JP6170460B2 - 新規薬用量および製剤 - Google Patents
新規薬用量および製剤 Download PDFInfo
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- JP6170460B2 JP6170460B2 JP2014078703A JP2014078703A JP6170460B2 JP 6170460 B2 JP6170460 B2 JP 6170460B2 JP 2014078703 A JP2014078703 A JP 2014078703A JP 2014078703 A JP2014078703 A JP 2014078703A JP 6170460 B2 JP6170460 B2 JP 6170460B2
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- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
-
- 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
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
-
- 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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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
典型例として、該アクリジニウムはアニオンX(ただし、Xは薬学的に許容される一価または多価酸のアニオンである)との塩の形状で投与する。さらに典型的には、Xは無機酸、例えば、塩酸、臭化水素酸、硫酸およびリン酸、または有機酸、例えば、メタンスルホン酸、酢酸、フマル酸、コハク酸、乳酸、クエン酸もしくはマレイン酸などに由来するアニオンである。好ましくは、該アクリジニウムは臭化アクリジニウムの形状である。
あるいは、該有効成分は添加剤なしに提供し得る。
Claims (13)
- 喘息および慢性閉塞性肺疾患から選択される呼吸器系症状の処置のための、薬学的に許容される乾燥粉末担体と混合したアクリジニウムまたはその薬学的に許容される塩を含有する、吸入用の乾燥粉末製剤形状の医薬組成物であって、(a) 400マイクログラム(±10%)の臭化アクリジニウムに相当する計量公称薬用量のアクリジニウム、(b) 360マイクログラム(±35%)の臭化アクリジニウムに相当する放出薬用量のアクリジニウム、または (c) 120マイクログラム(±35%)の臭化アクリジニウムに相当する微粒子薬用量のアクリジニウムを提供する量で1日1回または2回投与される医薬組成物。
- (a) 400マイクログラム(±10%)の臭化アクリジニウムに相当する単回計量公称薬用量のアクリジニウム、(b) 360マイクログラム(±35%)の臭化アクリジニウムに相当する単回放出薬用量のアクリジニウム、または (c) 120マイクログラム(±35%)の臭化アクリジニウムに相当する単回微粒子薬用量のアクリジニウムを提供する、単回投与乾燥粉末製剤形状の請求項1記載の医薬組成物。
- (a) 400マイクログラム(±10%)の臭化アクリジニウムに相当する計量公称薬用量のアクリジニウム、(b) 360マイクログラム(±35%)の臭化アクリジニウムに相当する放出薬用量のアクリジニウム、または (c) 120マイクログラム(±35%)の臭化アクリジニウムに相当する微粒子薬用量のアクリジニウムを提供するように目盛りを付けた多回投与乾燥粉末吸入装置中の、多回投与乾燥粉末製剤形状の請求項1記載の医薬組成物。
- アクリジニウムの薬学的に許容される塩が、臭化アクリジニウムである、請求項1〜3のいずれかに記載の医薬組成物。
- 薬学的に許容される担体が、ラクトース粒子である、請求項1〜4のいずれかに記載の医薬組成物。
- アクリジニウムと担体の重量比が、1:25ないし1:75である、請求項1〜5のいずれかに記載の医薬組成物。
- アクリジニウムの平均粒子直径が2〜5μm以内である、請求項1〜6のいずれかに記載の医薬組成物。
- 担体粒子が、90〜160μmのd10、170〜270μmのd50、および290〜400μmのd90を有する、請求項1〜7のいずれかに記載の医薬組成物。
- さらに、β2−アゴニスト、PDE IVインヒビター、およびコルチコステロイドから選択される1種以上のさらなる活性薬剤の有効量を含有してなる請求項1〜8のいずれかに記載の医薬組成物。
- さらなる活性薬剤が、遊離形状または薬学的に許容される塩の形状のフォルモテロール、サルメテロール、ブデソニド、フルチカゾン、およびモメタゾンから選択されるものである、請求項9記載の医薬組成物。
- さらなる活性薬剤が、1計量公称薬用量につき5〜25マイクログラムの量のフマル酸フォルモテロールである、請求項10記載の医薬組成物。
- 請求項1〜11のいずれかに記載の医薬組成物の製造における、遊離形または薬学的に許容される塩形態のアクリジニウムの使用。
- (a) 400マイクログラム(±10%)の臭化アクリジニウムに相当する計量公称薬用量のアクリジニウム、(b) 360マイクログラム(±35%)の臭化アクリジニウムに相当する放出薬用量のアクリジニウム、または (c) 120マイクログラム(±35%)の臭化アクリジニウムに相当する微粒子薬用量のアクリジニウムを作動時に送達するように目盛り付けした、請求項1〜11のいずれかに記載の医薬組成物を投与するための多回投与乾燥粉末吸入装置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08382010.0 | 2008-03-13 | ||
EP08382010A EP2100599A1 (en) | 2008-03-13 | 2008-03-13 | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010550092A Division JP2011513451A (ja) | 2008-03-13 | 2009-03-13 | 新規薬用量および製剤 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2016052576A Division JP2016130248A (ja) | 2008-03-13 | 2016-03-16 | 新規薬用量および製剤 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2014139233A JP2014139233A (ja) | 2014-07-31 |
JP6170460B2 true JP6170460B2 (ja) | 2017-07-26 |
Family
ID=39645012
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010550092A Withdrawn JP2011513451A (ja) | 2008-03-13 | 2009-03-13 | 新規薬用量および製剤 |
JP2014078703A Active JP6170460B2 (ja) | 2008-03-13 | 2014-04-07 | 新規薬用量および製剤 |
JP2016052576A Pending JP2016130248A (ja) | 2008-03-13 | 2016-03-16 | 新規薬用量および製剤 |
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JP2010550092A Withdrawn JP2011513451A (ja) | 2008-03-13 | 2009-03-13 | 新規薬用量および製剤 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2016052576A Pending JP2016130248A (ja) | 2008-03-13 | 2016-03-16 | 新規薬用量および製剤 |
Country Status (37)
Country | Link |
---|---|
US (3) | US20110020412A1 (ja) |
EP (5) | EP2100599A1 (ja) |
JP (3) | JP2011513451A (ja) |
KR (3) | KR20100126322A (ja) |
CN (2) | CN102083416A (ja) |
AR (1) | AR070835A1 (ja) |
AU (1) | AU2009224895B9 (ja) |
BR (1) | BRPI0905775B1 (ja) |
CA (1) | CA2716724C (ja) |
CL (1) | CL2009000602A1 (ja) |
CO (1) | CO6290636A2 (ja) |
CY (1) | CY1116926T1 (ja) |
DK (3) | DK2954889T3 (ja) |
EC (1) | ECSP10010300A (ja) |
ES (3) | ES2916831T3 (ja) |
FI (1) | FI2265257T4 (ja) |
HK (1) | HK1145815A1 (ja) |
HR (3) | HRP20151214T4 (ja) |
HU (3) | HUE027726T2 (ja) |
IL (3) | IL206354A0 (ja) |
LT (2) | LT2954889T (ja) |
ME (1) | ME02286B (ja) |
MX (2) | MX368774B (ja) |
MY (1) | MY177027A (ja) |
NZ (1) | NZ585857A (ja) |
PE (3) | PE20141036A1 (ja) |
PL (3) | PL2265257T5 (ja) |
PT (3) | PT2954891T (ja) |
RS (3) | RS63399B1 (ja) |
RU (3) | RU2608713C3 (ja) |
SG (1) | SG188825A1 (ja) |
SI (3) | SI2954889T1 (ja) |
TW (1) | TWI439296B (ja) |
UA (1) | UA101652C2 (ja) |
UY (1) | UY31687A1 (ja) |
WO (1) | WO2009112274A2 (ja) |
ZA (1) | ZA201003900B (ja) |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2165768B1 (es) | 1999-07-14 | 2003-04-01 | Almirall Prodesfarma Sa | Nuevos derivados de quinuclidina y composiciones farmaceuticas que los contienen. |
ES2298049B1 (es) | 2006-07-21 | 2009-10-20 | Laboratorios Almirall S.A. | Procedimiento para fabricar bromuro de 3(r)-(2-hidroxi-2,2-ditien-2-ilacetoxi)-1-(3-fenoxipropil)-1-azoniabiciclo (2.2.2) octano. |
EP2100598A1 (en) | 2008-03-13 | 2009-09-16 | Laboratorios Almirall, S.A. | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
EP2100599A1 (en) | 2008-03-13 | 2009-09-16 | Laboratorios Almirall, S.A. | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
EP2510928A1 (en) * | 2011-04-15 | 2012-10-17 | Almirall, S.A. | Aclidinium for use in improving the quality of sleep in respiratory patients |
EP2666465A1 (en) * | 2012-05-25 | 2013-11-27 | Almirall, S.A. | Novel dosage and formulation |
WO2014007772A2 (en) | 2012-07-05 | 2014-01-09 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Inhalation compositions comprising glucose anhydrous |
WO2014007767A1 (en) * | 2012-07-05 | 2014-01-09 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dry powder inhalers comprising a carrier other than lactose and a ternary component |
US20150202148A1 (en) * | 2012-07-05 | 2015-07-23 | Arven llac Sanayi Ve Ticaret Anonim Sirketi | Dry powder inhalers comprising a carrier other than lactose |
WO2014007771A2 (en) | 2012-07-05 | 2014-01-09 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Inhalation compositions comprising muscarinic receptor antagonist |
LT2931275T (lt) * | 2012-12-17 | 2022-06-27 | Almirall S.A. | Aklidiniumas, skirtas naudoti fizinio aktyvumo kasdieniniame gyvenime padidinimui pacientui, sergančiam lėtine obstrukcine plaučių liga |
CN105338965A (zh) * | 2013-04-29 | 2016-02-17 | 赛诺菲股份有限公司 | 可吸入药用组合物和含有该药用组合物的吸入器装置 |
EP2923702A1 (en) * | 2014-03-28 | 2015-09-30 | Universite De Liege | Composition of cyclodextrin with budesonide derivatives for treatment and prevention of pulmonary inflammatory disease |
US10864213B2 (en) | 2014-05-12 | 2020-12-15 | Verona Pharma Plc | Treatment |
CZ2015257A3 (cs) * | 2015-04-16 | 2016-10-26 | Zentiva, K.S. | Způsob pro zmenšování velikosti částic bromidu [(3R)-1-(3-fenoxypropyl)chinuklidin-1-ium-3-yl] 2-hydroxy-2,2-bis(2-thienyl)acetátu |
CN107823193B (zh) * | 2017-11-16 | 2021-02-05 | 广州迈达康医药科技有限公司 | 一种阿地溴铵吸入型粉雾剂及其制备方法 |
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2009
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- 2009-03-11 PE PE2009000357A patent/PE20091672A1/es not_active Application Discontinuation
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