CL2019001424A1 - Oral compound tablet comprising ezetimibe and rosuvastatin. - Google Patents

Oral compound tablet comprising ezetimibe and rosuvastatin.

Info

Publication number
CL2019001424A1
CL2019001424A1 CL2019001424A CL2019001424A CL2019001424A1 CL 2019001424 A1 CL2019001424 A1 CL 2019001424A1 CL 2019001424 A CL2019001424 A CL 2019001424A CL 2019001424 A CL2019001424 A CL 2019001424A CL 2019001424 A1 CL2019001424 A1 CL 2019001424A1
Authority
CL
Chile
Prior art keywords
rosuvastatin
ezetimiba
water
thinner
ezetimibe
Prior art date
Application number
CL2019001424A
Other languages
Spanish (es)
Inventor
Han Byul Song
Jung Hyun Cho
Jin Cheul Kim
Youg Il Kim
Jae Hyun Park
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
Application filed by Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of CL2019001424A1 publication Critical patent/CL2019001424A1/en

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

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 ΜM A APROXIMADAMENTE 229 ΜM CORRESPONDIENTE A UN 90% EN UNA DISTRIBUCIÓN DE TAMAÑOS DE PARTÍCULA ACUMULATIVA DE LAS PARTÍCULAS TOTALES.AN ORAL COMPOUND TABLET AND A METHOD FOR PREPARING IT ARE PROVIDED. THE ORAL COMPOSITE TABLET INCLUDES: A SERVING OF EZETIMIBA WET GRANULES INCLUDING EZETIMIBA; AND A PORTION OF ROSUVASTATIN MIXTURE INCLUDING ROSUVASTATIN OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE SALTS, WHERE THE PORTION OF WET GRANULES OF EZETIMIBA INCLUDES, AS A BINDER, POVIDONE HAS ABOUT 50 AVERAGE-TO-HALF. AND THE ROSUVASTATIN MIXTURE PORTION INCLUDES ONE THINNER, INCLUDING A WATER-SOLUBLE THINNER AND A NON-WATER-SOLUBLE THINNER, WITH THE NON-WATER-SOLUBLE THINNER HAVING A PARTICLE SIZE (ABOUT 22 90) OF ABOUT 22 D90%. OF CUMULATIVE PARTICLE SIZES OF TOTAL PARTICLES.

CL2019001424A 2016-11-29 2019-05-27 Oral compound tablet comprising ezetimibe and rosuvastatin. CL2019001424A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020160160513A KR102206535B1 (en) 2016-11-29 2016-11-29 Oral composite tablet comprising ezetimibe and rosuvastatin

Publications (1)

Publication Number Publication Date
CL2019001424A1 true CL2019001424A1 (en) 2019-10-04

Family

ID=62241643

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2019001424A CL2019001424A1 (en) 2016-11-29 2019-05-27 Oral compound tablet comprising ezetimibe and rosuvastatin.

Country Status (8)

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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112022001783A2 (en) 2019-07-31 2022-03-22 Tecnimede Soc Tecnico Medicinal Sa Immediate release multi-unit solid oral compositions, their methods and uses.

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
WO2013166117A1 (en) 2012-05-01 2013-11-07 Althera Life Sciences, Llc Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
KR20150079373A (en) * 2013-12-30 2015-07-08 한미약품 주식회사 Composite formulation for oral administration comprising ezetimibe and rosuvastatin
KR101977785B1 (en) * 2014-06-25 2019-05-14 한미약품 주식회사 Composite formulation for oral administration comprising ezetimibe and rosuvastatin and a process for the preparation thereof
KR101834559B1 (en) * 2015-02-27 2018-03-06 한미약품 주식회사 Solid composite formulation for oral administration comprising ezetimibe and rosuvastatin

Also Published As

Publication number Publication date
KR20180060705A (en) 2018-06-07
ECSP19037610A (en) 2019-06-30
WO2018101681A1 (en) 2018-06-07
BR112019010706A2 (en) 2019-10-01
MX2019006148A (en) 2019-08-14
SG11201903261VA (en) 2019-05-30
KR102206535B1 (en) 2021-01-22
MY197281A (en) 2023-06-09

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