DK2830618T3 - Farmaceutisk sammensætning omfattende olmesartan-medoxomil og rosuvastatin eller dettes salt - Google Patents

Farmaceutisk sammensætning omfattende olmesartan-medoxomil og rosuvastatin eller dettes salt Download PDF

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Publication number
DK2830618T3
DK2830618T3 DK13769567.2T DK13769567T DK2830618T3 DK 2830618 T3 DK2830618 T3 DK 2830618T3 DK 13769567 T DK13769567 T DK 13769567T DK 2830618 T3 DK2830618 T3 DK 2830618T3
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olmesartan medoxomil
rosuvastatin
weight
pharmaceutical composition
segment
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DK13769567.2T
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English (en)
Inventor
Hee-Chul Chang
Bok-Ki Kang
Jun-Ku Kim
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Dae Woong Pharma
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    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/2086—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
    • A61K9/20—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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

Claims (10)

1. Farmaceutisk sammensætning med en enkelt doseringsform omfattende et segment omfattende olmesartan-medoxomil; og et segment omfattende rosuvastatin eller dettes salt, hvor segmenterne er formulerede i en separat form, hvor segmentet, som omfatter olmesartan-medoxomil omfatter ét eller flere spræng-midler valgt fra gruppen bestående af lavsubstitueret hydroxypropylcellulose, carboxy-methylcellulosecalcium, croscarmellosenatrium, crospovidon, natriumstivelsesglycolat og prægelatiniseret stivelse, og hvor segmentet omfattende rosuvastatin eller dettes salt omfatter ét eller flere spræng-midler valgt fra gruppen bestående af crospovidon, lavsubstitueret hydroxypropylcellulose, croscarmellosenatrium, og carboxymethylcellulosecalcium.
2. Farmaceutisk sammensætning ifølge krav 1, med en dobbeltlags-tabletform, en tabletform bestående i det væsentlige af en indvendig kerne og et udvendigt lag, eller en granulat-indeholdende kapselform.
3. Farmaceutisk sammensætning ifølge krav 1, med en dobbeltlaget tabletform bestående i det væsentlige af et lag omfattende rosuvastatin eller dettes salt og et lag omfattende olmesartan-medoxomil.
4. Farmaceutisk sammensætning ifølge krav 1, med en tabletform bestående i det væsentlige af en indvendig kerne omfattende rosuvastatin eller dettes salt og et udvendigt lag omfattende olmesartan-medoxomil.
5. Farmaceutisk sammensætning ifølge krav 1, med en kapselform fyldt med granulat omfattende rosuvastatin eller dettes salt og granulat omfattende olmesartan-medoxomil.
6. Farmaceutisk sammensætning ifølge krav 1, hvor sprængmidlet i segmentet omfattende rosuvastatin eller dettes salt foreligger i en mængde liggende imellem 2 og 20 vægt%, baseret på den totale vægt af segmentet omfattende rosuvastatin eller dettes salt.
7. Farmaceutisk sammensætning ifølge krav 1, hvor segmentet omfattende olmesartan-medoxomil omfatter 7,5 eller flere vægt% af lavsubstitueret hydroxypropylcellulose, 5 eller flere vægt% af carboxymethylcellulosecalcium, 15 eller flere vægt% af cros-carmellosenatrium, 10 eller flere vægt% af crospovidon, 5 eller flere vægt% af natrium-stivelsesglycolat, eller 5 eller flere vægt% af prægelatiniseret stivelse, baseret på den totale vægt af segmentet omfattende olmesartan-medoxomil.
8. Farmaceutisk sammensætning ifølge krav 1, hvor segmentet omfattende olmesartan-medoxomil omfatter 7,5 til 65 vægt% af lavsubstitueret hydroxypropylcellulose, 5 til 60 vægt% af carboxymethylcellulosecalcium, 15 til 30 vægt% af croscarmellosenatrium, 10 til 40 vægt% af crospovidon, 5 til 40 vægt% af natriumstivelsesglycolat, eller 5 til 60 vægt% af prægelatiniseret stivelse, baseret på den totale vægt af segmentet omfattende olmesartan-medoxomil.
9. Farmaceutisk sammensætning ifølge krav 1, hvor segmentet omfattende olmesartan-medoxomil omfatter 7,5 til 65 vægt% af lavsubstitueret hydroxypropylcellulose, baseret på den totale vægt af segmentet omfattende olmesartan-medoxomil.
10. Farmaceutisk sammensætning ifølge krav 1, hvor segmentet omfattende olmesartan-medoxomil omfatter 10 til 60 vægt% af lavsubstitueret hydroxypropylcellulose, baseret på den totale vægt af segmentet omfattende olmesartan-medoxomil.
DK13769567.2T 2012-03-30 2013-03-22 Farmaceutisk sammensætning omfattende olmesartan-medoxomil og rosuvastatin eller dettes salt DK2830618T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20120032903 2012-03-30
PCT/KR2013/002378 WO2013147462A1 (en) 2012-03-30 2013-03-22 Pharmaceutical composition comprising olmesartan medoxomil and rosuvastatin or its salt

Publications (1)

Publication Number Publication Date
DK2830618T3 true DK2830618T3 (da) 2016-10-03

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Country Link
US (1) US20150050333A1 (da)
EP (1) EP2830618B1 (da)
JP (1) JP6122098B2 (da)
KR (2) KR101451081B1 (da)
CN (1) CN104220068B (da)
AU (1) AU2013240846B2 (da)
CA (1) CA2866377C (da)
CL (1) CL2014002581A1 (da)
CY (1) CY1117909T1 (da)
DK (1) DK2830618T3 (da)
ES (1) ES2587912T3 (da)
HK (1) HK1200107A1 (da)
HU (1) HUE030674T2 (da)
IN (1) IN2014MN01919A (da)
LT (1) LT2830618T (da)
MX (1) MX362400B (da)
MY (1) MY166288A (da)
PH (2) PH12014501813B1 (da)
PT (1) PT2830618T (da)
RU (1) RU2616516C2 (da)
SG (2) SG10201502582PA (da)
WO (1) WO2013147462A1 (da)
ZA (1) ZA201407544B (da)

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Also Published As

Publication number Publication date
CA2866377C (en) 2020-02-11
WO2013147462A1 (en) 2013-10-03
EP2830618A1 (en) 2015-02-04
CY1117909T1 (el) 2017-05-17
ES2587912T3 (es) 2016-10-27
AU2013240846B2 (en) 2017-02-02
HK1200107A1 (en) 2015-07-31
RU2616516C2 (ru) 2017-04-17
AU2013240846A1 (en) 2014-08-28
JP2015511635A (ja) 2015-04-20
EP2830618A4 (en) 2015-08-05
EP2830618B1 (en) 2016-07-27
HUE030674T2 (en) 2017-06-28
MX362400B (es) 2019-01-16
MX2014011510A (es) 2014-12-05
PT2830618T (pt) 2016-11-04
CA2866377A1 (en) 2013-10-03
RU2014143536A (ru) 2016-05-27
CN104220068A (zh) 2014-12-17
PH12016500420A1 (en) 2017-04-10
JP6122098B2 (ja) 2017-04-26
ZA201407544B (en) 2015-12-23
SG10201502582PA (en) 2015-05-28
MY166288A (en) 2018-06-25
CL2014002581A1 (es) 2015-01-09
PH12014501813A1 (en) 2014-11-24
KR101451081B1 (ko) 2014-10-16
KR20140085411A (ko) 2014-07-07
US20150050333A1 (en) 2015-02-19
LT2830618T (lt) 2016-09-26
KR20130111335A (ko) 2013-10-10
KR101931195B1 (ko) 2018-12-21
CN104220068B (zh) 2017-08-04
PH12014501813B1 (en) 2014-11-24
IN2014MN01919A (da) 2015-07-10
SG11201405198YA (en) 2014-09-26

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