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MX2016008725A - Formulacion compuesta para administracion oral que comprende ezetimibe y rosuvastatina. - Google Patents

Formulacion compuesta para administracion oral que comprende ezetimibe y rosuvastatina.

Info

Publication number
MX2016008725A
MX2016008725A MX2016008725A MX2016008725A MX2016008725A MX 2016008725 A MX2016008725 A MX 2016008725A MX 2016008725 A MX2016008725 A MX 2016008725A MX 2016008725 A MX2016008725 A MX 2016008725A MX 2016008725 A MX2016008725 A MX 2016008725A
Authority
MX
Mexico
Prior art keywords
ezetimibe
rosuvastatin
composite formulation
oral administration
particle size
Prior art date
Application number
MX2016008725A
Other languages
English (en)
Inventor
Hyun Park Jae
Soo Woo Jong
Ii Kim Yong
Hyun Cho Jung
Cheul Kim Jin
Jun Lee Seung
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=53791740&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2016008725(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of MX2016008725A publication Critical patent/MX2016008725A/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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • 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
    • A61K31/495Heterocyclic 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
    • 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
    • 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
    • A61K9/2072Pills, 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
    • 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
    • A61K9/2095Tabletting 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
    • 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
    • A61K9/4833Encapsulating processes; Filling of capsules
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Se proporciona una formulación compuesta sólida para administración oral, incluyendo la formulación compuesta sólida: una parte de gránulos de ezetimibe, que incluye ezetimibe, teniendo dicho ezetimibe una distribución de tamaños de partículas en la que el tamaño medio de partículas d(0.9) para el 90% inferior es alrededor de 10 µm o menos; y una parte de mezcla de rosuvastatina, que incluye rosuvastatina o una sal farmacéuticamente aceptable de la misma, y un método para preparar la formulación compuesta.
MX2016008725A 2013-12-30 2014-12-30 Formulacion compuesta para administracion oral que comprende ezetimibe y rosuvastatina. MX2016008725A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20130167156 2013-12-30
KR1020140071081A KR20150079373A (ko) 2013-12-30 2014-06-11 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제
PCT/KR2014/013087 WO2015102400A1 (en) 2013-12-30 2014-12-30 Composite formulation for oral administration comprising ezetimibe and rosuvastatin

Publications (1)

Publication Number Publication Date
MX2016008725A true MX2016008725A (es) 2017-02-28

Family

ID=53791740

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016008725A MX2016008725A (es) 2013-12-30 2014-12-30 Formulacion compuesta para administracion oral que comprende ezetimibe y rosuvastatina.

Country Status (25)

Country Link
US (1) US10434067B2 (es)
EP (1) EP3089739A4 (es)
JP (1) JP2017500303A (es)
KR (2) KR20150079373A (es)
CN (1) CN105873571B (es)
AR (1) AR098996A1 (es)
AU (1) AU2014374552B2 (es)
CA (1) CA2933178A1 (es)
CL (1) CL2016001654A1 (es)
CR (1) CR20160293A (es)
DO (1) DOP2016000159A (es)
GT (1) GT201600137A (es)
MX (1) MX2016008725A (es)
MY (1) MY187637A (es)
NI (1) NI201600093A (es)
PE (1) PE20161072A1 (es)
PH (1) PH12016501196B1 (es)
RU (1) RU2683937C2 (es)
SG (1) SG10201805657PA (es)
SV (1) SV2016005236A (es)
TW (1) TWI655944B (es)
UA (1) UA117685C2 (es)
UY (1) UY35932A (es)
WO (1) WO2015102400A1 (es)
ZA (1) ZA201603934B (es)

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MX390899B (es) 2015-10-30 2025-03-21 Cancer Prevention Pharmaceuticals Inc Formulación de combinación de dosis fija, eflornitina y sulindaco.
EP3243506A1 (en) 2016-05-09 2017-11-15 Adamed sp. z o.o. Pharmaceutical composition
JP2017210455A (ja) * 2016-05-27 2017-11-30 ニプロ株式会社 エゼチミブ含有医薬組成物
CZ2016538A3 (cs) 2016-09-05 2018-03-14 Zentiva, K.S. Farmaceutická kompozice obsahující dvě rozdílné účinné látky
CZ2016539A3 (cs) * 2016-09-05 2018-03-14 Zentiva, K.S. Farmaceutická kompozice obsahující dvě rozdílné účinné látky a způsob její přípravy
KR101910902B1 (ko) * 2016-11-03 2018-10-24 한미약품 주식회사 암로디핀, 로자탄 및 클로르탈리돈을 포함하는 약제학적 복합제제
KR102206535B1 (ko) * 2016-11-29 2021-01-22 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 복합정제
JP6848469B2 (ja) * 2017-01-20 2021-03-24 ニプロ株式会社 エゼチミブ含有医薬組成物の製造方法
JP7115825B2 (ja) * 2017-06-28 2022-08-09 日医工株式会社 エゼチミブ含有経口製剤及びその製造方法
JP2019014700A (ja) * 2017-07-11 2019-01-31 大原薬品工業株式会社 エゼチミブ含有口腔内崩壊錠及びその製造方法
JP6937195B2 (ja) * 2017-09-01 2021-09-22 興和株式会社 医薬組成物
KR102569271B1 (ko) * 2018-03-19 2023-08-23 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 약제학적 복합제제
GR1009727B (el) * 2018-11-28 2020-04-14 Elpen Αε Φαρμακευτικη Βιομηχανια Μονολιθικη σταθερη φαρμακοτεχνικη μορφη ταχειας αποδεσμευσης εζετιμιμπης και ροσουβαστατινης
WO2021019499A1 (en) 2019-07-31 2021-02-04 TECNIMEDE - Sociedade Técnico-medicinal, SA Solid oral multiple-unit immediate release compositions, methods and uses thereof
TWI878600B (zh) * 2020-08-25 2025-04-01 南韓商大熊製藥股份有限公司 用於治療或預防高血壓及高膽固醇血症之單一劑型的醫藥組成物
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KR101335365B1 (ko) * 2012-05-22 2013-12-02 건일제약 주식회사 오메가-3 지방산 또는 그의 알킬 에스테르 및 스타틴계 약물을 함유하는 다층코팅 형태의 경구투여용 약학 조성물
MX2012014970A (es) * 2012-12-18 2013-08-27 Hetlabs Mexico S A De C V Composiciones farmaceuticas que comprenden ezetimiba y rosuvastatina de calcio amorfo novedoso.
KR102240429B1 (ko) * 2013-05-06 2021-04-15 한미약품 주식회사 로수바스타틴 또는 이의 약학적으로 허용되는 염이 함유된 필름 코팅층을 포함하는 복합 제형

Also Published As

Publication number Publication date
EP3089739A4 (en) 2017-08-02
AU2014374552B2 (en) 2019-09-19
KR20150079373A (ko) 2015-07-08
UY35932A (es) 2015-07-31
SV2016005236A (es) 2016-11-03
MY187637A (en) 2021-10-05
ZA201603934B (en) 2017-09-27
US20160346213A1 (en) 2016-12-01
PH12016501196A1 (en) 2016-08-15
NI201600093A (es) 2016-07-22
CN105873571A (zh) 2016-08-17
DOP2016000159A (es) 2016-12-15
JP2017500303A (ja) 2017-01-05
GT201600137A (es) 2018-10-19
WO2015102400A1 (en) 2015-07-09
CN105873571B (zh) 2019-10-22
UA117685C2 (uk) 2018-09-10
TW201609091A (zh) 2016-03-16
AR098996A1 (es) 2016-06-22
RU2683937C2 (ru) 2019-04-03
RU2016123828A3 (es) 2018-08-28
KR20150079454A (ko) 2015-07-08
US10434067B2 (en) 2019-10-08
CL2016001654A1 (es) 2017-01-06
PH12016501196B1 (en) 2016-08-15
CR20160293A (es) 2016-10-05
SG10201805657PA (en) 2018-08-30
CA2933178A1 (en) 2015-07-09
PE20161072A1 (es) 2016-11-04
RU2016123828A (ru) 2018-02-07
TWI655944B (zh) 2019-04-11
EP3089739A1 (en) 2016-11-09
AU2014374552A1 (en) 2016-06-02

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