BRPI0403316A - Formulações de solução farmacêutica em aerossol adequadas para inalação oral ou nasal contendo glucocorticóides estáveis ao armazenamento; método para formulações estabilizantes e uso de um estabilizador - Google Patents

Formulações de solução farmacêutica em aerossol adequadas para inalação oral ou nasal contendo glucocorticóides estáveis ao armazenamento; método para formulações estabilizantes e uso de um estabilizador

Info

Publication number
BRPI0403316A
BRPI0403316A BR0403316-7A BRPI0403316A BRPI0403316A BR PI0403316 A BRPI0403316 A BR PI0403316A BR PI0403316 A BRPI0403316 A BR PI0403316A BR PI0403316 A BRPI0403316 A BR PI0403316A
Authority
BR
Brazil
Prior art keywords
stabilizer
water
formulations
glucocorticoids
aerosol pharmaceutical
Prior art date
Application number
BR0403316-7A
Other languages
English (en)
Inventor
Julio Cesar Vega
Fabian De Bonis
Original Assignee
Pablo Cassara S R L Lab
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 Pablo Cassara S R L Lab filed Critical Pablo Cassara S R L Lab
Publication of BRPI0403316A publication Critical patent/BRPI0403316A/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0043—Nose
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Otolaryngology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

"FORMULAçõES DE SOLUçãO FARMACêUTICA EM AEROSSOL ADEQUADAS PARA INALAçãO ORAL OU NASAL CONTENDO GLUCOCORTICóIDES ESTáVEIS AO ARMAZENAMENTO; MéTODO PARA FORMULAçõES ESTABILIZANTES E USO DE UM ESTABILIZADOR". Formulações de solução farmacêutica em aerossol contendo glucocorticoesteróides estabilizados pela adição de água ou uma mistura de água e ácido cítrico, impedindo corrosão de elementos do container sob condições de armazenamento padrão são descritas. As formulações compreendem: - entre 0.05 e 1.0 % em peso de um glucocorticóide tendo cetona C-20 e grupo OH nos carbonos 17 e/ou 21 como substância ativa; - entre 0.10 e 3 % em peso de um estabilizador selecionado, selecionado entre água ou uma mistura de água e ácido orgânico selecionado entre ácido cítrico e ácido tartárico; - um co-solvente em quantidade suficiente para solubilizar a substância ativa; - opcionalmente um surfactante; e - propelente em quantidade suficiente para alcançar 100 % em peso de solução acabada. Glucocorticoesteróides tendo uma cetona C-20 e um grupo OH na posição C-17 e/ou 21 com substituintes variáveis, tendo muitos usos terapêuticos bem conhecidos, especialmente baseados em suas atividades antiinflamatórias. Estes tipos de esteróides, glucocorticoesteróides, e suas formulações farmacêuticas são úteis no tratamento de várias doenças incluindo doenças bronquiais e condições inflamatórias. Preferivelmente, o glucocorticóide é selecionado entre Triomcinolona Acetonide, budesonida, Dexametasona e betametasona 17-valerato. Um método para formulações de solução farmacêutica aerossol estabilizante contendo glucocorticóides suscetíveis a degradação oxidativa e uso de um estabilizador selecionado entre água e uma mistura de água e ácido orgânico selecionado entre ácido cítrico e ácido tartárico são também descritos.
BR0403316-7A 2003-10-30 2004-08-19 Formulações de solução farmacêutica em aerossol adequadas para inalação oral ou nasal contendo glucocorticóides estáveis ao armazenamento; método para formulações estabilizantes e uso de um estabilizador BRPI0403316A (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ARP030103969A AR041873A1 (es) 2003-10-30 2003-10-30 Una formulacion farmaceutica en aerosol adecuada para la inhalacion oral o nasal que contienen glucocorticoides en solucion estable al almacenamiento; un metodo para estabilzar formulaciones y uso de un agente estabilizante

Publications (1)

Publication Number Publication Date
BRPI0403316A true BRPI0403316A (pt) 2005-06-21

Family

ID=34397344

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0403316-7A BRPI0403316A (pt) 2003-10-30 2004-08-19 Formulações de solução farmacêutica em aerossol adequadas para inalação oral ou nasal contendo glucocorticóides estáveis ao armazenamento; método para formulações estabilizantes e uso de um estabilizador

Country Status (4)

Country Link
US (1) US20050095206A1 (pt)
EP (1) EP1527772A1 (pt)
AR (1) AR041873A1 (pt)
BR (1) BRPI0403316A (pt)

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* Cited by examiner, † Cited by third party
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ES2391563T5 (es) 2004-07-02 2022-10-26 Boehringer Ingelheim Int Formulaciones en suspensión de aerosol con TG 227 ea como agente propulsor
WO2007070875A1 (en) * 2005-12-15 2007-06-21 Aerosol Science Laboratories, Inc. Treatment of active infections and related compositions
DE102006017320A1 (de) 2006-04-11 2007-10-18 Boehringer Ingelheim Pharma Gmbh & Co. Kg Aerosolsuspensionsformulierungen mit TG 227 ea oder TG 134 a als Treibmittel
GB0808537D0 (en) 2008-05-12 2008-06-18 Archimedes Dev Ltd Compositions
SI2515855T1 (sl) * 2009-12-23 2014-08-29 Chiesi Farmaceutici S.P.A. KOMBINIRANA TERAPIJA ZA KOPB (v angl.: COPD)
WO2011135585A2 (en) * 2010-04-28 2011-11-03 Cadila Healthcare Limited Aqueous pharmaceutical solution of ciclesonide
US20120204871A1 (en) * 2011-02-10 2012-08-16 Julio Cesar Vega Stable, non-corrosive formulations for pressurized metered dose inhalers
CN109549935A (zh) * 2017-09-27 2019-04-02 天津金耀集团有限公司 一种通过溶液方式降低糖皮质激素粒径的方法
CN111939143A (zh) * 2019-05-16 2020-11-17 鲁南制药集团股份有限公司 一种布地奈德溶液型气雾剂及其制备方法
US11896719B2 (en) 2022-01-24 2024-02-13 Calliditas Therapeutics Ab Pharmaceutical compositions
US11904046B1 (en) * 2022-11-14 2024-02-20 Eton Pharmaceuticals, Inc. Hydrocortisone oral liquid formulations

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DE4003272A1 (de) * 1990-02-03 1991-08-08 Boehringer Ingelheim Kg Neue treibgasmischungen und ihre verwendung in arzneimittelzubereitungen
GB9202519D0 (en) * 1992-02-06 1992-03-25 Glaxo Group Ltd Medicaments
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IT1313553B1 (it) * 1999-07-23 2002-09-09 Chiesi Farma Spa Formulazioni ottimizzate costituite da soluzioni di steroidi dasomministrare per inalazione.
JP5392880B2 (ja) * 2000-05-22 2014-01-22 キエシ・フアルマチエウテイチ・ソチエタ・ペル・アチオニ 加圧式定量吸入器のための安定な製薬学的溶液製剤
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Also Published As

Publication number Publication date
AR041873A1 (es) 2005-06-01
US20050095206A1 (en) 2005-05-05
EP1527772A1 (en) 2005-05-04

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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]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 9A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2260 DE 29/04/2014.

B07F Notification of approval that there is no relation to art. 229 of lpi (pipeline patents) [chapter 7.6 patent gazette]

Free format text: NOTIFICACAO DE NAO ANUENCIA RELACIONADA COM O ART. 229 DA LPI