DOP2016000159A - 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
DOP2016000159A
DOP2016000159A DO2016000159A DO2016000159A DOP2016000159A DO P2016000159 A DOP2016000159 A DO P2016000159A DO 2016000159 A DO2016000159 A DO 2016000159A DO 2016000159 A DO2016000159 A DO 2016000159A DO P2016000159 A DOP2016000159 A DO P2016000159A
Authority
DO
Dominican Republic
Prior art keywords
rosuvastatin
ezetimibe
oral administration
composite formulation
formulation
Prior art date
Application number
DO2016000159A
Other languages
English (en)
Inventor
Jae Hyun Park
Jong Soo Woo
Jung Hyun Cho
Jin Cheul Kim
Yong Ii Kim
Seung Jun Lee
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=DOP2016000159(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 DOP2016000159A publication Critical patent/DOP2016000159A/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; 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
    • 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)
  • 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.
DO2016000159A 2013-12-30 2016-06-24 Formulación compuesta para administración oral que comprende ezetimibe y rosuvastatina. DOP2016000159A (es)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
DOP2016000159A true DOP2016000159A (es) 2016-12-15

Family

ID=53791740

Family Applications (1)

Application Number Title Priority Date Filing Date
DO2016000159A DOP2016000159A (es) 2013-12-30 2016-06-24 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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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
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GR1009727B (el) * 2018-11-28 2020-04-14 Elpen Αε Φαρμακευτικη Βιομηχανια Μονολιθικη σταθερη φαρμακοτεχνικη μορφη ταχειας αποδεσμευσης εζετιμιμπης και ροσουβαστατινης
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Also Published As

Publication number Publication date
CN105873571A (zh) 2016-08-17
CL2016001654A1 (es) 2017-01-06
AR098996A1 (es) 2016-06-22
SG10201805657PA (en) 2018-08-30
ZA201603934B (en) 2017-09-27
KR20150079454A (ko) 2015-07-08
PH12016501196B1 (en) 2016-08-15
SV2016005236A (es) 2016-11-03
EP3089739A1 (en) 2016-11-09
TWI655944B (zh) 2019-04-11
RU2016123828A (ru) 2018-02-07
CN105873571B (zh) 2019-10-22
CR20160293A (es) 2016-10-05
UA117685C2 (uk) 2018-09-10
KR20150079373A (ko) 2015-07-08
UY35932A (es) 2015-07-31
MY187637A (en) 2021-10-05
RU2683937C2 (ru) 2019-04-03
US10434067B2 (en) 2019-10-08
GT201600137A (es) 2018-10-19
PE20161072A1 (es) 2016-11-04
EP3089739A4 (en) 2017-08-02
TW201609091A (zh) 2016-03-16
AU2014374552A1 (en) 2016-06-02
MX2016008725A (es) 2017-02-28
CA2933178A1 (en) 2015-07-09
WO2015102400A1 (en) 2015-07-09
NI201600093A (es) 2016-07-22
AU2014374552B2 (en) 2019-09-19
PH12016501196A1 (en) 2016-08-15
US20160346213A1 (en) 2016-12-01
JP2017500303A (ja) 2017-01-05
RU2016123828A3 (es) 2018-08-28

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