DK1126823T3 - Fremgangsmåde til fremstilling af sterilt terapeutisk acceptabelt beclometason-dipropionat - Google Patents

Fremgangsmåde til fremstilling af sterilt terapeutisk acceptabelt beclometason-dipropionat

Info

Publication number
DK1126823T3
DK1126823T3 DK99955895T DK99955895T DK1126823T3 DK 1126823 T3 DK1126823 T3 DK 1126823T3 DK 99955895 T DK99955895 T DK 99955895T DK 99955895 T DK99955895 T DK 99955895T DK 1126823 T3 DK1126823 T3 DK 1126823T3
Authority
DK
Denmark
Prior art keywords
preparation
sterile
therapeutically acceptable
beclometasone dipropionate
directed
Prior art date
Application number
DK99955895T
Other languages
Danish (da)
English (en)
Inventor
Eva Bernini
Chiara Malvolti
Raffaella Garzia
Gaetano Brambilla
Paolo Chiesi
Original Assignee
Chiesi Farma Spa
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 Chiesi Farma Spa filed Critical Chiesi Farma Spa
Application granted granted Critical
Publication of DK1126823T3 publication Critical patent/DK1126823T3/da

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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y10S977/906—Drug delivery
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y10S977/926—Topical chemical, e.g. cosmetic or sunscreen

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Otolaryngology (AREA)
  • Immunology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
DK99955895T 1998-11-03 1999-10-28 Fremgangsmåde til fremstilling af sterilt terapeutisk acceptabelt beclometason-dipropionat DK1126823T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT1998MI002364A IT1303692B1 (it) 1998-11-03 1998-11-03 Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione.
PCT/EP1999/008176 WO2000025746A2 (en) 1998-11-03 1999-10-28 A process for the preparation of suspensions of drug particles for inhalation delivery

Publications (1)

Publication Number Publication Date
DK1126823T3 true DK1126823T3 (da) 2007-05-21

Family

ID=11380994

Family Applications (2)

Application Number Title Priority Date Filing Date
DK99955895T DK1126823T3 (da) 1998-11-03 1999-10-28 Fremgangsmåde til fremstilling af sterilt terapeutisk acceptabelt beclometason-dipropionat
DK06017746.6T DK1832279T3 (en) 1998-11-03 1999-10-28 Process for preparing suspensions containing active substance particles for use by inhalation administration

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK06017746.6T DK1832279T3 (en) 1998-11-03 1999-10-28 Process for preparing suspensions containing active substance particles for use by inhalation administration

Country Status (26)

Country Link
US (1) US6464958B1 (cs)
EP (2) EP1126823B1 (cs)
JP (1) JP2002528484A (cs)
KR (1) KR100783096B1 (cs)
CN (1) CN1158997C (cs)
AT (1) ATE352288T1 (cs)
AU (1) AU762367B2 (cs)
BR (2) BRPI9917701B1 (cs)
CA (2) CA2614633C (cs)
CY (2) CY1107659T1 (cs)
CZ (2) CZ2007211A3 (cs)
DE (1) DE69935002T2 (cs)
DK (2) DK1126823T3 (cs)
EA (1) EA003228B1 (cs)
ES (1) ES2281197T3 (cs)
HU (2) HU226734B1 (cs)
IT (1) IT1303692B1 (cs)
NO (1) NO20012175L (cs)
NZ (1) NZ511305A (cs)
PL (1) PL195908B1 (cs)
PT (1) PT1126823E (cs)
SI (1) SI1126823T1 (cs)
SK (2) SK288316B6 (cs)
TR (1) TR200101209T2 (cs)
WO (1) WO2000025746A2 (cs)
ZA (1) ZA200103526B (cs)

Families Citing this family (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69633222T2 (de) * 1995-02-24 2005-09-08 Elan Pharma International Ltd. Nanopartikel-dispersionen enthaltende aerosole
CZ303495B6 (cs) 1998-11-02 2012-10-24 Elan Pharma International Limited Mnohocásticový modifikovane uvolnující prostredek a jeho použití, pevná orální dávkovací forma
AUPQ573300A0 (en) * 2000-02-21 2000-03-16 Australian Nuclear Science & Technology Organisation Controlled release ceramic particles, compositions thereof, processes of preparation and methods of use
NZ523693A (en) * 2000-07-10 2004-08-27 Chiron Corp Macrolide formulations for inhalation and methods of treatment of endobronchial infections
SG98420A1 (en) * 2000-07-13 2003-09-19 Purzer Pharmaceutical Co Ltd Method for transferring one or more active ingredients between different phase carriers
US6667344B2 (en) 2001-04-17 2003-12-23 Dey, L.P. Bronchodilating compositions and methods
US20030091513A1 (en) * 2001-10-03 2003-05-15 Mohsen Nahed M. Method to generate water soluble or nonwater soluble in nanoparticulates directly in suspension or dispersion media
US20030129242A1 (en) * 2002-01-04 2003-07-10 Bosch H. William Sterile filtered nanoparticulate formulations of budesonide and beclomethasone having tyloxapol as a surface stabilizer
DK1476201T3 (da) 2002-02-19 2009-03-30 Resolution Chemicals Ltd Solvent-baseret sterilisering af steroider
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
AU2003268380A1 (en) * 2002-10-04 2004-05-04 Elan Pharma International Limited Gamma irradiation of solid nanoparticulate active agents
ITMI20022674A1 (it) * 2002-12-18 2004-06-19 Chiesi Farma Spa Procedimento per la preparazione di formulazioni sterili a base di principi attivi farmaceutici cristallini micronizzati da somministrare come sospensioni acquose per inalazione.
US20040208833A1 (en) * 2003-02-04 2004-10-21 Elan Pharma International Ltd. Novel fluticasone formulations
WO2004073685A1 (en) * 2003-02-20 2004-09-02 Constant Research & Development Limited Dexamethasone-containing formulations for oral administration as well the process for manufacturing required therefor
EP1454636A1 (en) * 2003-03-04 2004-09-08 Dompé S.P.A. Sterilization of glucocorticoid drug particles for pulmonary delivery
US9808471B2 (en) * 2003-04-16 2017-11-07 Mylan Specialty Lp Nasal pharmaceutical formulations and methods of using the same
US7811606B2 (en) * 2003-04-16 2010-10-12 Dey, L.P. Nasal pharmaceutical formulations and methods of using the same
US8912174B2 (en) * 2003-04-16 2014-12-16 Mylan Pharmaceuticals Inc. Formulations and methods for treating rhinosinusitis
US7842232B2 (en) * 2003-05-22 2010-11-30 Elan Pharma International, Ltd. Sterilization of dispersions of nanoparticulate active agents with gamma radiation
TWI359675B (en) 2003-07-10 2012-03-11 Dey L P Bronchodilating β-agonist compositions
GB0319500D0 (en) * 2003-08-19 2003-09-17 Resolution Chemicals Ltd Particle-size reduction apparatus,and use thereof
ITMI20032054A1 (it) * 2003-10-22 2005-04-23 Monteres S R L Processo per la preparazione di sospensioni farmaceutiche da inalare.
AU2004291542A1 (en) * 2003-11-18 2005-06-02 Yansong Shan Healthy pleasurable inhalation device
PE20050941A1 (es) 2003-12-16 2005-11-08 Nycomed Gmbh Suspensiones acuosas de ciclesonida para nebulizacion
US7892483B2 (en) * 2004-03-12 2011-02-22 Cipla Limited Sterilization process
GB0406515D0 (en) * 2004-03-23 2004-04-28 Novartis Ag Organic compounds
KR101179393B1 (ko) 2004-03-23 2012-09-07 노파르티스 아게 제약 조성물
ITMI20040795A1 (it) * 2004-04-23 2004-07-23 Eratech S R L Composizione farmaceutica solida secca suo processo di preparazione e sospensione acquosa stabile ottenuta dalla stessa
GB0410995D0 (en) 2004-05-17 2004-06-23 Norton Healthcare Ltd Heat sterilization of glucocorticosteroids
GB0425266D0 (en) 2004-11-16 2004-12-15 Norton Healthcare Ltd Pharmaceutical manufacturing process
JP5324098B2 (ja) * 2004-11-16 2013-10-23 アルケルメス ファーマ アイルランド リミテッド 注射可能なナノ粒子のオランザピン製剤
GB0427568D0 (en) * 2004-12-16 2005-01-19 Resolution Chemicals Ltd Particle-size reduction apparatus, and the use thereof
ES2388287T3 (es) 2005-01-20 2012-10-11 Eratech S.R.L. Procedimiento para la preparación de suspensiones concentradas de fármacos y kit correspondiente
US20090252801A1 (en) * 2005-11-29 2009-10-08 Farmbios S.P.A. Process for the Preparation of Micronised Sterile Steroids
KR20090031618A (ko) * 2006-07-12 2009-03-26 엘란 코포레이션, 피엘씨 나노입자형 모다피닐 제제
AU2008334547B2 (en) * 2007-12-13 2011-06-30 Novartis Ag Organic compounds
BRPI1008165B1 (pt) * 2009-05-25 2020-02-27 Chiesi Farmaceutici S.P.A. Uma combinação terapêutica compreendendo um surfactante pulmonar e um esteróide
BR112013027391A2 (pt) 2011-05-03 2017-01-17 Chiesi Farmaceutic S P A formulação farmacêutica, frasco e kit
DK2704687T3 (en) 2011-05-04 2015-10-05 Chiesi Farma Spa Topical formulation having a corticosteroid as an active ingredient
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
TWI773641B (zh) * 2015-05-08 2022-08-11 日商活效製藥股份有限公司 含有糖皮質類固醇（ｇｌｕｃｏｃｏｒｔｉｃｏｉｄｓ）之奈米微粒子之水性懸浮液劑
WO2023136787A1 (en) * 2022-01-17 2023-07-20 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Process for the preparation of a sterile, homogeneous suspension for inhalation by nebulization

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK0416950T3 (da) * 1989-09-08 1993-10-11 Glaxo Group Ltd Medikamenter
US5126123A (en) * 1990-06-28 1992-06-30 Glaxo, Inc. Aerosol drug formulations
JPH0486921A (ja) * 1990-07-31 1992-03-19 Omron Corp 近似推論のための知識ベース形成方法および装置
US5046326A (en) 1990-10-24 1991-09-10 Thermo King Corporation Transport refrigeration system
IT1243911B (it) * 1990-11-19 1994-06-28 Zambon Spa Composizioni per la terapia mucolitica
GB9202519D0 (en) * 1992-02-06 1992-03-25 Glaxo Group Ltd Medicaments
IL101387A (en) * 1992-03-26 1999-11-30 Pharmos Ltd Emulsion with enhanced topical and/or transdermal systemic effect utilizing submicron oil droplets
UY24147A1 (es) * 1995-01-20 1996-02-02 Gruenenthal Chemie Procedimiento y dispositivo para preparar composiciones dispersables por aspersion de aerosoles
US6135628A (en) * 1995-10-13 2000-10-24 Boehringer Ingelheim Pharmceuticals, Inc. Method and apparatus for homogenizing aerosol formulations
IT1286496B1 (it) * 1996-11-20 1998-07-15 Leetrim Ltd Dublin Composizione farmaceutica orale ad attivita' antipiretica,analgesica ed antiinfiammatoria
SE9704186D0 (sv) * 1997-11-14 1997-11-14 Astra Ab New composition of matter

Also Published As

Publication number Publication date
KR20010075656A (ko) 2001-08-09
EP1126823A2 (en) 2001-08-29
HUP0104230A3 (en) 2006-07-28
CY1116943T1 (el) 2017-04-05
IT1303692B1 (it) 2001-02-23
EP1832279A3 (en) 2008-03-05
PL195908B1 (pl) 2007-11-30
ES2281197T3 (es) 2007-09-16
CA2349268A1 (en) 2000-05-11
KR100783096B1 (ko) 2007-12-07
HU0700446D0 (en) 2007-08-28
SK285487B6 (sk) 2007-02-01
SK5932001A3 (en) 2001-11-06
TR200101209T2 (tr) 2001-09-21
HUP0104230A2 (hu) 2002-03-28
ATE352288T1 (de) 2007-02-15
SK288316B6 (sk) 2015-11-03
US6464958B1 (en) 2002-10-15
WO2000025746A3 (en) 2000-10-26
SI1126823T1 (sl) 2007-04-30
DK1832279T3 (en) 2015-10-05
CA2614633C (en) 2010-12-21
NZ511305A (en) 2003-07-25
EA200100397A1 (ru) 2001-10-22
EP1126823B1 (en) 2007-01-24
CA2349268C (en) 2009-03-31
BR9915251A (pt) 2001-10-30
WO2000025746A2 (en) 2000-05-11
CA2614633A1 (en) 2000-05-11
NO20012175L (no) 2001-07-02
CZ300650B6 (cs) 2009-07-08
CZ306939B6 (cs) 2017-09-27
DE69935002D1 (de) 2007-03-15
ZA200103526B (en) 2002-06-03
CZ2007211A3 (cs) 2017-09-27
NO20012175D0 (no) 2001-05-02
CY1107659T1 (el) 2013-04-18
HU226734B1 (en) 2009-08-28
PT1126823E (pt) 2007-04-30
CN1335766A (zh) 2002-02-13
BRPI9917701B1 (pt) 2016-07-19
CZ20011541A3 (cs) 2001-09-12
EP1832279A2 (en) 2007-09-12
ITMI982364A1 (it) 2000-05-03
JP2002528484A (ja) 2002-09-03
AU1266600A (en) 2000-05-22
CN1158997C (zh) 2004-07-28
DE69935002T2 (de) 2007-07-19
HU230121B1 (hu) 2015-08-28
BRPI9915251B8 (pt) 2021-05-25
EP1832279B1 (en) 2015-07-01
EA003228B1 (ru) 2003-02-27
AU762367B2 (en) 2003-06-26
BRPI9915251B1 (pt) 2015-09-01
PL347908A1 (en) 2002-04-22

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