PE20220593A1 - Composiciones comprimidas de macitentan, metodos y usos de las mismas - Google Patents

Composiciones comprimidas de macitentan, metodos y usos de las mismas

Info

Publication number
PE20220593A1
PE20220593A1 PE2021002203A PE2021002203A PE20220593A1 PE 20220593 A1 PE20220593 A1 PE 20220593A1 PE 2021002203 A PE2021002203 A PE 2021002203A PE 2021002203 A PE2021002203 A PE 2021002203A PE 20220593 A1 PE20220593 A1 PE 20220593A1
Authority
PE
Peru
Prior art keywords
macitentan
methods
compressed compositions
list consisting
composition
Prior art date
Application number
PE2021002203A
Other languages
English (en)
Inventor
Serra João Pedro Silva
De Oliveira Ricardo Jose Camilo Ferreira
Original Assignee
Tecnimede Soc Tecnico Medicinal 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 Tecnimede Soc Tecnico Medicinal Sa filed Critical Tecnimede Soc Tecnico Medicinal Sa
Publication of PE20220593A1 publication Critical patent/PE20220593A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical 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
    • A61K9/2013Organic 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
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/2022Organic 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pulmonology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Referido a una composicion comprimida que comprende una cantidad terapeuticamente eficaz de macitentan; un diluyente de alcohol de azucar seleccionado de una lista que consiste en: maltitol, xilitol, entre otros; un tensioactivo seleccionado de una lista que consiste en: dodecilsulfato de sodio, polisorbato 80 o una mezcla de los mismos. Tambien se refiere a procedimiento para preparar dicha composicion y su uso en el tratamiento de hipertension arterial pulmonar.
PE2021002203A 2019-07-05 2020-07-03 Composiciones comprimidas de macitentan, metodos y usos de las mismas PE20220593A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PT11563219 2019-07-05
EP19185065 2019-07-08
PCT/IB2020/056304 WO2021005478A1 (en) 2019-07-05 2020-07-03 Compressed macitentan compositions, methods and uses thereof

Publications (1)

Publication Number Publication Date
PE20220593A1 true PE20220593A1 (es) 2022-04-22

Family

ID=71899791

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2021002203A PE20220593A1 (es) 2019-07-05 2020-07-03 Composiciones comprimidas de macitentan, metodos y usos de las mismas

Country Status (11)

Country Link
US (1) US20220249381A1 (es)
EP (1) EP3993777A1 (es)
CN (1) CN114096239B (es)
AU (1) AU2020309223A1 (es)
BR (1) BR112022000117A2 (es)
CA (1) CA3144613A1 (es)
CL (1) CL2022000008A1 (es)
CO (1) CO2021017646A2 (es)
MX (1) MX2022000267A (es)
PE (1) PE20220593A1 (es)
WO (1) WO2021005478A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202317119A (zh) * 2021-06-11 2023-05-01 瑞士商艾克泰聯製藥有限公司 用於口服投予之分散錠
EP4154873A1 (en) * 2021-09-22 2023-03-29 Sanovel Ilac Sanayi Ve Ticaret A.S. The tablet comprising macitentan
WO2023128898A1 (en) * 2021-12-30 2023-07-06 Humanis Saglik Anonim Sirketi Pharmaceutical compositions comprising macitentan as active ingredient and other relevant excipients

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7094781B2 (en) 2000-12-18 2006-08-22 Actelion Pharmaceuticals Ltd. Sulfamides and their use as endothelin receptor antagonists
SI1928409T1 (sl) 2005-09-12 2012-12-31 Actelion Pharmaceuticals Ltd. Stabilni farmacevtski sestavek, ki obsega pirimidin-sulfamid
NZ592528A (en) 2008-11-17 2013-05-31 Nycomed Pharma As Improved dissolution stability of calcium carbonate tablets
DE14721256T1 (de) 2013-04-22 2017-03-16 Sandoz Ag Pharmazeutische zusammensetzungen mit kristallinem macitentan
CN104411691B (zh) * 2013-06-14 2016-05-25 杭州普晒医药科技有限公司 马西替坦晶体及其制备方法、其药物组合物和用途
IN201641002749A (es) 2016-01-25 2017-09-15 Hetero Research Foundation
CN107913256A (zh) * 2016-10-08 2018-04-17 郑州泰丰制药有限公司 一种治疗肺动脉高压的马西替坦口腔崩解片及其制备方法
WO2018153925A1 (en) * 2017-02-22 2018-08-30 Amneal Pharmaceuticals Company Gmbh Stable pharmaceutical compositions comprising macitentan
CN109260163A (zh) * 2018-10-07 2019-01-25 威海云睿信息科技有限公司 一种马西替坦片剂组合物

Also Published As

Publication number Publication date
US20220249381A1 (en) 2022-08-11
CN114096239B (zh) 2024-04-12
EP3993777A1 (en) 2022-05-11
CL2022000008A1 (es) 2022-10-07
CN114096239A (zh) 2022-02-25
MX2022000267A (es) 2022-02-03
CO2021017646A2 (es) 2022-01-17
WO2021005478A1 (en) 2021-01-14
CA3144613A1 (en) 2021-01-14
AU2020309223A1 (en) 2022-03-03
BR112022000117A2 (pt) 2022-02-15

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