PT1833462E - Processo de fabrico farmacêutico para suspensões de glicocorticóides esterilizadas termicamente - Google Patents
Processo de fabrico farmacêutico para suspensões de glicocorticóides esterilizadas termicamente Download PDFInfo
- Publication number
- PT1833462E PT1833462E PT58517152T PT05851715T PT1833462E PT 1833462 E PT1833462 E PT 1833462E PT 58517152 T PT58517152 T PT 58517152T PT 05851715 T PT05851715 T PT 05851715T PT 1833462 E PT1833462 E PT 1833462E
- Authority
- PT
- Portugal
- Prior art keywords
- glucocorticosteroid
- suspension
- sterile
- vessel
- homogenizer
- Prior art date
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Classifications
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- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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- A—HUMAN NECESSITIES
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- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
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- 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
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- A61P37/08—Antiallergic agents
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Dispersion Chemistry (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0425266A GB0425266D0 (en) | 2004-11-16 | 2004-11-16 | Pharmaceutical manufacturing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PT1833462E true PT1833462E (pt) | 2013-05-22 |
Family
ID=33523819
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PT58517152T PT1833462E (pt) | 2004-11-16 | 2005-11-16 | Processo de fabrico farmacêutico para suspensões de glicocorticóides esterilizadas termicamente |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US8178519B2 (https=) |
| EP (1) | EP1833462B1 (https=) |
| JP (1) | JP5116478B2 (https=) |
| KR (1) | KR101226856B1 (https=) |
| CN (2) | CN101068531B (https=) |
| AU (1) | AU2005307825C1 (https=) |
| CA (1) | CA2587393C (https=) |
| CY (1) | CY1114150T1 (https=) |
| DK (1) | DK1833462T3 (https=) |
| ES (1) | ES2409713T3 (https=) |
| GB (1) | GB0425266D0 (https=) |
| IL (2) | IL183082A (https=) |
| PL (1) | PL1833462T3 (https=) |
| PT (1) | PT1833462E (https=) |
| SI (1) | SI1833462T1 (https=) |
| WO (1) | WO2006055632A2 (https=) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20050941A1 (es) | 2003-12-16 | 2005-11-08 | Nycomed Gmbh | Suspensiones acuosas de ciclesonida para nebulizacion |
| US10987361B2 (en) | 2010-02-08 | 2021-04-27 | Shenzhen Evergreen Therapeutics Co., Ltd. | Treating auto-immune and auto-inflammatory diseases |
| US10993879B2 (en) * | 2010-02-08 | 2021-05-04 | Shenzhen Evergreen Therapeutics Co., Ltd. | Pulmonary delivery of progestogen |
| EP3689364A1 (en) | 2010-02-08 | 2020-08-05 | Shenzhen Evergreen Therapeutics Co., Ltd. | Methods for the use of progestogen as a glucocorticoid sensitizer |
| WO2011139479A2 (en) | 2010-04-30 | 2011-11-10 | H R D Corporation | High shear application in drug delivery |
| US8888736B2 (en) | 2010-04-30 | 2014-11-18 | H R D Corporation | High shear application in medical therapy |
| IN2014CH01890A (https=) * | 2014-04-10 | 2015-10-16 | Aurobindo Pharma Ltd | |
| JP6521351B2 (ja) * | 2014-10-14 | 2019-05-29 | テックプロジェクトサービス株式会社 | ウィルス不活化およびサンプリング装置 |
| JP6719459B2 (ja) | 2014-10-29 | 2020-07-08 | アール.ピー.シェーラー テクノロジーズ、エルエルシー | 逆成形同時充填パッケージング |
| CN104739811A (zh) * | 2015-02-27 | 2015-07-01 | 上海臣邦医药科技有限公司 | 一种糖皮质激素雾化吸入混悬液及其制备方法 |
| EP3386483A4 (en) * | 2015-12-07 | 2019-06-05 | Emcure Pharmaceuticals Limited | STERILE PARENTERAL SUSPENSIONS |
| CN106904723A (zh) * | 2017-02-24 | 2017-06-30 | 东华大学 | 利用过氧化钙氧化去除水中糖皮质激素的方法 |
| WO2021230342A1 (ja) * | 2020-05-15 | 2021-11-18 | 大日本印刷株式会社 | 無菌充填機の洗浄・殺菌方法及び無菌充填機 |
| WO2022098321A1 (en) * | 2020-11-09 | 2022-05-12 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Process for the preparation of sterilised suspensions for the administration by inhalation |
| CN112891328A (zh) * | 2021-04-12 | 2021-06-04 | 上海方予健康医药科技有限公司 | 一种吸入用布地奈德混悬液的制备方法 |
| WO2022231533A1 (en) * | 2021-04-29 | 2022-11-03 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Process for the preparation of sterilized suspensions for the inhalation by nebulization |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3962430A (en) * | 1974-08-07 | 1976-06-08 | Merck & Co., Inc. | Sterilization of solid non-electrolyte medicinal agents employing sodium chloride |
| DE4026978A1 (de) * | 1990-08-25 | 1992-02-27 | Bayer Ag | Auf traegern angebrachte ein- oder mehrlagige schichtelemente und ihre herstellung |
| GB9410222D0 (en) | 1994-05-21 | 1994-07-06 | Glaxo Wellcome Australia Ltd | Medicaments |
| SE9704186D0 (sv) | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
| US6066292A (en) * | 1997-12-19 | 2000-05-23 | Bayer Corporation | Sterilization process for pharmaceutical suspensions |
| EP0938896A1 (en) | 1998-01-15 | 1999-09-01 | Novartis AG | Autoclavable pharmaceutical compositions containing a chelating agent |
| IT1303692B1 (it) * | 1998-11-03 | 2001-02-23 | Chiesi Farma Spa | Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione. |
| EP1074369B1 (fr) * | 1999-08-04 | 2005-10-05 | Conception et Développement Michelin S.A. | Procédé de fabrication de pièces en composite fortement sollicitées |
| JP4516165B2 (ja) * | 1999-08-04 | 2010-08-04 | 株式会社ユポ・コーポレーション | 多層樹脂延伸フィルム |
| KR100657729B1 (ko) * | 1999-10-21 | 2006-12-13 | 신닛테츠가가쿠 가부시키가이샤 | 적층체 및 그의 제조방법 |
| JP3862924B2 (ja) * | 2000-03-27 | 2006-12-27 | 日東電工株式会社 | 光学フィルム積層体 |
| DE60132446T2 (de) * | 2000-03-28 | 2009-01-15 | The Board Of Regents Of Oklahoma State University, Stillwater | Anordnung selbsttragender filme mittels eines schichtweisen verfahrens |
| DE60143892D1 (de) * | 2000-07-21 | 2011-03-03 | Cellseed Ind | Herzmuskel-ähnliche zellschicht, dreidimensionales konstrukt, herzmuskel-ähnliches gewebe und verfahren zur herstellung |
| BR0115584A (pt) * | 2000-11-24 | 2003-09-23 | Breath Ltd | Esterilização de produtos farmacêuticos |
| US20040022862A1 (en) * | 2000-12-22 | 2004-02-05 | Kipp James E. | Method for preparing small particles |
| US6541309B2 (en) * | 2001-03-21 | 2003-04-01 | Hewlett-Packard Development Company Lp | Fabricating a molecular electronic device having a protective barrier layer |
| DE10145361A1 (de) * | 2001-09-14 | 2003-04-03 | Pari Gmbh | Verfahren zur Herstellung von flüssigen, sterilen Zubereitungen zur Inhalation |
| ITMI20020808A1 (it) | 2002-04-17 | 2003-10-17 | Chiesi Farma Spa | Procedimento per la preparazione di una sospensione sterile di particelle di beclometasone dipropionato da somministrare per inalazione |
| EP1454636A1 (en) * | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Sterilization of glucocorticoid drug particles for pulmonary delivery |
| GB0410995D0 (en) * | 2004-05-17 | 2004-06-23 | Norton Healthcare Ltd | Heat sterilization of glucocorticosteroids |
-
2004
- 2004-11-16 GB GB0425266A patent/GB0425266D0/en not_active Ceased
-
2005
- 2005-11-16 CN CN2005800415649A patent/CN101068531B/zh not_active Expired - Lifetime
- 2005-11-16 AU AU2005307825A patent/AU2005307825C1/en not_active Expired
- 2005-11-16 US US11/667,872 patent/US8178519B2/en active Active
- 2005-11-16 CA CA2587393A patent/CA2587393C/en not_active Expired - Lifetime
- 2005-11-16 DK DK05851715.2T patent/DK1833462T3/da active
- 2005-11-16 ES ES05851715T patent/ES2409713T3/es not_active Expired - Lifetime
- 2005-11-16 SI SI200531722T patent/SI1833462T1/sl unknown
- 2005-11-16 EP EP05851715.2A patent/EP1833462B1/en not_active Expired - Lifetime
- 2005-11-16 PT PT58517152T patent/PT1833462E/pt unknown
- 2005-11-16 CN CN2011102299122A patent/CN102327211A/zh active Pending
- 2005-11-16 JP JP2007541462A patent/JP5116478B2/ja not_active Expired - Lifetime
- 2005-11-16 WO PCT/US2005/041524 patent/WO2006055632A2/en not_active Ceased
- 2005-11-16 KR KR1020077011131A patent/KR101226856B1/ko not_active Expired - Lifetime
- 2005-11-16 PL PL05851715T patent/PL1833462T3/pl unknown
-
2007
- 2007-05-09 IL IL183082A patent/IL183082A/en active IP Right Grant
-
2012
- 2012-04-16 US US13/447,468 patent/US20120258939A1/en not_active Abandoned
-
2013
- 2013-05-16 CY CY20131100393T patent/CY1114150T1/el unknown
- 2013-10-03 IL IL228730A patent/IL228730A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| WO2006055632A3 (en) | 2007-05-24 |
| CN101068531B (zh) | 2011-10-05 |
| KR101226856B1 (ko) | 2013-01-25 |
| IL228730A (en) | 2016-12-29 |
| JP5116478B2 (ja) | 2013-01-09 |
| CY1114150T1 (el) | 2016-07-27 |
| US8178519B2 (en) | 2012-05-15 |
| DK1833462T3 (da) | 2013-05-21 |
| KR20070089675A (ko) | 2007-08-31 |
| CA2587393C (en) | 2010-09-28 |
| EP1833462B1 (en) | 2013-04-17 |
| JP2008531467A (ja) | 2008-08-14 |
| US20080269178A1 (en) | 2008-10-30 |
| CN102327211A (zh) | 2012-01-25 |
| AU2005307825C1 (en) | 2012-08-09 |
| PL1833462T3 (pl) | 2013-10-31 |
| AU2005307825A1 (en) | 2006-05-26 |
| IL183082A (en) | 2014-09-30 |
| CA2587393A1 (en) | 2006-05-26 |
| IL228730A0 (en) | 2013-12-31 |
| CN101068531A (zh) | 2007-11-07 |
| GB0425266D0 (en) | 2004-12-15 |
| ES2409713T3 (es) | 2013-06-27 |
| IL183082A0 (en) | 2008-03-20 |
| WO2006055632A2 (en) | 2006-05-26 |
| AU2005307825B2 (en) | 2011-10-13 |
| US20120258939A1 (en) | 2012-10-11 |
| SI1833462T1 (sl) | 2013-07-31 |
| EP1833462A2 (en) | 2007-09-19 |
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