BRPI9915251B8 - um processo para a preparação de suspensões de partículas de medicamentos para serem administradas por inalação - Google Patents

um processo para a preparação de suspensões de partículas de medicamentos para serem administradas por inalação

Info

Publication number
BRPI9915251B8
BRPI9915251B8 BRPI9915251A BR9915251A BRPI9915251B8 BR PI9915251 B8 BRPI9915251 B8 BR PI9915251B8 BR PI9915251 A BRPI9915251 A BR PI9915251A BR 9915251 A BR9915251 A BR 9915251A BR PI9915251 B8 BRPI9915251 B8 BR PI9915251B8
Authority
BR
Brazil
Prior art keywords
inhalation
drug particles
suspensions
administered
preparation
Prior art date
Application number
BRPI9915251A
Other languages
English (en)
Other versions
BR9915251A (pt
BRPI9915251B1 (pt
Inventor
Malvotti Chiara
Bernini Eva
Brambilla Gaetano
Chiesi Paolo
Garzia Raffaella
Original Assignee
Chiesi Farm 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 Farm Spa filed Critical Chiesi Farm Spa
Publication of BR9915251A publication Critical patent/BR9915251A/pt
Publication of BRPI9915251B1 publication Critical patent/BRPI9915251B1/pt
Publication of BRPI9915251B8 publication Critical patent/BRPI9915251B8/pt

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)

Abstract

"um processo para a preparação de suspensões de partículas de medicamentos para serem administradas por inalação". a invenção diz respeito a um processo para a preparação de suspensões de partículas de medicamentos para aplicação por inalação, oferecendo partículas de tamanho e distribuição otimizados, dispersados homogeneamente no veículo. o processo, que é também adequado para a preparação de suspensões estéreis, inclui o passo de homogeneização e micronização da formulação por meio de um turbo emulsificador provido de uma turbina de alta potência, opcionalmente seguido de um tratamento em um homogeneizador de alta pressão. ainda um outro aspecto da invenção é dirigido a um processo para a preparação de dipropionato de beclometasona micronizado e estéril, por meio de irradiação gama.
BRPI9915251A 1998-11-03 1999-10-28 um processo para a preparação de suspensões de partículas de medicamentos para serem administradas por inalação BRPI9915251B8 (pt)

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 (3)

Publication Number Publication Date
BR9915251A BR9915251A (pt) 2001-10-30
BRPI9915251B1 BRPI9915251B1 (pt) 2015-09-01
BRPI9915251B8 true BRPI9915251B8 (pt) 2021-05-25

Family

ID=11380994

Family Applications (2)

Application Number Title Priority Date Filing Date
BRPI9915251A BRPI9915251B8 (pt) 1998-11-03 1999-10-28 um processo para a preparação de suspensões de partículas de medicamentos para serem administradas por inalação
BRPI9917701A BRPI9917701B1 (pt) 1998-11-03 1999-10-28 processo para a esterilização do dipropionato de beclometasona micronizado e dipropionato de beclometasona micronizado estéril terapeuticamente aceitável

Family Applications After (1)

Application Number Title Priority Date Filing Date
BRPI9917701A BRPI9917701B1 (pt) 1998-11-03 1999-10-28 processo para a esterilização do dipropionato de beclometasona micronizado e dipropionato de beclometasona micronizado estéril terapeuticamente aceitável

Country Status (26)

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

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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
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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
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CA2546454A1 (en) * 2003-11-18 2005-06-02 Yansong Shan Healthy pleasurable inhalation device
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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
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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
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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 (en) 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
DK1126823T3 (da) 2007-05-21
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
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

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B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B15G Petition not considered as such [chapter 15.7 patent gazette]

Free format text: NAO CONHECIDA A PETICAO NO 018080046131/SP DE 21/07/2008 EM VIRTUDE DO EXPOSTO NO ART. 219 INCISO II DA LPI, UMA VEZ QUE JA CONSTA PETICAO DE EXAME, VALIDA E ANTERIOR, DOS AUTOS DO PROCESSO.

B09B Patent application refused [chapter 9.2 patent gazette]

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B12B Appeal against refusal [chapter 12.2 patent gazette]
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]

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B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 01/09/2015, OBSERVADAS AS CONDICOES LEGAIS.

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