ECSP19037610A - Comprimido compuesto oral que comprende ezetimiba y rosuvastatina - Google Patents

Comprimido compuesto oral que comprende ezetimiba y rosuvastatina

Info

Publication number
ECSP19037610A
ECSP19037610A ECSENADI201937610A ECDI201937610A ECSP19037610A EC SP19037610 A ECSP19037610 A EC SP19037610A EC SENADI201937610 A ECSENADI201937610 A EC SENADI201937610A EC DI201937610 A ECDI201937610 A EC DI201937610A EC SP19037610 A ECSP19037610 A EC SP19037610A
Authority
EC
Ecuador
Prior art keywords
rosuvastatin
diluent
water
ezetimibe
ezetimiba
Prior art date
Application number
ECSENADI201937610A
Other languages
English (en)
Inventor
Han Byul Song
Jong Soo Woo
Jae Hyun Park
Yong Il Kim
Jin Cheul Kim
Jung Hyun Cho
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 ECSP19037610A publication Critical patent/ECSP19037610A/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
    • A61K9/2072—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
    • 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
    • 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
    • A61K9/20—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
    • A61K9/2072—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
    • 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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Se proporcionan un comprimido compuesto oral y un método para prepararlo. El comprimido compuesto oral incluye: una porción de gránulos húmedos de ezetimiba que incluye ezetimiba; y una porción de mezcla de rosuvastatina que incluye rosuvastatina o una de sus sales farmacéuticamente aceptables, donde la porción de gránulos húmedos de ezetimiba incluye, a modo de aglutinante, povidona que tiene un peso molecular promedio ponderado de aproximadamente 30 000 a aproximadamente 50 000, y la porción de mezcla de rosuvastatina incluye un diluyente, que incluye un diluyente hidrosoluble y un diluyente no hidrosoluble, teniendo el diluyente no hidrosoluble un tamaño de partícula (d90) de aproximadamente 98 um a aproximadamente 229 um correspondiente a un 90% en una distribución de tamaños de partícula acumulativa de las partículas totales.
ECSENADI201937610A 2016-11-29 2019-05-28 Comprimido compuesto oral que comprende ezetimiba y rosuvastatina ECSP19037610A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020160160513A KR102206535B1 (ko) 2016-11-29 2016-11-29 에제티미브 및 로수바스타틴을 포함하는 경구용 복합정제

Publications (1)

Publication Number Publication Date
ECSP19037610A true ECSP19037610A (es) 2019-06-30

Family

ID=62241643

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSENADI201937610A ECSP19037610A (es) 2016-11-29 2019-05-28 Comprimido compuesto oral que comprende ezetimiba y rosuvastatina

Country Status (8)

Country Link
KR (1) KR102206535B1 (es)
BR (1) BR112019010706A2 (es)
CL (1) CL2019001424A1 (es)
EC (1) ECSP19037610A (es)
MX (1) MX2019006148A (es)
MY (1) MY197281A (es)
SG (1) SG11201903261VA (es)
WO (1) WO2018101681A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021019499A1 (en) 2019-07-31 2021-02-04 TECNIMEDE - Sociedade Técnico-medicinal, SA Solid oral multiple-unit immediate release compositions, methods and uses thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009024889A2 (en) 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
DK2844233T3 (da) 2012-05-01 2020-07-13 Althera Life Sciences Llc Oral tabletformulering bestående af en fastsat kombination af rosuvastatin og ezetimib til behandling af hyperlipidæmi og kardiovaskulære sygdomme
KR20150079373A (ko) * 2013-12-30 2015-07-08 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제
KR101977785B1 (ko) * 2014-06-25 2019-05-14 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 및 그 제조방법
KR101834559B1 (ko) * 2015-02-27 2018-03-06 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 고형 복합제제

Also Published As

Publication number Publication date
MY197281A (en) 2023-06-09
KR20180060705A (ko) 2018-06-07
WO2018101681A1 (en) 2018-06-07
KR102206535B1 (ko) 2021-01-22
SG11201903261VA (en) 2019-05-30
CL2019001424A1 (es) 2019-10-04
MX2019006148A (es) 2019-08-14
BR112019010706A2 (pt) 2019-10-01

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