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
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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Pulmonology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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
DK06017746.6T DK1832279T3 (da) 1998-11-03 1999-10-28 Fremgangsmåde til fremstilling af suspensioner indeholdende partikler med aktivt stof til brug for en indgivelse ved inhalation
DK99955895T DK1126823T3 (da) 1998-11-03 1999-10-28 Fremgangsmåde til fremstilling af sterilt terapeutisk acceptabelt beclometason-dipropionat

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK06017746.6T DK1832279T3 (da) 1998-11-03 1999-10-28 Fremgangsmåde til fremstilling af suspensioner indeholdende partikler med aktivt stof til brug for en indgivelse ved inhalation

Country Status (26)

Country Link
US (1) US6464958B1 (da)
EP (2) EP1832279B1 (da)
JP (1) JP2002528484A (da)
KR (1) KR100783096B1 (da)
CN (1) CN1158997C (da)
AT (1) ATE352288T1 (da)
AU (1) AU762367B2 (da)
BR (2) BRPI9915251B8 (da)
CA (2) CA2614633C (da)
CY (2) CY1107659T1 (da)
CZ (2) CZ306939B6 (da)
DE (1) DE69935002T2 (da)
DK (2) DK1832279T3 (da)
EA (1) EA003228B1 (da)
ES (1) ES2281197T3 (da)
HU (2) HU230121B1 (da)
IT (1) IT1303692B1 (da)
NO (1) NO20012175L (da)
NZ (1) NZ511305A (da)
PL (1) PL195908B1 (da)
PT (1) PT1126823E (da)
SI (1) SI1126823T1 (da)
SK (2) SK288316B6 (da)
TR (1) TR200101209T2 (da)
WO (1) WO2000025746A2 (da)
ZA (1) ZA200103526B (da)

Families Citing this family (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU4990696A (en) * 1995-02-24 1996-09-11 Nanosystems L.L.C. Aerosols containing nanoparticle dispersions
IL142896A0 (en) 1998-11-02 2002-04-21 Elan Corp Plc Multiparticulate modified release composition
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
EP1476201B1 (en) 2002-02-19 2008-12-24 Resolution Chemicals Limited Solvent-based sterilisation of steroids
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
CA2500908A1 (en) * 2002-10-04 2004-04-22 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
US8912174B2 (en) * 2003-04-16 2014-12-16 Mylan Pharmaceuticals Inc. Formulations and methods for treating rhinosinusitis
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
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.
CA2546454A1 (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
ATE497787T1 (de) * 2004-03-12 2011-02-15 Cipla Ltd Sterilisationsprozess für steroide
GB0406515D0 (en) * 2004-03-23 2004-04-28 Novartis Ag Organic compounds
CA2559915C (en) 2004-03-23 2013-07-02 Novartis Ag Micronization of pharmaceutically active agents
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
EP2623095A1 (en) * 2004-11-16 2013-08-07 Elan Pharma International Limited Injectable nanoparticulate olanzapine formulations
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
EP1968547A1 (en) * 2005-11-29 2008-09-17 Farmabios S.p.A. Process for the preparation of micronised sterile steroids
JP2009543803A (ja) * 2006-07-12 2009-12-10 エラン・ファルマ・インターナショナル・リミテッド モダフィニルのナノ粒子製剤
WO2009074666A1 (en) * 2007-12-13 2009-06-18 Novartis Ag Organic compounds
KR20120023663A (ko) * 2009-05-25 2012-03-13 키에시 파르마슈티시 엣스. 피. 에이. 폐 계면활성제 및 스테로이드를 포함하는 치료적 조합
CN103501791B (zh) 2011-05-03 2016-05-18 奇斯药制品公司 用于通过吸入给药的改良皮质类固醇悬浮制剂
DK2704687T3 (da) 2011-05-04 2015-10-05 Chiesi Farma Spa Topisk formulering med en corticosteroid som aktiv bestanddel
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
NZ235222A (en) 1989-09-08 1992-11-25 Glaxo Group Ltd Inhalatory composition comprising salmeterol and beclomethasone dipropionate
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
NO20012175D0 (no) 2001-05-02
EP1126823A2 (en) 2001-08-29
EP1832279A3 (en) 2008-03-05
PL347908A1 (en) 2002-04-22
BR9915251A (pt) 2001-10-30
NZ511305A (en) 2003-07-25
DK1832279T3 (da) 2015-10-05
KR100783096B1 (ko) 2007-12-07
TR200101209T2 (tr) 2001-09-21
NO20012175L (no) 2001-07-02
CA2349268A1 (en) 2000-05-11
CZ2007211A3 (cs) 2017-09-27
CA2349268C (en) 2009-03-31
SK285487B6 (sk) 2007-02-01
AU1266600A (en) 2000-05-22
ES2281197T3 (es) 2007-09-16
PT1126823E (pt) 2007-04-30
BRPI9917701B1 (pt) 2016-07-19
SK5932001A3 (en) 2001-11-06
AU762367B2 (en) 2003-06-26
CZ306939B6 (cs) 2017-09-27
WO2000025746A2 (en) 2000-05-11
SI1126823T1 (sl) 2007-04-30
HU226734B1 (en) 2009-08-28
US6464958B1 (en) 2002-10-15
JP2002528484A (ja) 2002-09-03
PL195908B1 (pl) 2007-11-30
IT1303692B1 (it) 2001-02-23
CZ300650B6 (cs) 2009-07-08
CN1335766A (zh) 2002-02-13
BRPI9915251B8 (pt) 2021-05-25
ZA200103526B (en) 2002-06-03
CA2614633C (en) 2010-12-21
DE69935002D1 (de) 2007-03-15
SK288316B6 (sk) 2015-11-03
EP1832279A2 (en) 2007-09-12
ATE352288T1 (de) 2007-02-15
HU230121B1 (hu) 2015-08-28
BRPI9915251B1 (pt) 2015-09-01
DE69935002T2 (de) 2007-07-19
CZ20011541A3 (cs) 2001-09-12
CN1158997C (zh) 2004-07-28
EA003228B1 (ru) 2003-02-27
EP1126823B1 (en) 2007-01-24
CY1107659T1 (el) 2013-04-18
EP1832279B1 (en) 2015-07-01
CA2614633A1 (en) 2000-05-11
HU0700446D0 (en) 2007-08-28
EA200100397A1 (ru) 2001-10-22
WO2000025746A3 (en) 2000-10-26
KR20010075656A (ko) 2001-08-09
ITMI982364A1 (it) 2000-05-03
HUP0104230A2 (hu) 2002-03-28
CY1116943T1 (el) 2017-04-05
HUP0104230A3 (en) 2006-07-28

Similar Documents

Publication Publication Date Title
NO20012175D0 (no) Fremgangsmåte for fremstilling av suspensjoner av legemiddelpartikler for inhalering
BRPI0409381A (pt) formulações farmacêuticas nasais e métodos de utilizar as mesmas
TW200501983A (en) Uses of anti-insulin-like growth factor I receptor antibodies
ATE387430T1 (de) Verbindungen und zusammensetzungen zur abgabe aktiver wirkstoffe
HUP0104718A2 (hu) Mikronizált eplerenon kompozíciók és eljárás az előállításukra
KR970704422A (ko) 투여용 약제학적 조성물
FI20002215A0 (fi) Yhdistelmäpartikkelit
TW200612987A (en) Combination treatment for non-hematologic malignancies
AU644094B2 (en) Medicaments
EA200900451A1 (ru) Способ получения композиции эстрадиола с медленным высвобождением ( варианты ), микросферы эстрадиола и холестерина и способ для одновременной контрацепции и гормонозамещения
NO20001087D0 (no) Medikament for forlengelse av muskelfunksjon eller behandling av muskelforstyrrelser eller -sykdommer
BR0304821A (pt) Processo de preparação de uma suspensão estéril de partìculas de corticosteróide para administração por inalação
NO20005625L (no) Anvendelse av toremifen og dens metabolske analoger, og deres farmasoytisk akseptable salter, estere, N-oksider og blanding av disse, i fremstilling av et farmasoytisk preparat for behandling av prostataintraepitelisk neoplasi (PIN)
PL377345A1 (pl) Sposób wytwarzania sterylnych zawiesin wodnych do inhalacji, zawierających rozdrobnione do mikrocząstek krystaliczne składniki aktywne
AU2003233921A1 (en) Atomizable liposomes and their use for the pulmonary administration of active substances
DE60002885D1 (de) Wässrige formulierung zur nasalen verabreichung
NO20044496L (no) Torr pulver innhaleringssammensetning
BG107257A (en) Formulations containing a glucocorticoid drug for the treatment of bronchopulmonary diseases
TNSN05048A1 (en) Inhalation compositions with high drug ratios
DE60202299D1 (de) Pharmazeutische zusammensetzung enthaltend salmeterol und budesonid zur behandlung von atemkrankheiten
CA2295389A1 (en) Method of treatment of nausea, vomiting, and other disorders using estrogens