CN1988886B - 糖皮质激素的热力灭菌法 - Google Patents

糖皮质激素的热力灭菌法 Download PDF

Info

Publication number
CN1988886B
CN1988886B CN2005800159892A CN200580015989A CN1988886B CN 1988886 B CN1988886 B CN 1988886B CN 2005800159892 A CN2005800159892 A CN 2005800159892A CN 200580015989 A CN200580015989 A CN 200580015989A CN 1988886 B CN1988886 B CN 1988886B
Authority
CN
China
Prior art keywords
glucocorticoid
budesonide
suspension
heating
sterilization
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 - Lifetime
Application number
CN2005800159892A
Other languages
English (en)
Chinese (zh)
Other versions
CN1988886A (zh
Inventor
A·阿施勒
P·兰姆
D·麦克唐纳
J·米勒
M·J·奥利弗
M·泊拉德
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 Hillskel GmbH
Original Assignee
Norton Hillskel GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32607464&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN1988886(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Norton Hillskel GmbH filed Critical Norton Hillskel GmbH
Priority to CN201210068425.7A priority Critical patent/CN102600491B/zh
Publication of CN1988886A publication Critical patent/CN1988886A/zh
Application granted granted Critical
Publication of CN1988886B publication Critical patent/CN1988886B/zh
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Images

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
    • A61K9/14—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
    • 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
    • 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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/04—Heat
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J5/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Immunology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Steroid Compounds (AREA)
  • Dairy Products (AREA)
CN2005800159892A 2004-05-17 2005-05-17 糖皮质激素的热力灭菌法 Expired - Lifetime CN1988886B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201210068425.7A CN102600491B (zh) 2004-05-17 2005-05-17 糖皮质激素的热力灭菌法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0410995.5 2004-05-17
GBGB0410995.5A GB0410995D0 (en) 2004-05-17 2004-05-17 Heat sterilization of glucocorticosteroids
PCT/US2005/017292 WO2005115332A2 (en) 2004-05-17 2005-05-17 Heat sterilization of glucocorticosteroids

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201210068425.7A Division CN102600491B (zh) 2004-05-17 2005-05-17 糖皮质激素的热力灭菌法

Publications (2)

Publication Number Publication Date
CN1988886A CN1988886A (zh) 2007-06-27
CN1988886B true CN1988886B (zh) 2012-11-07

Family

ID=32607464

Family Applications (2)

Application Number Title Priority Date Filing Date
CN2005800159892A Expired - Lifetime CN1988886B (zh) 2004-05-17 2005-05-17 糖皮质激素的热力灭菌法
CN201210068425.7A Expired - Lifetime CN102600491B (zh) 2004-05-17 2005-05-17 糖皮质激素的热力灭菌法

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201210068425.7A Expired - Lifetime CN102600491B (zh) 2004-05-17 2005-05-17 糖皮质激素的热力灭菌法

Country Status (21)

Country Link
US (2) US8791096B2 (https=)
EP (3) EP3299013A1 (https=)
JP (2) JP5116469B2 (https=)
KR (1) KR101148446B1 (https=)
CN (2) CN1988886B (https=)
AU (1) AU2005247422B8 (https=)
CA (1) CA2569549C (https=)
CY (1) CY1115948T1 (https=)
DK (2) DK2805712T4 (https=)
ES (2) ES2525877T3 (https=)
FI (1) FI2805712T4 (https=)
GB (1) GB0410995D0 (https=)
HK (1) HK1252557A1 (https=)
HU (1) HUE037567T2 (https=)
IL (1) IL179066A (https=)
LT (1) LT2805712T (https=)
MX (1) MXPA06012874A (https=)
PL (2) PL2805712T5 (https=)
PT (2) PT1755554E (https=)
SI (2) SI1755554T1 (https=)
WO (1) WO2005115332A2 (https=)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20050941A1 (es) 2003-12-16 2005-11-08 Nycomed Gmbh Suspensiones acuosas de ciclesonida para nebulizacion
GB0425266D0 (en) * 2004-11-16 2004-12-15 Norton Healthcare Ltd Pharmaceutical manufacturing process
EP2704724B1 (en) * 2011-05-03 2016-10-26 Chiesi Farmaceutici S.p.A. Improved suspension formulation of beclometasone dipropionate for administration by inhalation
CN104052572B (zh) * 2013-03-11 2019-07-02 北京三星通信技术研究有限公司 一种下行传输方法和用户终端设备
US9867973B2 (en) 2013-06-17 2018-01-16 Medline Industries, Inc. Skin antiseptic applicator and methods of making and using the same
US9511156B2 (en) 2014-01-08 2016-12-06 Carefusion 2200, Inc. Systems, methods, and devices for sterilizing antiseptic solutions
US11027032B2 (en) * 2014-01-08 2021-06-08 Carefusion 2200, Inc. Systems, methods, and devices for sterilizing antiseptic solutions
AU2016288582B2 (en) * 2015-06-30 2020-05-21 Carefusion 2200, Inc. Systems, methods, and devices for sterilizing antiseptic solutions
US9895455B2 (en) 2015-06-30 2018-02-20 Carefusion 2200, Inc Systems, methods, and devices for sterilizing antiseptic solutions
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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5993781A (en) * 1994-05-21 1999-11-30 Glaxo Wellcome Australia Ltd. Fluticasone propionate nebulizable formulations
CN1282256A (zh) * 1997-12-19 2001-01-31 拜尔公司 药物悬浮液的新型灭菌法
CN1335766A (zh) * 1998-11-03 2002-02-13 奇斯药制品公司 一种制备用于吸入给药的药物颗粒悬浮体的方法
US20020065256A1 (en) * 1997-11-14 2002-05-30 Ann-Kristin Karlsson New composition of matter

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3692430A (en) 1971-06-18 1972-09-19 John W Timmons Liquid pumping system
US3962430A (en) 1974-08-07 1976-06-08 Merck & Co., Inc. Sterilization of solid non-electrolyte medicinal agents employing sodium chloride
US5933781A (en) 1997-01-31 1999-08-03 Qualcomm Incorporated Pilot based, reversed channel power control
US6598603B1 (en) * 1997-12-31 2003-07-29 Astra Aktiebolag Method for treating respiratory diseases
EP0938896A1 (en) 1998-01-15 1999-09-01 Novartis AG Autoclavable pharmaceutical compositions containing a chelating agent
US6241969B1 (en) * 1998-06-26 2001-06-05 Elan Corporation Plc Aqueous compositions containing corticosteroids for nasal and pulmonary delivery
US6267989B1 (en) 1999-03-08 2001-07-31 Klan Pharma International Ltd. Methods for preventing crystal growth and particle aggregation in nanoparticulate compositions
BR0115584A (pt) * 2000-11-24 2003-09-23 Breath Ltd Esterilização de produtos farmacêuticos
NL1016981C2 (nl) 2000-12-22 2002-06-25 Nutricia Nv Pasteuriseren of steriliseren.
DE10145361A1 (de) † 2001-09-14 2003-04-03 Pari Gmbh Verfahren zur Herstellung von flüssigen, sterilen Zubereitungen zur Inhalation
US7112340B2 (en) * 2001-10-19 2006-09-26 Baxter International Inc. Compositions of and method for preparing stable particles in a frozen aqueous matrix
BRPI0312377A8 (pt) 2002-07-02 2015-12-15 Altana Pharma Ag Suspensão aquosa estéril contendo ciclesonida
EP1454636A1 (en) * 2003-03-04 2004-09-08 Dompé S.P.A. Sterilization of glucocorticoid drug particles for pulmonary delivery
US7892483B2 (en) 2004-03-12 2011-02-22 Cipla Limited Sterilization process

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5993781A (en) * 1994-05-21 1999-11-30 Glaxo Wellcome Australia Ltd. Fluticasone propionate nebulizable formulations
US20020065256A1 (en) * 1997-11-14 2002-05-30 Ann-Kristin Karlsson New composition of matter
CN1282256A (zh) * 1997-12-19 2001-01-31 拜尔公司 药物悬浮液的新型灭菌法
CN1335766A (zh) * 1998-11-03 2002-02-13 奇斯药制品公司 一种制备用于吸入给药的药物颗粒悬浮体的方法

Also Published As

Publication number Publication date
ES2670706T3 (es) 2018-05-31
PL2805712T5 (pl) 2023-02-27
PT1755554E (pt) 2014-12-11
HUE037567T2 (hu) 2018-09-28
JP2007538089A (ja) 2007-12-27
AU2005247422B2 (en) 2010-12-02
AU2005247422A1 (en) 2005-12-08
SI1755554T1 (sl) 2015-03-31
EP3299013A1 (en) 2018-03-28
EP1755554A2 (en) 2007-02-28
JP5116469B2 (ja) 2013-01-09
DK2805712T3 (en) 2018-05-22
US20140370097A1 (en) 2014-12-18
CA2569549A1 (en) 2005-12-08
PL2805712T3 (pl) 2018-08-31
PL1755554T3 (pl) 2015-04-30
WO2005115332A2 (en) 2005-12-08
EP2805712B1 (en) 2018-02-28
LT2805712T (lt) 2018-07-10
WO2005115332A3 (en) 2006-05-04
HK1171971A1 (zh) 2013-04-12
EP2805712B2 (en) 2022-10-26
SI2805712T1 (en) 2018-07-31
CN1988886A (zh) 2007-06-27
US20080139519A1 (en) 2008-06-12
KR101148446B1 (ko) 2012-05-23
JP5473029B2 (ja) 2014-04-16
DK1755554T3 (en) 2014-12-15
AU2005247422B8 (en) 2010-12-09
ES2670706T5 (es) 2023-03-09
JP2013014597A (ja) 2013-01-24
MXPA06012874A (es) 2007-02-15
CN102600491A (zh) 2012-07-25
EP1755554B1 (en) 2014-11-12
HK1252557A1 (en) 2019-05-31
CA2569549C (en) 2010-09-21
IL179066A (en) 2014-07-31
DK2805712T4 (da) 2022-11-07
US8791096B2 (en) 2014-07-29
IL179066A0 (en) 2007-03-08
US10314785B2 (en) 2019-06-11
FI2805712T4 (fi) 2023-02-09
EP2805712A1 (en) 2014-11-26
GB0410995D0 (en) 2004-06-23
KR20070037436A (ko) 2007-04-04
CY1115948T1 (el) 2017-01-25
CN102600491B (zh) 2015-07-22
ES2525877T3 (es) 2014-12-30
PT2805712T (pt) 2018-05-24

Similar Documents

Publication Publication Date Title
JP5473029B2 (ja) グルココルチコステロイドの熱滅菌
CN1173702C (zh) 含有糖皮质激素的可药用吸入粉末及消毒该粉末的方法
US20120258939A1 (en) Pharmaceutical manufacturing process
HK1171971B (en) Heat sterilization of glucocorticosteroids
AU2012200155A1 (en) Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions
MX2007005681A (en) Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C14 Grant of patent or utility model
GR01 Patent grant
CX01 Expiry of patent term

Granted publication date: 20121107

CX01 Expiry of patent term