BR112022010875A2 - Comprimido deglutível revestido por película, processo para preparar o comprimido, e, uso de um comprimido - Google Patents

Comprimido deglutível revestido por película, processo para preparar o comprimido, e, uso de um comprimido

Info

Publication number
BR112022010875A2
BR112022010875A2 BR112022010875A BR112022010875A BR112022010875A2 BR 112022010875 A2 BR112022010875 A2 BR 112022010875A2 BR 112022010875 A BR112022010875 A BR 112022010875A BR 112022010875 A BR112022010875 A BR 112022010875A BR 112022010875 A2 BR112022010875 A2 BR 112022010875A2
Authority
BR
Brazil
Prior art keywords
tablet
film
coated
swallowable
prepare
Prior art date
Application number
BR112022010875A
Other languages
English (en)
Inventor
NOGUEIRAS NIETO Luis
Alvarez Fernandez Lisardo
Kumar Rohit
Original Assignee
Synthon Bv
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 Synthon Bv filed Critical Synthon Bv
Publication of BR112022010875A2 publication Critical patent/BR112022010875A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • A61K31/41521,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • 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
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

COMPRIMIDO DEGLUTÍVEL REVESTIDO POR PELÍCULA, PROCESSO PARA PREPARAR O COMPRIMIDO, E, USO DE UM COMPRIMIDO. A presente invenção se refere a um comprimido deglutível revestido por película que compreende eltrombopague bis(monoetanolamina) e excipientes farmaceuticamente aceitáveis que compreendem silicato de cálcio como diluente. A invenção se refere adicionalmente ao uso do dito comprimido como um medicamento, particularmente no tratamento de trombocitopenia imune (ITP), trombocitopenia em pacientes com vírus da hepatite C crônica (HCV) e anemia aplástica grave (SAA).
BR112022010875A 2019-12-06 2020-12-04 Comprimido deglutível revestido por película, processo para preparar o comprimido, e, uso de um comprimido BR112022010875A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP19214295 2019-12-06
PCT/EP2020/084723 WO2021110959A1 (en) 2019-12-06 2020-12-04 Pharmaceutical composition comprising eltrombopag bis(monoethanolamine)

Publications (1)

Publication Number Publication Date
BR112022010875A2 true BR112022010875A2 (pt) 2022-08-23

Family

ID=68835041

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022010875A BR112022010875A2 (pt) 2019-12-06 2020-12-04 Comprimido deglutível revestido por película, processo para preparar o comprimido, e, uso de um comprimido

Country Status (6)

Country Link
US (1) US20230022228A1 (pt)
EP (1) EP4069204A1 (pt)
AU (1) AU2020397233A1 (pt)
BR (1) BR112022010875A2 (pt)
CA (1) CA3160779A1 (pt)
WO (1) WO2021110959A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116637091B (zh) * 2023-07-24 2023-10-03 山东则正医药技术有限公司 一种艾曲波帕乙醇胺口溶膜及其制备方法和应用

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CY2010012I2 (el) 2000-05-25 2020-05-29 Novartis Ag Μιμητικα θρομβοποιητινης
ECSP077628A (es) 2007-05-03 2008-12-30 Smithkline Beechman Corp Nueva composición farmacéutica
WO2015029074A2 (en) 2013-09-02 2015-03-05 Hetero Research Foundation Compositions of eltrombopag
CN107693515B (zh) 2016-08-08 2022-04-29 广东东阳光药业有限公司 含碱化剂和艾曲泊帕的药物组合物及其用途
WO2018078644A1 (en) * 2016-10-24 2018-05-03 Hetero Labs Limited Orally disintegrating tablets of eltrombopag
EP3395331B1 (en) 2017-04-26 2019-08-21 Alfred E. Tiefenbacher (GmbH & Co. KG) Pharmaceutical tablet composition comprising eltrombopag olamine
EP3409272B1 (en) 2018-03-07 2020-06-24 Alfred E. Tiefenbacher (GmbH & Co. KG) Pharmaceutical composition comprising eltrombopag olamine, reducing sugar, and polymeric binder

Also Published As

Publication number Publication date
AU2020397233A1 (en) 2022-06-30
EP4069204A1 (en) 2022-10-12
CA3160779A1 (en) 2021-06-10
WO2021110959A1 (en) 2021-06-10
US20230022228A1 (en) 2023-01-26

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