AU2003221700A1 - Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b - Google Patents
Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b Download PDFInfo
- Publication number
- AU2003221700A1 AU2003221700A1 AU2003221700A AU2003221700A AU2003221700A1 AU 2003221700 A1 AU2003221700 A1 AU 2003221700A1 AU 2003221700 A AU2003221700 A AU 2003221700A AU 2003221700 A AU2003221700 A AU 2003221700A AU 2003221700 A1 AU2003221700 A1 AU 2003221700A1
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- Australia
- Prior art keywords
- formulation
- per
- interferon
- alpha
- alpha interferon
- 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.)
- Abandoned
Links
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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
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/212—IFN-alpha
-
- 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
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dispersion Chemistry (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/159,083 US6830744B2 (en) | 2002-05-31 | 2002-05-31 | Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b |
| US10/159,083 | 2002-05-31 | ||
| PCT/US2003/010832 WO2003102014A2 (en) | 2002-05-31 | 2003-04-08 | Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2003221700A1 true AU2003221700A1 (en) | 2003-12-19 |
Family
ID=29582814
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2003221700A Abandoned AU2003221700A1 (en) | 2002-05-31 | 2003-04-08 | Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US6830744B2 (https=) |
| EP (1) | EP1515744A4 (https=) |
| JP (1) | JP2005531604A (https=) |
| AU (1) | AU2003221700A1 (https=) |
| CA (1) | CA2484626A1 (https=) |
| WO (1) | WO2003102014A2 (https=) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10134650B4 (de) * | 2001-07-20 | 2009-12-03 | Roche Diagnostics Gmbh | System zur Entnahme kleiner Körperflüssigkeitsmengen |
| US20050232899A1 (en) * | 2002-05-31 | 2005-10-20 | Aradigm Corporation | Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b |
| ITMI20032067A1 (it) * | 2003-10-23 | 2005-04-24 | Unihart Corp | Formulazione spray per il trattamento delle infezioni virali. |
| CN101522244B (zh) * | 2006-08-01 | 2013-06-26 | 日本烟草产业株式会社 | 气雾吸引器 |
| CN103209728B (zh) * | 2010-09-24 | 2015-10-14 | 多诺万·B.·耶茨 | 紧凑、低流阻的气溶胶发生器及其操作方法 |
| CN105310988B (zh) * | 2015-11-23 | 2018-05-04 | 哈药集团生物工程有限公司 | 一种含有重组人干扰素α2b的冻干药物组合物 |
| CN113491807B (zh) * | 2020-04-03 | 2023-07-28 | 深圳麦克韦尔科技有限公司 | 一种气溶胶产生装置 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3262575D1 (en) | 1981-12-23 | 1985-04-18 | Schering Corp | Stabilised interferon formulations and their preparation |
| JPH05963A (ja) * | 1990-04-13 | 1993-01-08 | Toray Ind Inc | ポリペプチド類組成物 |
| US5743250A (en) | 1993-01-29 | 1998-04-28 | Aradigm Corporation | Insulin delivery enhanced by coached breathing |
| US5558085A (en) | 1993-01-29 | 1996-09-24 | Aradigm Corporation | Intrapulmonary delivery of peptide drugs |
| US5709202A (en) | 1993-05-21 | 1998-01-20 | Aradigm Corporation | Intrapulmonary delivery of aerosolized formulations |
| US5509404A (en) | 1994-07-11 | 1996-04-23 | Aradigm Corporation | Intrapulmonary drug delivery within therapeutically relevant inspiratory flow/volume values |
| US5522385A (en) | 1994-09-27 | 1996-06-04 | Aradigm Corporation | Dynamic particle size control for aerosolized drug delivery |
| US5766582A (en) | 1994-10-11 | 1998-06-16 | Schering Corporation | Stable, aqueous alfa interferon solution formulations |
| US5906202A (en) | 1996-11-21 | 1999-05-25 | Aradigm Corporation | Device and method for directing aerosolized mist to a specific area of the respiratory tract |
| US6131570A (en) | 1998-06-30 | 2000-10-17 | Aradigm Corporation | Temperature controlling device for aerosol drug delivery |
| KR100399156B1 (ko) * | 1999-11-19 | 2003-09-26 | 주식회사 엘지생명과학 | α-인터페론의 용액제형 |
| KR20020072563A (ko) | 1999-12-30 | 2002-09-16 | 인터뮨, 인크. | γ―ＩＦＮ 액체―소적 에어로졸 및 방법 |
| WO2001080897A2 (en) * | 2000-04-21 | 2001-11-01 | Vical Incorporated | Compositions and methods for in vivo delivery of polynucleotide-based therapeutics |
| IN191090B (https=) * | 2000-08-29 | 2003-09-20 | Ranbanx Lab Ltd | |
| AU2587002A (en) * | 2000-11-03 | 2002-05-15 | Biomedicines Inc | Method for short-term and long-term drug dosimetry |
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- 2003-04-08 JP JP2004509705A patent/JP2005531604A/ja active Pending
- 2003-04-08 WO PCT/US2003/010832 patent/WO2003102014A2/en not_active Ceased
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| EP1515744A4 (en) | 2008-04-16 |
| US20030223936A1 (en) | 2003-12-04 |
| CA2484626A1 (en) | 2003-12-11 |
| US6830744B2 (en) | 2004-12-14 |
| WO2003102014A3 (en) | 2004-09-30 |
| WO2003102014A2 (en) | 2003-12-11 |
| JP2005531604A (ja) | 2005-10-20 |
| EP1515744A2 (en) | 2005-03-23 |
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