MX2021012568A - Preparacion de combinacion farmaceutica que comprende ezetimiba y losartan. - Google Patents

Preparacion de combinacion farmaceutica que comprende ezetimiba y losartan.

Info

Publication number
MX2021012568A
MX2021012568A MX2021012568A MX2021012568A MX2021012568A MX 2021012568 A MX2021012568 A MX 2021012568A MX 2021012568 A MX2021012568 A MX 2021012568A MX 2021012568 A MX2021012568 A MX 2021012568A MX 2021012568 A MX2021012568 A MX 2021012568A
Authority
MX
Mexico
Prior art keywords
ezetimibe
losartan
pharmaceutical combination
combination preparation
dissolved
Prior art date
Application number
MX2021012568A
Other languages
English (en)
Inventor
Yong Il Kim
Ho Taek Im
Hyuk Jun Cho
Min Wook Kim
Original Assignee
Hanmi Pharm Ind Co Ltd
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 Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of MX2021012568A publication Critical patent/MX2021012568A/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
    • A61K9/20Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K31/397Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • A61K31/41641,3-Diazoles
    • A61K31/41781,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se refiere a una preparación de combinación farmacéutica que comprende ezetimiba y losartán. Cuando la preparación de combinación farmacéutica se disuelve en una solución de pH 4.0 a 5.0 durante 10 minutos, la cantidad disuelta de losartán es 5,700 µg o menos, y la cantidad disuelta de ezetimiba es 270 µg o más. La disolución en una solución de pH 4.0 a 5.0 se lleva a cabo en las condiciones de una temperatura de 37°C y un método de paletas de 50 rpm en 500 mL de regulador de pH de acetato de conformidad con la Farmacopea de Estados Unidos para la preparación de combinación farmacéutica que comprende 20 mg de ezetimiba y 183 mg de losartán.
MX2021012568A 2019-04-18 2020-04-07 Preparacion de combinacion farmaceutica que comprende ezetimiba y losartan. MX2021012568A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020190045295A KR102500643B1 (ko) 2019-04-18 2019-04-18 에제티미브 및 로사르탄을 포함하는 약제학적 복합제제
PCT/KR2020/004694 WO2020213868A1 (ko) 2019-04-18 2020-04-07 에제티미브 및 로사르탄을 포함하는 약제학적 복합제제

Publications (1)

Publication Number Publication Date
MX2021012568A true MX2021012568A (es) 2021-11-12

Family

ID=72838309

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021012568A MX2021012568A (es) 2019-04-18 2020-04-07 Preparacion de combinacion farmaceutica que comprende ezetimiba y losartan.

Country Status (8)

Country Link
EP (1) EP3957303A4 (es)
KR (1) KR102500643B1 (es)
CN (1) CN113747885B (es)
MX (1) MX2021012568A (es)
SG (1) SG11202111410SA (es)
TW (1) TWI827828B (es)
WO (1) WO2020213868A1 (es)
ZA (1) ZA202108268B (es)

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5138069A (en) 1986-07-11 1992-08-11 E. I. Du Pont De Nemours And Company Angiotensin II receptor blocking imidazoles
CA2179067A1 (en) 1993-12-23 1995-06-29 Gordon Creston Campbell, Jr. Polymorphs of losartan and the process for the preparation of form ii of losartan
CN101594850A (zh) * 2006-12-21 2009-12-02 兰贝克赛实验室有限公司 降血脂药物组合物和及其制备方法
WO2008095263A1 (en) * 2007-02-09 2008-08-14 Alphapharm Pty Ltd A dosage form containing two or more active pharmaceutical ingredients in different physical forms
WO2009024889A2 (en) * 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
EP2844233B1 (en) * 2012-05-01 2020-05-06 Althera Life Sciences, LLC Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
KR101910901B1 (ko) * 2013-11-29 2018-10-24 한미약품 주식회사 암로디핀, 로자탄 및 로수바스타틴을 포함하는 약제학적 복합 제제
KR101977785B1 (ko) * 2014-06-25 2019-05-14 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 및 그 제조방법
RU2724338C2 (ru) * 2015-06-30 2020-06-23 Ханми Фарм. Ко., Лтд. Фармацевтическая комплексная композиция, включающая амлодипин, лозартан и розувастатин
CN106237334B (zh) * 2016-07-29 2019-05-24 珠海赛隆药业股份有限公司(长沙)医药研发中心 一种血管紧张素受体拮抗剂和米力农的复合物及其用途
EP3509603B1 (en) 2016-09-07 2024-01-03 Alyssum Therapeutics, Inc. Immune memory induction by platinum based compounds
KR102569271B1 (ko) * 2018-03-19 2023-08-23 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 약제학적 복합제제

Also Published As

Publication number Publication date
SG11202111410SA (en) 2021-11-29
CN113747885B (zh) 2023-08-15
KR102500643B1 (ko) 2023-02-16
TW202103697A (zh) 2021-02-01
ZA202108268B (en) 2023-07-26
EP3957303A4 (en) 2022-11-23
TWI827828B (zh) 2024-01-01
CN113747885A (zh) 2021-12-03
EP3957303A1 (en) 2022-02-23
KR20200122517A (ko) 2020-10-28
WO2020213868A1 (ko) 2020-10-22

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