CO2021017646A2 - Composiciones comprimidas de macitentán, métodos y usos de las mismas - Google Patents
Composiciones comprimidas de macitentán, métodos y usos de las mismasInfo
- Publication number
- CO2021017646A2 CO2021017646A2 CONC2021/0017646A CO2021017646A CO2021017646A2 CO 2021017646 A2 CO2021017646 A2 CO 2021017646A2 CO 2021017646 A CO2021017646 A CO 2021017646A CO 2021017646 A2 CO2021017646 A2 CO 2021017646A2
- Authority
- CO
- Colombia
- Prior art keywords
- macitentan
- compositions
- compressed
- present disclosure
- effective amount
- Prior art date
Links
Classifications
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K31/495—Heterocyclic 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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting 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
-
- 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
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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
La presente divulgación también se refiere a composiciones comprimidas que comprenden una cantidad terapéuticamente eficaz de macitentán, un diluyente de alcohol de azúcar y un tensioactivo. También se refiere al procedimiento de obtención de dichas composiciones comprimidas, a composiciones farmacéuticas orales que las comprenden, y a su uso en el tratamiento de hipertensión arterial pulmonar. La presente divulgación también se refiere a composiciones farmacéuticas orales sólidas que comprenden una cantidad terapéuticamente eficaz de macitentán que simultáneamente presentan propiedades de estabilidad mejoradas y perfiles de disolución adecuados, lo que presenta una necesidad insatisfecha en el campo de la formulación farmacéutica de macitentán.
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 |
---|---|
CO2021017646A2 true CO2021017646A2 (es) | 2022-01-17 |
Family
ID=71899791
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CONC2021/0017646A CO2021017646A2 (es) | 2019-07-05 | 2021-12-22 | Composiciones comprimidas de macitentán, métodos y usos de las mismas |
Country Status (11)
Country | Link |
---|---|
US (1) | US20220249381A1 (es) |
EP (1) | EP3993777B1 (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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2022258796A1 (en) * | 2021-06-11 | 2022-12-15 | Actelion Pharmaceuticals Ltd | Dispersible tablet for oral administration |
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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP4245130B2 (ja) | 2000-12-18 | 2009-03-25 | アクテリオン ファーマシューティカルズ リミテッド | 新規なスルファミド類 |
AU2006290309B2 (en) * | 2005-09-12 | 2012-04-05 | Actelion Pharmaceuticals Ltd. | Stable pharmaceutical composition comprising a pyrimidine-sulfamide |
PL2358374T3 (pl) | 2008-11-17 | 2014-03-31 | Takeda As | Ulepszona stabilność rozpuszczania tabletek węglanu wapnia |
DE14721256T1 (de) * | 2013-04-22 | 2017-03-16 | Sandoz Ag | Pharmazeutische zusammensetzungen mit kristallinem macitentan |
WO2014198178A1 (zh) * | 2013-06-14 | 2014-12-18 | 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 |
-
2020
- 2020-07-03 PE PE2021002203A patent/PE20220593A1/es unknown
- 2020-07-03 US US17/622,305 patent/US20220249381A1/en active Pending
- 2020-07-03 WO PCT/IB2020/056304 patent/WO2021005478A1/en unknown
- 2020-07-03 MX MX2022000267A patent/MX2022000267A/es unknown
- 2020-07-03 CA CA3144613A patent/CA3144613A1/en active Pending
- 2020-07-03 EP EP20750358.2A patent/EP3993777B1/en active Active
- 2020-07-03 BR BR112022000117A patent/BR112022000117A2/pt unknown
- 2020-07-03 AU AU2020309223A patent/AU2020309223A1/en active Pending
- 2020-07-03 CN CN202080049297.4A patent/CN114096239B/zh active Active
-
2021
- 2021-12-22 CO CONC2021/0017646A patent/CO2021017646A2/es unknown
-
2022
- 2022-01-03 CL CL2022000008A patent/CL2022000008A1/es unknown
Also Published As
Publication number | Publication date |
---|---|
EP3993777A1 (en) | 2022-05-11 |
CN114096239A (zh) | 2022-02-25 |
WO2021005478A1 (en) | 2021-01-14 |
CN114096239B (zh) | 2024-04-12 |
EP3993777B1 (en) | 2024-06-12 |
CL2022000008A1 (es) | 2022-10-07 |
CA3144613A1 (en) | 2021-01-14 |
BR112022000117A2 (pt) | 2022-02-15 |
MX2022000267A (es) | 2022-02-03 |
US20220249381A1 (en) | 2022-08-11 |
AU2020309223A1 (en) | 2022-03-03 |
PE20220593A1 (es) | 2022-04-22 |
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