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DK1572153T3 - Fremstilling af sterile vandige suspensioner, som omfatter mikroniserede krystallinske virksomme stoffer til inhalering - Google Patents

Fremstilling af sterile vandige suspensioner, som omfatter mikroniserede krystallinske virksomme stoffer til inhalering

Info

Publication number
DK1572153T3
DK1572153T3 DK03785852.9T DK03785852T DK1572153T3 DK 1572153 T3 DK1572153 T3 DK 1572153T3 DK 03785852 T DK03785852 T DK 03785852T DK 1572153 T3 DK1572153 T3 DK 1572153T3
Authority
DK
Denmark
Prior art keywords
preparation
active ingredients
sterile aqueous
aqueous suspensions
inhalation
Prior art date
Application number
DK03785852.9T
Other languages
English (en)
Inventor
Andrea Capocchi
Fausto Pivetti
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 DK1572153T3 publication Critical patent/DK1572153T3/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0017Filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1688Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/68Treatment of water, waste water, or sewage by addition of specified substances, e.g. trace elements, for ameliorating potable water
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2103/00Nature of the water, waste water, sewage or sludge to be treated
    • C02F2103/02Non-contaminated water, e.g. for industrial water supply
    • C02F2103/026Treating water for medical or cosmetic purposes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Otolaryngology (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
DK03785852.9T 2002-12-18 2003-12-17 Fremstilling af sterile vandige suspensioner, som omfatter mikroniserede krystallinske virksomme stoffer til inhalering DK1572153T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT002674A ITMI20022674A1 (it) 2002-12-18 2002-12-18 Procedimento per la preparazione di formulazioni sterili a base di principi attivi farmaceutici cristallini micronizzati da somministrare come sospensioni acquose per inalazione.
PCT/EP2003/014386 WO2004054545A1 (en) 2002-12-18 2003-12-17 Preparation of sterile aqueous suspensions comprising micronised crystalline active ingredients for inhalation

Publications (1)

Publication Number Publication Date
DK1572153T3 true DK1572153T3 (da) 2012-03-05

Family

ID=32587870

Family Applications (1)

Application Number Title Priority Date Filing Date
DK03785852.9T DK1572153T3 (da) 2002-12-18 2003-12-17 Fremstilling af sterile vandige suspensioner, som omfatter mikroniserede krystallinske virksomme stoffer til inhalering

Country Status (22)

Country Link
US (1) US8128909B2 (da)
EP (1) EP1572153B1 (da)
CN (1) CN100398095C (da)
AT (1) ATE544445T1 (da)
AU (1) AU2003294879A1 (da)
BR (1) BRPI0316908B8 (da)
CA (1) CA2510263C (da)
DK (1) DK1572153T3 (da)
EA (1) EA008122B1 (da)
ES (1) ES2379349T3 (da)
HR (1) HRP20050546B1 (da)
IT (1) ITMI20022674A1 (da)
MA (1) MA27702A1 (da)
ME (2) MEP35208A (da)
MX (1) MXPA05006441A (da)
PL (1) PL213704B1 (da)
PT (1) PT1572153E (da)
RS (1) RS52151B (da)
SI (1) SI1572153T1 (da)
UA (1) UA87655C2 (da)
WO (1) WO2004054545A1 (da)
ZA (1) ZA200504897B (da)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9704186D0 (sv) 1997-11-14 1997-11-14 Astra Ab New composition of matter
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
US8912174B2 (en) * 2003-04-16 2014-12-16 Mylan Pharmaceuticals Inc. Formulations and methods for treating rhinosinusitis
US7811606B2 (en) * 2003-04-16 2010-10-12 Dey, L.P. Nasal pharmaceutical formulations and methods of using the same
US9808471B2 (en) * 2003-04-16 2017-11-07 Mylan Specialty Lp Nasal pharmaceutical formulations and methods of using the same
ITMI20032054A1 (it) * 2003-10-22 2005-04-23 Monteres S R L Processo per la preparazione di sospensioni farmaceutiche da inalare.
PE20050941A1 (es) * 2003-12-16 2005-11-08 Nycomed Gmbh Suspensiones acuosas de ciclesonida para nebulizacion
CA2581999C (en) 2004-10-12 2013-04-23 Generics (Uk) Limited Preparation of suspension aerosol formulations
EP1949891A1 (en) * 2004-10-12 2008-07-30 Generics (UK) Limited Process for the preparation of suspension aerosol formulations, wherein the particles are formed by precipitation inside an aerosol canister
EP1683514B1 (en) 2005-01-20 2012-05-23 Eratech S.r.l. Process for the preparation of concentrated suspensions of drugs and kit thereof
EP1782797A1 (en) * 2005-11-02 2007-05-09 Pharmatex Italia Srl Process for the preparation of sterile powdered pharmaceutical compounds.
CA2683712A1 (en) * 2007-04-20 2009-01-15 Sun Pharmaceutical Industries Limited Pharmaceutical compositions
MX2010001311A (es) * 2007-07-31 2010-04-21 Otsuka Pharma Co Ltd Metodo para producir una suspensi?n de aripiprazol y formulacion liofilizada.
RU2496479C2 (ru) * 2007-12-13 2013-10-27 Новартис Аг Органические соединения
GB0806873D0 (en) * 2008-04-16 2008-05-21 Breath Ltd Steroid nebuliser formulation
CN101618019B (zh) * 2008-07-01 2011-08-03 上海通用药业股份有限公司 一种醋酸曲安奈德微粒及其制备方法和药物组合物
AU2012206621B2 (en) * 2011-01-12 2017-04-27 Intervet International B.V. Use of liquid medium exchange by cross flow filtration in the preparation of drug suspensions
HUE030016T2 (en) 2011-05-03 2017-04-28 Chiesi Farm Spa An improved suspension beclomethasone dipropionate formulation for inhalation administration
JP4954345B1 (ja) * 2011-07-06 2012-06-13 アピ株式会社 医薬品原薬の無菌化精製装置
PL3517541T3 (pl) * 2012-05-08 2020-12-28 Nicox Ophthalmics, Inc. Postać polimorficzna propionianu flutykazonu
DE102012221219B4 (de) * 2012-11-20 2014-05-28 Jesalis Pharma Gmbh Verfahren zur Vergrößerung der Partikelgröße kristalliner Wirkstoff-Mikropartikel
ES2793905T3 (es) 2014-09-09 2020-11-17 Vectura Ltd Formulación que comprende glicopirrolato, método y aparato
ES2764495T3 (es) * 2015-10-09 2020-06-03 Bgh Procedimiento para cristalizar clatratos hidratos y procedimiento de purificación de un líquido acuoso usando los clatratos hidratos así cristalizados
WO2024180569A1 (en) * 2023-03-01 2024-09-06 Ajaykumar Balraj Kanduri A synergistic aqueous nebulization suspension for management of infectious respiratory disorders and process of preparation

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2107715B (en) 1981-10-19 1985-11-13 Glaxo Group Ltd Micronised beclomethasone dipropionate monohydrate and powder inhalation compositions containing it
US6187765B1 (en) * 1997-10-09 2001-02-13 Schering Corporation Mometasone furoate suspensions for nebulization
HUP0101608A2 (hu) * 1998-04-18 2002-03-28 Glaxo Group Limited Aeroszol formájú gyógyszerkészítmény és eljárás előállítására
US6241969B1 (en) * 1998-06-26 2001-06-05 Elan Corporation Plc Aqueous compositions containing corticosteroids for nasal and pulmonary delivery
IT1303692B1 (it) * 1998-11-03 2001-02-23 Chiesi Farma Spa Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione.
GB0015981D0 (en) * 2000-06-29 2000-08-23 Glaxo Group Ltd Novel process for preparing crystalline particles
GB0016040D0 (en) 2000-06-29 2000-08-23 Glaxo Group Ltd Novel process for preparing crystalline particles
ATE418347T1 (de) 2002-02-19 2009-01-15 Resolution Chemicals Ltd Auf lösungsmitteln basierende sterilisation von steroiden

Also Published As

Publication number Publication date
HRP20050546A2 (en) 2005-10-31
PL213704B1 (pl) 2013-04-30
WO2004054545A1 (en) 2004-07-01
MA27702A1 (fr) 2006-01-02
RS52151B (sr) 2012-08-31
EA008122B1 (ru) 2007-04-27
CA2510263C (en) 2012-07-03
US20070140980A1 (en) 2007-06-21
MXPA05006441A (es) 2005-09-08
CN1735403A (zh) 2006-02-15
PT1572153E (pt) 2012-03-22
PL377345A1 (pl) 2006-01-23
ME01084B (me) 2011-05-10
SI1572153T1 (sl) 2012-05-31
HRP20050546B1 (hr) 2014-05-23
MEP35208A (en) 2011-02-10
RS72504A (sr) 2006-10-27
UA87655C2 (ru) 2009-08-10
EP1572153B1 (en) 2012-02-08
BRPI0316908B8 (pt) 2021-05-25
ATE544445T1 (de) 2012-02-15
AU2003294879A1 (en) 2004-07-09
HK1088217A1 (zh) 2006-11-03
CA2510263A1 (en) 2004-07-01
CN100398095C (zh) 2008-07-02
EP1572153A1 (en) 2005-09-14
ITMI20022674A1 (it) 2004-06-19
BRPI0316908B1 (pt) 2016-01-26
BR0316908A (pt) 2005-10-18
ZA200504897B (en) 2006-09-27
US8128909B2 (en) 2012-03-06
EA200500833A1 (ru) 2006-02-24
ES2379349T3 (es) 2012-04-25

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