BR112021020694A2 - Composições farmacêuticas de bilastina estáveis e preservadas - Google Patents

Composições farmacêuticas de bilastina estáveis e preservadas

Info

Publication number
BR112021020694A2
BR112021020694A2 BR112021020694A BR112021020694A BR112021020694A2 BR 112021020694 A2 BR112021020694 A2 BR 112021020694A2 BR 112021020694 A BR112021020694 A BR 112021020694A BR 112021020694 A BR112021020694 A BR 112021020694A BR 112021020694 A2 BR112021020694 A2 BR 112021020694A2
Authority
BR
Brazil
Prior art keywords
bilastine
pharmaceutical composition
relates
preserved
stable
Prior art date
Application number
BR112021020694A
Other languages
English (en)
Inventor
Gonzalo Gorostiza Ana
Hernández Herrero Gonzalo
TATO CERDEIRAS Paloma
Marcianes Moreno Patricia
González Fernández Paula
Original Assignee
Faes Farma Sa
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 Faes Farma Sa filed Critical Faes Farma Sa
Publication of BR112021020694A2 publication Critical patent/BR112021020694A2/pt

Links

Classifications

    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

composições farmacêuticas de bilastina estáveis e preservadas. a invenção se refere a uma composição farmacêutica aquosa que compreende: a) bilastina, ou um sal ou solvato farmaceuticamente aceitável da mesma, b) cloreto de benzalcônio, em combinação com pelo menos um conservante adicional selecionado do grupo que compreende álcool feniletílico, álcool benzílico, benzoato de sódio, clorbutanol, fenoxietanol, cetrimida e sal de sódio do ácido 2-(etilmercuriomercapto) benzóico, c) um agente de suspensão e d) 2-hidroxipropil-ß-ciclodextrina; em que o ph da composição farmacêutica aquosa está entre 3,5 e 5,5. a invenção também se refere às referidas composições para uso no tratamento e/ou prevenção de um transtorno ou doença suscetível à melhoria por antagonismo do receptor de histamina h1 e/ou de uma doença sensível ao corticosteroide por meio da administração nasal. a invenção também se refere a um processo para preparar a composição farmacêutica aquosa acima mencionada.
BR112021020694A 2019-04-16 2020-04-15 Composições farmacêuticas de bilastina estáveis e preservadas BR112021020694A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP19382298.8A EP3725298A1 (en) 2019-04-16 2019-04-16 Stable and preserved pharmaceutical compositions of bilastine
PCT/EP2020/060521 WO2020212380A1 (en) 2019-04-16 2020-04-15 Stable and preserved pharmaceutical compositions of bilastine

Publications (1)

Publication Number Publication Date
BR112021020694A2 true BR112021020694A2 (pt) 2021-12-14

Family

ID=66240037

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021020694A BR112021020694A2 (pt) 2019-04-16 2020-04-15 Composições farmacêuticas de bilastina estáveis e preservadas

Country Status (8)

Country Link
US (1) US20230181555A1 (pt)
EP (1) EP3725298A1 (pt)
JP (1) JP2022529047A (pt)
CN (1) CN114007588A (pt)
BR (1) BR112021020694A2 (pt)
MX (1) MX2021012684A (pt)
TW (1) TW202103686A (pt)
WO (1) WO2020212380A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023156559A1 (en) * 2022-02-17 2023-08-24 Faes Farma, S.A. Bilastine composition for once-daily parenteral administration

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2048109B1 (es) 1992-07-20 1994-12-16 Espanola Prod Quimicos Procedimiento de preparacion de nuevos derivados piperidicos del bencimidazol.
ES2124167B1 (es) 1996-06-04 1999-09-16 Espanola Prod Quimicos Nuevos derivados del bencimidazol con actividad antihistaminica.
EP1713504B1 (en) 2004-01-30 2017-06-07 Zoetis Services LLC Antimicrobial preservatives to achieve multi-dose formulation using beta-cyclodextrins for liquid dosage forms
US20060045850A1 (en) 2004-08-30 2006-03-02 Qpharma, Llc Nasal delivery of cyclodextrin complexes of anti-inflammatory steroids
WO2007047253A2 (en) 2005-10-11 2007-04-26 Eastman Chemical Company Pharmaceutical formulations of cyclodextrins and antifungal azole compounds
EP1894559A1 (en) 2006-09-01 2008-03-05 PARI Pharma GmbH Means to solubilise steroids for inhalation
ES2493641T3 (es) * 2007-06-28 2014-09-12 Cydex Pharmaceuticals, Inc. Administración nasal de soluciones acuosas de corticosteroides
KR20100119632A (ko) 2009-05-01 2010-11-10 장환대 펜스
CA2822683C (en) 2011-01-04 2015-05-12 Ista Pharmaceuticals, Inc. Bepotastine compositions
KR101304341B1 (ko) 2011-09-19 2013-09-11 한미약품 주식회사 코르티코스테로이드, 항히스타민제 및 β-사이클로덱스트린을 포함하는, 안정성이 개선된 약학 조성물
EP3446692A1 (en) 2011-11-29 2019-02-27 Jurox Pty. Ltd. Methods of preserving injectable pharmaceutical compositions comprising a cyclodextrin and a hydrophobic drug
CN103736098A (zh) * 2013-12-27 2014-04-23 于运红 一种含有比拉斯汀及糠酸莫米松的鼻内给药用药物组合物
CN103784462A (zh) 2014-02-25 2014-05-14 宋俊智 包含比拉斯汀及甾族化合物的药物制剂

Also Published As

Publication number Publication date
EP3725298A1 (en) 2020-10-21
US20230181555A1 (en) 2023-06-15
WO2020212380A1 (en) 2020-10-22
TW202103686A (zh) 2021-02-01
CN114007588A (zh) 2022-02-01
JP2022529047A (ja) 2022-06-16
MX2021012684A (es) 2021-11-12

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 3A 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: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2737 DE 20-06-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.