AU2005307825C1 - Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions - Google Patents

Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions Download PDF

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Publication number
AU2005307825C1
AU2005307825C1 AU2005307825A AU2005307825A AU2005307825C1 AU 2005307825 C1 AU2005307825 C1 AU 2005307825C1 AU 2005307825 A AU2005307825 A AU 2005307825A AU 2005307825 A AU2005307825 A AU 2005307825A AU 2005307825 C1 AU2005307825 C1 AU 2005307825C1
Authority
AU
Australia
Prior art keywords
suspension
glucocorticosteroid
sterile
vessel
heating
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
Application number
AU2005307825A
Other languages
English (en)
Other versions
AU2005307825A1 (en
AU2005307825B2 (en
Inventor
Adrian Ashley
Paul Lamb
Donald Mcdonald
John Miller
Martin Oliver
Matthew Pollard
Paul Ronald
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Norton Healthcare Ltd
Original Assignee
Norton Healthcare Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Norton Healthcare Ltd filed Critical Norton Healthcare Ltd
Publication of AU2005307825A1 publication Critical patent/AU2005307825A1/en
Application granted granted Critical
Publication of AU2005307825B2 publication Critical patent/AU2005307825B2/en
Priority to AU2012200155A priority Critical patent/AU2012200155B2/en
Publication of AU2005307825C1 publication Critical patent/AU2005307825C1/en
Anticipated expiration legal-status Critical
Expired legal-status Critical Current

Links

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
    • 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

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)
AU2005307825A 2004-11-16 2005-11-16 Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions Expired AU2005307825C1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2012200155A AU2012200155B2 (en) 2004-11-16 2012-01-11 Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions

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
AU2012200155A Division AU2012200155B2 (en) 2004-11-16 2012-01-11 Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions

Publications (3)

Publication Number Publication Date
AU2005307825A1 AU2005307825A1 (en) 2006-05-26
AU2005307825B2 AU2005307825B2 (en) 2011-10-13
AU2005307825C1 true AU2005307825C1 (en) 2012-08-09

Family

ID=33523819

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2005307825A Expired AU2005307825C1 (en) 2004-11-16 2005-11-16 Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions

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)

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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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002078102A2 (en) * 2001-03-21 2002-10-03 Hewlett-Packard Company Fabricating a molecular electronic device having a protective barrier layer
WO2005115332A2 (en) * 2004-05-17 2005-12-08 Norton Healthcare, Ltd. Heat sterilization of glucocorticosteroids

Family Cites Families (18)

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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
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002078102A2 (en) * 2001-03-21 2002-10-03 Hewlett-Packard Company Fabricating a molecular electronic device having a protective barrier layer
WO2005115332A2 (en) * 2004-05-17 2005-12-08 Norton Healthcare, Ltd. Heat sterilization of glucocorticosteroids

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
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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Legal Events

Date Code Title Description
DA2 Applications for amendment section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 11 JAN 2012.

DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 11 JAN 2012

FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired