMACEUTICI S.p.A. | "Derivatives of 1-phenyl-2-pyridinyl alkyl alcohols as phosphodiesterase inhibitors" |
EP2070913A1 (en) * | 2007-12-14 | 2009-06-17 | CHIESI FARMACEUTICI S.p.A. | Ester derivatives as phosphodiesterase inhibitors |
EP2216327A1 (en) * | 2009-02-06 | 2010-08-11 | CHIESI FARMACEUTICI S.p.A. | Benzoic acid (1-phenyl-2-pyridin-4-yl)ethyl esters as phosphodiesterase inhibitors |
EP2600829B1 (en) | 2010-08-03 | 2017-06-14 | Chiesi Farmaceutici S.p.A. | Pharmaceutical formulation comprising a phosphodiesterase inhibitor |
WO2012168226A1 (en) | 2011-06-06 | 2012-12-13 | Chiesi Farmaceutici S.P.A. | Derivatives of 1-phenyl-2-pyridinyl alkyl alcohols as phosphodiesterase inhibitors |
HUE046637T2 (hu) | 2013-10-22 | 2020-03-30 | Chiesi Farm Spa | Eljárás PDE4-inhibitor elõállítására |
-
2011
- 2011-07-27 MY MYPI2013000339A patent/MY179703A/en unknown
- 2011-07-27 SG SG2013008107A patent/SG187258A1/en unknown
- 2011-07-27 PT PT117411728T patent/PT2600830T/pt unknown
- 2011-07-27 EA EA201690541A patent/EA027692B1/ru unknown
- 2011-07-27 TR TR2018/07012T patent/TR201807012T4/tr unknown
- 2011-07-27 DK DK11741172.8T patent/DK2600830T3/en active
- 2011-07-27 JP JP2013522202A patent/JP6004233B2/ja active Active
- 2011-07-27 PE PE2017001245A patent/PE20171256A1/es unknown
- 2011-07-27 BR BR112013002506A patent/BR112013002506A2/pt not_active Application Discontinuation
- 2011-07-27 RS RS20180394A patent/RS57061B1/sr unknown
- 2011-07-27 EP EP17176635.5A patent/EP3246016A1/en active Pending
- 2011-07-27 LT LTEP11741172.8T patent/LT2600830T/lt unknown
- 2011-07-27 PL PL11741172T patent/PL2600830T3/pl unknown
- 2011-07-27 PE PE2013000155A patent/PE20130601A1/es active IP Right Grant
- 2011-07-27 KR KR1020137002872A patent/KR101805958B1/ko active IP Right Grant
- 2011-07-27 UA UAA201302607A patent/UA112296C2/uk unknown
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KR101859750B1 (ko) * | 2017-09-13 | 2018-05-21 | 제일에스엠피(주) | 고정식 열 저장 운반장치 |
KR101859752B1 (ko) * | 2017-09-13 | 2018-05-21 | 심원 | 조립식 열 저장 운반장치 |
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