BRPI0408022A - testerilização de partìculas de droga beclometasona para liberação pulmonar - Google Patents

testerilização de partìculas de droga beclometasona para liberação pulmonar

Info

Publication number
BRPI0408022A
BRPI0408022A BRPI0408022-0A BRPI0408022A BRPI0408022A BR PI0408022 A BRPI0408022 A BR PI0408022A BR PI0408022 A BRPI0408022 A BR PI0408022A BR PI0408022 A BRPI0408022 A BR PI0408022A
Authority
BR
Brazil
Prior art keywords
sterilization
pulmonary
release
drug
beclomethasone
Prior art date
Application number
BRPI0408022-0A
Other languages
English (en)
Inventor
Marco Gentile
Maria Concetta Dragani
Marco Dell Uomo
Original Assignee
Dompe 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 Dompe Spa filed Critical Dompe Spa
Publication of BRPI0408022A publication Critical patent/BRPI0408022A/pt
Publication of BRPI0408022B1 publication Critical patent/BRPI0408022B1/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J7/00—Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of two carbon atoms
    • 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
    • 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
    • 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
    • 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
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • 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
    • 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
    • C07J5/0007—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 not substituted in position 17 alfa
    • C07J5/0015—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 not substituted in position 17 alfa not substituted in position 16
    • 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
    • C07J5/0046—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 substituted in position 17 alfa
    • C07J5/0061—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 substituted in position 17 alfa substituted in position 16
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J51/00—Normal steroids with unmodified cyclopenta(a)hydrophenanthrene skeleton not provided for in groups C07J1/00 - C07J43/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J75/00—Processes for the preparation of steroids in general
    • 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
    • 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)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Abstract

"ESTERILIZAçãO DE PARTìCULAS DE DROGA BECLOMETASONA PARA LIBERAçãO PULMONAR". A presente invenção refere-se a um processo para esterilização de substâncias medicinais sólidas insolúveis em água. O processo providencia a esterilizado de substâncias de droga, adequadas para administração pulmonar. Em particular, o processo é usado em instalações industriais para produção de formulações de glicocorticóides estéreis para liberação por inalação, de modo a evitar quaisquer modificações na distribuição do tamanho de partícula e no perfil de impurezas da droga. O processo é realizado por aquecimento de uma mistura de, apenas glicocorticóide micronizado e água purificada, preferivelmente a uma temperatura de cerca de 120<198>C por 20 minutos. O processo é particularmente eficiente e económico para esterilização a vapor de dipropionato de beclometasona em formulações para liberação pulmonar.
BRPI0408022-0A 2003-03-04 2004-03-02 Processo para esterilização a vapor de beclometasona BRPI0408022B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP03004726A EP1454636A1 (en) 2003-03-04 2003-03-04 Sterilization of glucocorticoid drug particles for pulmonary delivery
EP03004726.0 2003-03-04
PCT/EP2004/050235 WO2004078102A2 (en) 2003-03-04 2004-03-02 Sterilization of beclomethasone drug particles for pulmonary delivery

Publications (2)

Publication Number Publication Date
BRPI0408022A true BRPI0408022A (pt) 2006-02-14
BRPI0408022B1 BRPI0408022B1 (pt) 2018-01-23

Family

ID=32798759

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0408022-0A BRPI0408022B1 (pt) 2003-03-04 2004-03-02 Processo para esterilização a vapor de beclometasona

Country Status (15)

Country Link
US (1) US20060140816A1 (pt)
EP (2) EP1454636A1 (pt)
JP (1) JP4712689B2 (pt)
AT (1) ATE360443T1 (pt)
BR (1) BRPI0408022B1 (pt)
CY (1) CY1106732T1 (pt)
DE (1) DE602004006089T2 (pt)
DK (1) DK1599233T3 (pt)
ES (1) ES2285436T3 (pt)
MX (1) MXPA05009348A (pt)
PL (1) PL1599233T3 (pt)
PT (1) PT1599233E (pt)
RU (1) RU2336905C2 (pt)
SI (1) SI1599233T1 (pt)
WO (1) WO2004078102A2 (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1626742A1 (en) 2003-05-22 2006-02-22 Elan Pharma International Limited Sterilization of dispersions of nanoparticulate active agents with gamma radiation
PE20050941A1 (es) 2003-12-16 2005-11-08 Nycomed Gmbh Suspensiones acuosas de ciclesonida para nebulizacion
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
ES2612257T3 (es) 2011-05-03 2017-05-16 Chiesi Farmaceutici S.P.A. Formulación de suspensión mejorada de dipropionato de beclometasona para administración mediante inhalación
JP5792240B2 (ja) * 2012-08-27 2015-10-07 武夫 西 注射シミュレータ用模擬剤及びその製造方法と製造装置
EP3386483A4 (en) * 2015-12-07 2019-06-05 Emcure Pharmaceuticals Limited STERILE PARENTERAL SUSPENSIONS

Family Cites Families (9)

* Cited by examiner, † Cited by third party
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
US5158761A (en) * 1989-04-05 1992-10-27 Toko Yakuhin Kogyo Kabushiki Kaisha Spray gel base and spray gel preparation using thereof
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.
BR0115584A (pt) * 2000-11-24 2003-09-23 Breath Ltd Esterilização de produtos farmacêuticos
JP4364486B2 (ja) * 2002-07-02 2009-11-18 帝人株式会社 無菌水性懸濁製剤

Also Published As

Publication number Publication date
JP4712689B2 (ja) 2011-06-29
DE602004006089D1 (de) 2007-06-06
RU2005130637A (ru) 2006-01-27
RU2336905C2 (ru) 2008-10-27
JP2007527364A (ja) 2007-09-27
MXPA05009348A (es) 2005-11-04
SI1599233T1 (sl) 2007-10-31
ATE360443T1 (de) 2007-05-15
ES2285436T3 (es) 2007-11-16
DE602004006089T2 (de) 2008-01-10
WO2004078102A2 (en) 2004-09-16
BRPI0408022B1 (pt) 2018-01-23
EP1454636A1 (en) 2004-09-08
WO2004078102A3 (en) 2004-11-18
CY1106732T1 (el) 2012-05-23
PL1599233T3 (pl) 2007-10-31
EP1599233A2 (en) 2005-11-30
EP1599233B1 (en) 2007-04-25
US20060140816A1 (en) 2006-06-29
PT1599233E (pt) 2007-07-26
DK1599233T3 (da) 2007-09-17

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B25A Requested transfer of rights approved

Owner name: DOMPE S.P.A. (IT)

B25A Requested transfer of rights approved

Owner name: DOMPE FARMACEUTICI S.P.A (IT)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]
B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 16A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: REFERENTE AO DESPACHO 21.6 PUBLICADO NA RPI 2556 DE 2019-12-31