CR20160293A - Formulación compuesta para administración oral que comprende ezetimibe y rosuvastatina - Google Patents

Formulación compuesta para administración oral que comprende ezetimibe y rosuvastatina

Info

Publication number
CR20160293A
CR20160293A CR20160293A CR20160293A CR20160293A CR 20160293 A CR20160293 A CR 20160293A CR 20160293 A CR20160293 A CR 20160293A CR 20160293 A CR20160293 A CR 20160293A CR 20160293 A CR20160293 A CR 20160293A
Authority
CR
Costa Rica
Prior art keywords
rosuvastatin
oral administration
ezetimibe
administration including
composite formulation
Prior art date
Application number
CR20160293A
Other languages
English (en)
Inventor
Yong Il Kim
Seung Jun Lee
Jae Hyun Park
Jin Cheul Kim
Jung Hyun Cho
Jong Soo Woo
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=CR20160293(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 CR20160293A publication Critical patent/CR20160293A/es

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • 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
    • 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
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered 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
    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Se proporciona una formulacion compuesta solida para administracion oral, incluyendo la formulacion compuesta solida: una parte de granulos de ezetimibe, que incluye ezetimibe, teniendo dicho ezetimibe una distribucion de tamanos de particulas en la que el tamano medio de particulas 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 farmaceuticamente aceptable de la misma, y un metodo para preparar la formulacion compuesta.
CR20160293A 2013-12-30 2014-12-30 Formulación compuesta para administración oral que comprende ezetimibe y rosuvastatina CR20160293A (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
CR20160293A true CR20160293A (es) 2016-10-05

Family

ID=53791740

Family Applications (1)

Application Number Title Priority Date Filing Date
CR20160293A CR20160293A (es) 2013-12-30 2014-12-30 Formulación compuesta para administración 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) PH12016501196A1 (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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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
CZ2016539A3 (cs) * 2016-09-05 2018-03-14 Zentiva, K.S. Farmaceutická kompozice obsahující dvě rozdílné účinné látky a způsob její přípravy
CZ2016538A3 (cs) 2016-09-05 2018-03-14 Zentiva, K.S. Farmaceutická kompozice obsahující dvě rozdílné účinné látky
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
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JP2022104836A (ja) * 2020-12-29 2022-07-11 日本ジェネリック株式会社 エゼチミブ及びロスバスタチンを含む錠剤
CN112999178A (zh) * 2021-03-01 2021-06-22 乐普制药科技有限公司 一种依折麦布匹伐他汀钙复方双层片剂
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Also Published As

Publication number Publication date
NI201600093A (es) 2016-07-22
MY187637A (en) 2021-10-05
UA117685C2 (uk) 2018-09-10
AU2014374552B2 (en) 2019-09-19
DOP2016000159A (es) 2016-12-15
PE20161072A1 (es) 2016-11-04
PH12016501196B1 (en) 2016-08-15
ZA201603934B (en) 2017-09-27
TW201609091A (zh) 2016-03-16
CA2933178A1 (en) 2015-07-09
EP3089739A1 (en) 2016-11-09
WO2015102400A1 (en) 2015-07-09
AR098996A1 (es) 2016-06-22
AU2014374552A1 (en) 2016-06-02
TWI655944B (zh) 2019-04-11
CL2016001654A1 (es) 2017-01-06
UY35932A (es) 2015-07-31
KR20150079454A (ko) 2015-07-08
EP3089739A4 (en) 2017-08-02
US10434067B2 (en) 2019-10-08
GT201600137A (es) 2018-10-19
CN105873571A (zh) 2016-08-17
JP2017500303A (ja) 2017-01-05
RU2683937C2 (ru) 2019-04-03
KR20150079373A (ko) 2015-07-08
RU2016123828A (ru) 2018-02-07
RU2016123828A3 (es) 2018-08-28
SG10201805657PA (en) 2018-08-30
MX2016008725A (es) 2017-02-28
PH12016501196A1 (en) 2016-08-15
SV2016005236A (es) 2016-11-03
CN105873571B (zh) 2019-10-22
US20160346213A1 (en) 2016-12-01

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