JPH10509738A - 乾燥粉末α1−アンチトリプシンの肺投与 - Google Patents
乾燥粉末α1−アンチトリプシンの肺投与Info
- Publication number
- JPH10509738A JPH10509738A JP8531208A JP53120896A JPH10509738A JP H10509738 A JPH10509738 A JP H10509738A JP 8531208 A JP8531208 A JP 8531208A JP 53120896 A JP53120896 A JP 53120896A JP H10509738 A JPH10509738 A JP H10509738A
- Authority
- JP
- Japan
- Prior art keywords
- dry powder
- antitrypsin
- α1at
- patient
- composition
- 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.)
- Ceased
Links
Classifications
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1658—Proteins, e.g. albumin, gelatin
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- 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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
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- 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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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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
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
- A61P5/12—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH for decreasing, blocking or antagonising the activity of the posterior pituitary hormones
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- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61M15/00—Inhalators
- A61M15/0086—Inhalation chambers
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/07—General characteristics of the apparatus having air pumping means
- A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
- A61M2205/073—Syringe, piston type
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Pulmonology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Otolaryngology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.α1−抗トリプシンを患者に投与するための方法であって、 前記α1−抗トリプシンを乾燥粉末として供給し; 前記乾燥粉末組成物をエアロゾル化し;そして 前記エアロゾル化された乾燥粉末組成物を前記患者の肺に投与することを含ん で成る方法。 2.エアロゾルを形成するためにガス流において一定量のα1−抗トリプシン 乾燥粉末を分散し;そして 患者による続く吸入のために適切なチャンバーに前記エアロゾルを捕獲するこ とを含んで成る請求の範囲第1項記載の方法。 3.前記供給段階において、前記α1−抗トリプシン乾燥粉末が約50%よりも 高い純度を有する請求の範囲第1項記載の方法。 4.前記供給段階において、前記α1−抗トリプシン乾燥粉末が約90%よりも 高い純度を有する請求の範囲第1項記載の方法。 5.前記供給段階において、前記α1−抗トリプシン乾燥粉末が約95%よりも 高い純度を有する請求の範囲第1項記載の方法。 6.前記供給段階において、前記α1−抗トリプシン乾燥粉末が約99%よりも 高い純度を有する請求の範囲第1項記載の方法。 7.前記供給段階において、前記α1−抗トリプシン乾燥粉末が微粒子の凝集 体を含んで成り、ここで前記微粒子が約1μm〜約5μmの平均粒子サイズを有 し、そして前記凝集体が約50μm〜約600 μmの平均サイズを有し、そして前記 凝集体が約10〜約60の脆砕指数を有する請求の範囲第1項記載の方法。 8.前記凝集体が球形状で存在する請求の範囲第7項記載の方法。 9.前記凝集体が非水性溶媒結合液体により形成される請求の範 囲第7項記載の方法。 10.前記非水性溶媒結合液体がフルオロカーボン液体を含んで成る請求の範囲 第9項記載の方法。 11.前記フルオロカーボン液体が、ペルフルオロデカリン及びペルフルオロオ クチルブロミドから成る群から選択される請求の範囲第10項記載の方法。 12.前記α1−抗トリプシンの分散性乾燥粉末組成物が約70%〜約90%の純度 を有する請求の範囲第7項記載の方法。 13.α1−抗トリプシンを欠損している患者の処理方法であって、治療的有効 量のα1−抗トリプシン乾燥粉末を、前記患者の肺に投与することを含んで成る 方法。 14.前記治療的有効量が1日当たりα1−抗トリプシン約1〜約50mgである請 求の範囲第13項記載の方法。 15.前記治療的有効量が1日当たりα1−抗トリプシン約5〜約25mgである請 求の範囲第13項記載の方法。 16.前記治療的有効量が1日当たりα1−抗トリプシン約10〜約15mgである請 求の範囲第13項記載の方法。 17.気腫を有する患者の処理方法であって、治療的有効量のエアロゾル化され た乾燥粉末α1−抗トリプシンを、前記患者の肺に投与することを含んで成る方 法。 18.α1−抗トリプシンを患者に投与するための装置であって、 一定量のα1−抗トリプシン乾燥粉末組成物を含むチャンバーをそこに配置し ているハウジング; 前記乾燥粉末組成物をエアロゾル化するために、前記チャンバーにガス流を供 給するための、前記チャンバーに流体的に連結されるガス加圧源;及び 前記患者による吸入のための前記エアロゾル化された乾燥粉末組 成物を供給するための、前記チャンバーに流体的に連結されている手段、を含ん で成る装置。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/423,515 US6582728B1 (en) | 1992-07-08 | 1995-04-14 | Spray drying of macromolecules to produce inhaleable dry powders |
US08/423,515 | 1995-04-14 | ||
US08/617,512 | 1996-03-13 | ||
US08/617,512 US5780014A (en) | 1995-04-14 | 1996-03-13 | Method and apparatus for pulmonary administration of dry powder alpha 1-antitrypsin |
PCT/US1996/005062 WO1996032152A1 (en) | 1995-04-14 | 1996-04-11 | Pulmonary administration of dry powder alpha 1-antitrypsin |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH10509738A true JPH10509738A (ja) | 1998-09-22 |
Family
ID=27026029
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP8531208A Ceased JPH10509738A (ja) | 1995-04-14 | 1996-04-11 | 乾燥粉末α1−アンチトリプシンの肺投与 |
Country Status (12)
Country | Link |
---|---|
US (2) | US5780014A (ja) |
EP (1) | EP0866726B2 (ja) |
JP (1) | JPH10509738A (ja) |
KR (1) | KR100430125B1 (ja) |
AT (1) | ATE260688T1 (ja) |
AU (1) | AU703491B2 (ja) |
BR (1) | BR9609497A (ja) |
CA (1) | CA2218208A1 (ja) |
DE (1) | DE69631786T3 (ja) |
ES (1) | ES2217309T5 (ja) |
MX (1) | MX9707854A (ja) |
WO (1) | WO1996032152A1 (ja) |
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-
1996
- 1996-03-13 US US08/617,512 patent/US5780014A/en not_active Expired - Lifetime
- 1996-04-11 BR BR9609497A patent/BR9609497A/pt not_active Application Discontinuation
- 1996-04-11 ES ES96911736T patent/ES2217309T5/es not_active Expired - Lifetime
- 1996-04-11 EP EP96911736A patent/EP0866726B2/en not_active Expired - Lifetime
- 1996-04-11 AU AU54825/96A patent/AU703491B2/en not_active Ceased
- 1996-04-11 JP JP8531208A patent/JPH10509738A/ja not_active Ceased
- 1996-04-11 AT AT96911736T patent/ATE260688T1/de not_active IP Right Cessation
- 1996-04-11 CA CA002218208A patent/CA2218208A1/en not_active Abandoned
- 1996-04-11 WO PCT/US1996/005062 patent/WO1996032152A1/en active IP Right Grant
- 1996-04-11 DE DE69631786T patent/DE69631786T3/de not_active Expired - Lifetime
- 1996-04-11 MX MX9707854A patent/MX9707854A/es not_active IP Right Cessation
- 1996-04-11 KR KR1019970707279A patent/KR100430125B1/ko not_active IP Right Cessation
-
1998
- 1998-07-13 US US09/114,713 patent/US5993783A/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
DE69631786T2 (de) | 2005-03-10 |
BR9609497A (pt) | 1999-03-02 |
DE69631786T3 (de) | 2008-07-24 |
MX9707854A (es) | 1998-02-28 |
AU5482596A (en) | 1996-10-30 |
WO1996032152A1 (en) | 1996-10-17 |
EP0866726A1 (en) | 1998-09-30 |
KR100430125B1 (ko) | 2004-08-18 |
ATE260688T1 (de) | 2004-03-15 |
ES2217309T3 (es) | 2004-11-01 |
CA2218208A1 (en) | 1996-10-17 |
AU703491B2 (en) | 1999-03-25 |
EP0866726B1 (en) | 2004-03-03 |
DE69631786D1 (de) | 2004-04-08 |
KR19980703879A (ko) | 1998-12-05 |
EP0866726B2 (en) | 2008-01-09 |
US5780014A (en) | 1998-07-14 |
US5993783A (en) | 1999-11-30 |
EP0866726A4 (ja) | 1998-09-30 |
ES2217309T5 (es) | 2008-06-01 |
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