CN101068531B - 热灭菌的糖皮质激素悬浮液的药物生产方法 - Google Patents

热灭菌的糖皮质激素悬浮液的药物生产方法 Download PDF

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Publication number
CN101068531B
CN101068531B CN2005800415649A CN200580041564A CN101068531B CN 101068531 B CN101068531 B CN 101068531B CN 2005800415649 A CN2005800415649 A CN 2005800415649A CN 200580041564 A CN200580041564 A CN 200580041564A CN 101068531 B CN101068531 B CN 101068531B
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China
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glucocorticoid
suspension
sterile
container
heating
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Expired - Lifetime
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CN2005800415649A
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English (en)
Chinese (zh)
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CN101068531A (zh
Inventor
J·米勒
P·罗纳尔德
A·阿什利
P·兰姆
D·麦克唐纳
M·奥利弗
M·波拉德
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Norton Hillskel GmbH
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Norton Hillskel GmbH
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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
    • 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
    • A61K31/57—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
    • 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
    • A61K31/57—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
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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

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  • 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)
CN2005800415649A 2004-11-16 2005-11-16 热灭菌的糖皮质激素悬浮液的药物生产方法 Expired - Lifetime CN101068531B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0425266.4 2004-11-16
GB0425266A GB0425266D0 (en) 2004-11-16 2004-11-16 Pharmaceutical manufacturing process
PCT/US2005/041524 WO2006055632A2 (en) 2004-11-16 2005-11-16 Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN2011102299122A Division CN102327211A (zh) 2004-11-16 2005-11-16 热灭菌的糖皮质激素悬浮液的药物生产方法

Publications (2)

Publication Number Publication Date
CN101068531A CN101068531A (zh) 2007-11-07
CN101068531B true CN101068531B (zh) 2011-10-05

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CN2005800415649A Expired - Lifetime CN101068531B (zh) 2004-11-16 2005-11-16 热灭菌的糖皮质激素悬浮液的药物生产方法
CN2011102299122A Pending CN102327211A (zh) 2004-11-16 2005-11-16 热灭菌的糖皮质激素悬浮液的药物生产方法

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CN2011102299122A Pending CN102327211A (zh) 2004-11-16 2005-11-16 热灭菌的糖皮质激素悬浮液的药物生产方法

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=)

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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

Citations (6)

* Cited by examiner, † Cited by third party
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
WO2000025746A2 (en) * 1998-11-03 2000-05-11 Chiesi Farmaceutici S.P.A. A process for the preparation of suspensions of drug particles for inhalation delivery
WO2002041925A1 (en) * 2000-11-24 2002-05-30 Breath Limited Sterilisation of pharmaceuticals
DE10145361A1 (de) * 2001-09-14 2003-04-03 Pari Gmbh Verfahren zur Herstellung von flüssigen, sterilen Zubereitungen zur Inhalation
WO2004078102A2 (en) * 2003-03-04 2004-09-16 Dompe S.P.A. Sterilization of beclomethasone drug particles for pulmonary delivery
WO2004082659A1 (en) * 2003-03-17 2004-09-30 Baxter International Inc. Method for preparing small particles

Family Cites Families (14)

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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
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
US6541309B2 (en) * 2001-03-21 2003-04-01 Hewlett-Packard Development Company Lp Fabricating a molecular electronic device having a protective barrier layer
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
GB0410995D0 (en) * 2004-05-17 2004-06-23 Norton Healthcare Ltd Heat sterilization of glucocorticosteroids

Patent Citations (6)

* Cited by examiner, † Cited by third party
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
WO2000025746A2 (en) * 1998-11-03 2000-05-11 Chiesi Farmaceutici S.P.A. A process for the preparation of suspensions of drug particles for inhalation delivery
WO2002041925A1 (en) * 2000-11-24 2002-05-30 Breath Limited Sterilisation of pharmaceuticals
DE10145361A1 (de) * 2001-09-14 2003-04-03 Pari Gmbh Verfahren zur Herstellung von flüssigen, sterilen Zubereitungen zur Inhalation
WO2004078102A2 (en) * 2003-03-04 2004-09-16 Dompe S.P.A. Sterilization of beclomethasone drug particles for pulmonary delivery
WO2004082659A1 (en) * 2003-03-17 2004-09-30 Baxter International Inc. Method for preparing small particles

Also Published As

Publication number Publication date
WO2006055632A3 (en) 2007-05-24
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
PT1833462E (pt) 2013-05-22
AU2005307825B2 (en) 2011-10-13
US20120258939A1 (en) 2012-10-11
SI1833462T1 (sl) 2013-07-31
EP1833462A2 (en) 2007-09-19

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Granted publication date: 20111005