JP2011509919A - チオトロピウムとサルメテロールと担体としてラクトースを含む新規な粉末状薬剤 - Google Patents
チオトロピウムとサルメテロールと担体としてラクトースを含む新規な粉末状薬剤 Download PDFInfo
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- JP2011509919A JP2011509919A JP2010517374A JP2010517374A JP2011509919A JP 2011509919 A JP2011509919 A JP 2011509919A JP 2010517374 A JP2010517374 A JP 2010517374A JP 2010517374 A JP2010517374 A JP 2010517374A JP 2011509919 A JP2011509919 A JP 2011509919A
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- powder
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- lactose
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Images
Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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
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- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
- A61M15/0025—Mouthpieces therefor with caps
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Pulmonology (AREA)
- Epidemiology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dispersion Chemistry (AREA)
- Otolaryngology (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102007034157 | 2007-07-21 | ||
| US5193308P | 2008-05-09 | 2008-05-09 | |
| PCT/EP2008/059465 WO2009013244A1 (de) | 2007-07-21 | 2008-07-18 | Neue pulverförmige arzneimittel enthaltend tiotropium und salmeterol sowie laktose als hilfsstoff |
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| UY (1) | UY31235A1 (enExample) |
| WO (1) | WO2009013244A1 (enExample) |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2004018440A (ja) * | 2002-06-14 | 2004-01-22 | Ss Pharmaceut Co Ltd | 粉末状吸入剤組成物 |
| JP2004505685A (ja) * | 2000-08-04 | 2004-02-26 | ミクロドラッグ アーゲー | 電気的粉末 |
| JP2006516135A (ja) * | 2002-12-20 | 2006-06-22 | ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト | チオトロピウム塩とキシナホ酸サルメテロールとを含む吸入用粉末医薬品 |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1340492A1 (en) * | 2002-03-01 | 2003-09-03 | CHIESI FARMACEUTICI S.p.A. | Aerosol formulations for pulmonary administration of medicaments having systemic effects |
| GB0520794D0 (en) * | 2005-10-12 | 2005-11-23 | Innovata Biomed Ltd | Inhaler |
-
2008
- 2008-07-17 UY UY31235A patent/UY31235A1/es not_active Application Discontinuation
- 2008-07-17 PE PE2008001219A patent/PE20090907A1/es not_active Application Discontinuation
- 2008-07-18 EP EP08786245.4A patent/EP2182933B1/de active Active
- 2008-07-18 TW TW097127515A patent/TW200909004A/zh unknown
- 2008-07-18 JP JP2010517374A patent/JP2011509919A/ja active Pending
- 2008-07-18 US US12/670,001 patent/US20100189780A1/en not_active Abandoned
- 2008-07-18 WO PCT/EP2008/059465 patent/WO2009013244A1/de not_active Ceased
- 2008-07-18 CA CA2694479A patent/CA2694479C/en not_active Expired - Fee Related
- 2008-07-21 AR ARP080103160A patent/AR067639A1/es unknown
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2004505685A (ja) * | 2000-08-04 | 2004-02-26 | ミクロドラッグ アーゲー | 電気的粉末 |
| JP2004018440A (ja) * | 2002-06-14 | 2004-01-22 | Ss Pharmaceut Co Ltd | 粉末状吸入剤組成物 |
| JP2006516135A (ja) * | 2002-12-20 | 2006-06-22 | ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト | チオトロピウム塩とキシナホ酸サルメテロールとを含む吸入用粉末医薬品 |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2015504911A (ja) * | 2012-01-26 | 2015-02-16 | マイクロ−マチナツィオネ ソシエテ アノニムＭｉｃｒｏ−Ｍａｃｉｎａｚｉｏｎｅ Ｓ．Ａ． | 高エネルギー流体ジェットミルを使用するメカノケミカル活性化法により調製された薬物／担体封入複合体 |
| JP2017530995A (ja) * | 2014-10-16 | 2017-10-19 | テバ ブランデッド ファーマシューティカル プロダクツ アール アンド ディー インコーポレイテッド | 乾燥粉末製剤 |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2694479C (en) | 2016-09-13 |
| US20100189780A1 (en) | 2010-07-29 |
| EP2182933B1 (de) | 2016-09-07 |
| CA2694479A1 (en) | 2009-01-29 |
| WO2009013244A1 (de) | 2009-01-29 |
| TW200909004A (en) | 2009-03-01 |
| AR067639A1 (es) | 2009-10-21 |
| EP2182933A1 (de) | 2010-05-12 |
| UY31235A1 (es) | 2009-03-02 |
| PE20090907A1 (es) | 2009-08-05 |
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