JP5154732B2 - 薬剤 - Google Patents
薬剤 Download PDFInfo
- Publication number
- JP5154732B2 JP5154732B2 JP2002562324A JP2002562324A JP5154732B2 JP 5154732 B2 JP5154732 B2 JP 5154732B2 JP 2002562324 A JP2002562324 A JP 2002562324A JP 2002562324 A JP2002562324 A JP 2002562324A JP 5154732 B2 JP5154732 B2 JP 5154732B2
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- bimodal
- composition according
- active ingredient
- fraction
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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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
- A61K9/0012—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
-
- 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
- A61K31/16—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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Pain & Pain Management (AREA)
- Otolaryngology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Description
フランス国特許番号第2584604号には、微細な粉末(<100μm)と粗い結晶(500−700μm)とを含む経口、経腸、投与のための新規な医薬投与形態が記載されている。しかし、このような組成物は、例えば吸入による投与には好適ではない。
国際特許出願番号WO98/31352には、例えば、微粉化したフマル酸フォルモテロール無水物(MMD<3μm)と、微粉化したブデソニド(粒子サイズ<3μm)の混合物を含む吸入療法を記載している。
[製剤]
粗大フラクションとして、6μgの粒径が5〜6μmのフマル酸ホルモテロールと、微細フラクションとして、100μgの粒径2〜3μmのプロピオン酸フルチカゾンとを含むバイモーダル乾燥粉末吸入製剤を製造した。
Claims (16)
- 第一の活性成分を含む空気力学的粒径が4〜12μmである粗大フラクションと、第二の活性成分を含む空気力学的粒径が1〜4μmである微細フラクションとの有効量を含むバイモーダル医薬組成物であって、該粗大フラクションは、該微細フラクションより大きいマスメジアン空気動力学的粒径(MMAD)を有し、該第一の活性成分が、患者の中央気道/上部気道で活性な気管支拡張薬であり、該第二の活性成分が、抗炎症剤であるバイモーダル医薬組成物。
- 前記粗大フラクションの少なくとも50%w/wは、4〜12μmの空気力学的粒径を有することを特徴とする、請求項1に記載のバイモーダル医薬組成物。
- 前記微細フラクションの少なくとも50%w/wは、1〜4μmの空気力学的粒径を有することを特徴とする、請求項1に記載のバイモーダル医薬組成物。
- 前記組成物は、フレーバー剤を含むことを特徴とする、請求項1に記載のバイモーダル組成物。
- 前記フレーバー剤は、前記粗大フラクションに含まれることを特徴とする、請求項4に記載のバイモーダル組成物。
- 前記フレーバー剤は、第一の活性成分より大きい空気力学的粒径を有することを特徴とする、請求項5に記載のバイモーダル組成物。
- 前記第二の活性成分は、肺末梢で活性であることを特徴とする、請求項1に記載のバイモーダル医薬組成物。
- 前記抗炎症剤はコルチコステロイドであることを特徴とする、請求項1に記載のバイモーダル医薬組成物。
- 前記組成物は、吸収促進剤を含むことを特徴とする、請求項1に記載のバイモーダル医薬組成物。
- 少なくとも1つの好適な噴射剤と混合された医薬組成物を含む、加圧エアロゾールにより投与するのに好適な、請求項1に記載のバイモーダル医薬組成物。
- ドライパウダー式吸入器により投与するのに好適な、請求項1に記載のバイモーダル医薬組成物。
- 請求項1に記載の医薬組成物を含有するドライパウダー式吸入器。
- 患者に投与可能な一回の投薬量として、3〜200μgの前記第一の活性成分と、20〜1000μgの前記第二の活性成分とを含むことを特徴とする、請求項1に記載のバイモーダル医薬組成物。
- ネブライザーにより投与するのに好適な懸濁液である、請求項1に記載のバイモーダル医薬組成物。
- 投薬量が、1μg〜500mgの範囲であることを特徴とする、請求項14に記載のバイモーダル医薬組成物。
- 請求項1に記載のバイモーダル医薬組成物の製造方法であって、前記粗大フラクションと前記微細フラクションとを混合するステップと、任意選択的に、製薬学的に許容可能なアジュバント、希釈剤又はキャリアを同時に又は連続して混合するステップとを含む方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0102902.4 | 2001-02-06 | ||
GBGB0102902.4A GB0102902D0 (en) | 2001-02-06 | 2001-02-06 | Medicaments |
GB0109215A GB0109215D0 (en) | 2001-04-12 | 2001-04-12 | Medicaments |
GB0109215.4 | 2001-04-12 | ||
PCT/GB2002/000480 WO2002062317A2 (en) | 2001-02-06 | 2002-02-05 | Bimodal dry powder formulation for inhalation |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2004523536A JP2004523536A (ja) | 2004-08-05 |
JP2004523536A5 JP2004523536A5 (ja) | 2005-12-22 |
JP5154732B2 true JP5154732B2 (ja) | 2013-02-27 |
Family
ID=26245685
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2002562324A Expired - Fee Related JP5154732B2 (ja) | 2001-02-06 | 2002-02-05 | 薬剤 |
Country Status (12)
Country | Link |
---|---|
US (3) | US20060292085A1 (ja) |
EP (1) | EP1359902B1 (ja) |
JP (1) | JP5154732B2 (ja) |
AT (1) | ATE369121T1 (ja) |
BR (1) | BR0207062A (ja) |
CA (1) | CA2435982C (ja) |
DE (1) | DE60221640T2 (ja) |
ES (1) | ES2291452T3 (ja) |
MX (1) | MXPA03007017A (ja) |
NO (1) | NO20033451L (ja) |
PL (1) | PL365736A1 (ja) |
WO (1) | WO2002062317A2 (ja) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6962151B1 (en) * | 1999-11-05 | 2005-11-08 | Pari GmbH Spezialisten für effektive Inhalation | Inhalation nebulizer |
US20030055026A1 (en) | 2001-04-17 | 2003-03-20 | Dey L.P. | Formoterol/steroid bronchodilating compositions and methods of use thereof |
PT1572217E (pt) * | 2002-12-12 | 2008-11-28 | Nycomed Gmbh | Medicamento combinado de r,r-formoterol e ciclesonida |
WO2014165303A1 (en) | 2013-04-01 | 2014-10-09 | Pulmatrix, Inc. | Tiotropium dry powders |
MX2017005692A (es) | 2014-10-31 | 2017-08-07 | Glaxosmithkline Ip Dev Ltd | Formulacion en polvo. |
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GB0102902D0 (en) * | 2001-02-06 | 2001-03-21 | Innovata Biomed Ltd | Medicaments |
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GB0128148D0 (en) * | 2001-11-23 | 2002-01-16 | Innovata Biomed Ltd | Assembly |
US20040101782A1 (en) * | 2002-11-27 | 2004-05-27 | General Electric Company | Method for making optical device structures |
-
2002
- 2002-02-05 PL PL02365736A patent/PL365736A1/xx unknown
- 2002-02-05 ES ES02712031T patent/ES2291452T3/es not_active Expired - Lifetime
- 2002-02-05 MX MXPA03007017A patent/MXPA03007017A/es unknown
- 2002-02-05 AT AT02712031T patent/ATE369121T1/de active
- 2002-02-05 JP JP2002562324A patent/JP5154732B2/ja not_active Expired - Fee Related
- 2002-02-05 DE DE60221640T patent/DE60221640T2/de not_active Expired - Lifetime
- 2002-02-05 CA CA2435982A patent/CA2435982C/en not_active Expired - Fee Related
- 2002-02-05 BR BR0207062-6A patent/BR0207062A/pt not_active Application Discontinuation
- 2002-02-05 WO PCT/GB2002/000480 patent/WO2002062317A2/en active IP Right Grant
- 2002-02-05 EP EP02712031A patent/EP1359902B1/en not_active Revoked
-
2003
- 2003-08-04 NO NO20033451A patent/NO20033451L/no not_active Application Discontinuation
-
2006
- 2006-08-29 US US11/511,730 patent/US20060292085A1/en not_active Abandoned
-
2010
- 2010-01-07 US US12/683,959 patent/US20100136121A1/en not_active Abandoned
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2014
- 2014-07-31 US US14/448,493 patent/US20140342001A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
ES2291452T3 (es) | 2008-03-01 |
EP1359902B1 (en) | 2007-08-08 |
US20140342001A1 (en) | 2014-11-20 |
JP2004523536A (ja) | 2004-08-05 |
EP1359902A2 (en) | 2003-11-12 |
DE60221640D1 (de) | 2007-09-20 |
WO2002062317A2 (en) | 2002-08-15 |
US20060292085A1 (en) | 2006-12-28 |
NO20033451L (no) | 2003-10-03 |
CA2435982A1 (en) | 2002-08-15 |
ATE369121T1 (de) | 2007-08-15 |
BR0207062A (pt) | 2004-10-05 |
CA2435982C (en) | 2014-05-06 |
WO2002062317A3 (en) | 2002-11-21 |
DE60221640T2 (de) | 2008-05-21 |
PL365736A1 (en) | 2005-01-10 |
US20100136121A1 (en) | 2010-06-03 |
MXPA03007017A (es) | 2004-09-13 |
NO20033451D0 (no) | 2003-08-04 |
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