BR112012026938A2 - Composição à base de fexofenadina e seu processo de preparação. - Google Patents

Composição à base de fexofenadina e seu processo de preparação.

Info

Publication number
BR112012026938A2
BR112012026938A2 BR112012026938A BR112012026938A BR112012026938A2 BR 112012026938 A2 BR112012026938 A2 BR 112012026938A2 BR 112012026938 A BR112012026938 A BR 112012026938A BR 112012026938 A BR112012026938 A BR 112012026938A BR 112012026938 A2 BR112012026938 A2 BR 112012026938A2
Authority
BR
Brazil
Prior art keywords
fexofenadine
preparation process
based composition
hot melt
melt coating
Prior art date
Application number
BR112012026938A
Other languages
English (en)
Inventor
Lesot Axelle
Lamoureux Gael
Original Assignee
Sanofi 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42797556&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112012026938(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Sa filed Critical Sanofi Sa
Publication of BR112012026938A2 publication Critical patent/BR112012026938A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate 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
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005Coating of tablets or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • 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
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5015Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/04Antipruritics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Communicable Diseases (AREA)
  • Otolaryngology (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Paints Or Removers (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

COMPOSIÇÃO À BASE DE FEXOFENADINA E SEU PROCESSO DE PREPARAÇÃO. A presente invenção refere-se a grândulos de fexofenadina, a uma composição contendo-os e a um processo para o revestimento por fusão a quente de fexofenadina. O processo para o revestimento por fusão a quente de fexofenadina permite um mascaramento eficiente de seu sabor amargo sem, entretanto, retardar inaceitavelmente sua dissolução.
BR112012026938A 2010-04-21 2011-04-20 Composição à base de fexofenadina e seu processo de preparação. BR112012026938A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1053034A FR2959130A1 (fr) 2010-04-21 2010-04-21 Procede de preparation de compositions pharmaceutiques destinees a l'administration par voie orale comprenant un ou plusieurs principes actifs et les compositions les comprenant.
PCT/IB2011/002000 WO2011151733A2 (en) 2010-04-21 2011-04-20 Fexofenadine-based composition and preparation process therefor

Publications (1)

Publication Number Publication Date
BR112012026938A2 true BR112012026938A2 (pt) 2017-10-03

Family

ID=42797556

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112012026596A BR112012026596A2 (pt) 2010-04-21 2011-04-20 método para preparar composições farmacêuticas pretendidas para administração oral compreendendo um ou mais ingredientes ativos e as composições que compreendem as mesmas
BR112012026938A BR112012026938A2 (pt) 2010-04-21 2011-04-20 Composição à base de fexofenadina e seu processo de preparação.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
BR112012026596A BR112012026596A2 (pt) 2010-04-21 2011-04-20 método para preparar composições farmacêuticas pretendidas para administração oral compreendendo um ou mais ingredientes ativos e as composições que compreendem as mesmas

Country Status (22)

Country Link
US (2) US20130251794A1 (pt)
EP (2) EP2560612B1 (pt)
JP (2) JP2013525340A (pt)
KR (2) KR20130094716A (pt)
CN (2) CN103002874B (pt)
AR (2) AR081539A1 (pt)
AU (2) AU2011244020A1 (pt)
BR (2) BR112012026596A2 (pt)
CA (2) CA2796816A1 (pt)
CL (2) CL2012002898A1 (pt)
CO (2) CO6620042A2 (pt)
EA (2) EA201291089A1 (pt)
ES (2) ES2527390T3 (pt)
FR (1) FR2959130A1 (pt)
IL (2) IL222578A0 (pt)
MA (2) MA34226B1 (pt)
MX (1) MX2012012275A (pt)
PL (2) PL2560612T3 (pt)
SG (3) SG184950A1 (pt)
TW (2) TWI478713B (pt)
UY (2) UY33350A (pt)
WO (2) WO2011132167A1 (pt)

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FR2999937B1 (fr) * 2012-12-21 2015-01-09 Sanofi Sa Unite solide a haute teneur en fexofenadine et son procede de preparation
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CN103610645B (zh) * 2013-11-25 2016-05-11 浙江万晟药业有限公司 一种非索非那定盐酸盐的药物组合物及制备方法
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JP2023549381A (ja) 2020-11-18 2023-11-24 バイオファーマ・シナジーズ,エス.エル. 抗ヒスタミン活性化合物を含む口内分散性粉末組成物
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WO2023126637A1 (en) * 2021-12-29 2023-07-06 Opella Healthcare Group Sas Compositions containing fexofenadine

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Also Published As

Publication number Publication date
CN103002874A (zh) 2013-03-27
FR2959130A1 (fr) 2011-10-28
TW201204415A (en) 2012-02-01
MA34226B1 (fr) 2013-05-02
SG10201506708UA (en) 2015-09-29
AR081539A1 (es) 2012-10-03
EP2560613A2 (en) 2013-02-27
CO6620043A2 (es) 2013-02-15
MX2012012275A (es) 2012-11-16
AU2011244020A1 (en) 2012-11-08
WO2011132167A1 (en) 2011-10-27
JP2013525340A (ja) 2013-06-20
EP2560612A1 (en) 2013-02-27
CN103002874B (zh) 2015-04-08
WO2011151733A3 (en) 2012-01-26
SG184951A1 (en) 2012-11-29
ES2525163T3 (es) 2014-12-18
EP2560612B1 (en) 2014-09-03
IL222578A0 (en) 2012-12-31
CA2796816A1 (en) 2011-12-08
UY33351A (es) 2011-12-01
AR080934A1 (es) 2012-05-16
KR20130094716A (ko) 2013-08-26
PL2560613T3 (pl) 2015-03-31
PL2560612T3 (pl) 2015-03-31
TW201206434A (en) 2012-02-16
EA201291089A1 (ru) 2013-05-30
KR20130080428A (ko) 2013-07-12
AU2011262319A1 (en) 2012-11-08
CA2796821A1 (en) 2011-10-27
CN102946857A (zh) 2013-02-27
EP2560613B1 (en) 2014-10-15
IL222576A0 (en) 2012-12-31
TWI478713B (zh) 2015-04-01
BR112012026596A2 (pt) 2016-07-12
ES2527390T3 (es) 2015-01-23
JP2013525341A (ja) 2013-06-20
US20130183382A1 (en) 2013-07-18
SG184950A1 (en) 2012-11-29
EA201291088A1 (ru) 2013-03-29
US20130251794A1 (en) 2013-09-26
WO2011151733A2 (en) 2011-12-08
MA34227B1 (fr) 2013-05-02
CL2012002898A1 (es) 2013-03-01
CO6620042A2 (es) 2013-02-15
UY33350A (es) 2011-12-01
CL2012002909A1 (es) 2013-01-25

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