DK2986281T3 - Oral formulering til behandling af kardiovaskulære sygdomme - Google Patents

Oral formulering til behandling af kardiovaskulære sygdomme Download PDF

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Publication number
DK2986281T3
DK2986281T3 DK14728940.9T DK14728940T DK2986281T3 DK 2986281 T3 DK2986281 T3 DK 2986281T3 DK 14728940 T DK14728940 T DK 14728940T DK 2986281 T3 DK2986281 T3 DK 2986281T3
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DK
Denmark
Prior art keywords
dosage form
coating
use according
pharmaceutical dosage
acetylsalicylic acid
Prior art date
Application number
DK14728940.9T
Other languages
English (en)
Inventor
Hurtado Javier Urbano
Sanz Pablo Martin
Original Assignee
Ferrer Int
Fundación Centro Nac De Investig Cardiovasculares Carlos Iii (Cnic)
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Application filed by Ferrer Int, Fundación Centro Nac De Investig Cardiovasculares Carlos Iii (Cnic) filed Critical Ferrer Int
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Publication of DK2986281T3 publication Critical patent/DK2986281T3/da

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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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • A61K9/2009—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
    • A61K9/20—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • 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
    • A61P9/02—Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (11)

1. Oralt administrerbar farmaceutisk doseringsform til anvendelse i forebyggelse og/eller behandling afen kardiovaskulær sygdom, hvilken doseringsform omfatter: (a) acetylsalicylsyre som et første aktivt middel og (b) HMG-CoA-reduktasehæmmer som et andet aktivt middel, hvor HMG-CoA-reduktasehæmmeren er udvalgt fra atorvastatin og rosuvastatin og salte deraf, og hvor (a) er to eller flere enkeltstående separate belagte doseringsenheder omfattende én eller flere vandopløselige polymere i belægningen, og hvor belægningen i alt væsentligt er fri for en vandopløselig polymer eller en enterisk polymer, hvilket vil sige i en mængde i intervallet mellem 0 til 5 vægt-% af belægningens sammensætning; og hvor mængden af belægning ligger fra 8 til 12 mg/cm2; og som udviser en ikke-modificeret frigørelsesprofil; og (b) er én eller flere enkeltstående separate belagte doseringsenheder; doseringsenhederne er i form af tabletter, og den vandopløselige polymer er til stede i en mængde efter vægt på over 40 % af belægningens totale vægt og er udvalgt fra gruppen bestående af et vandopløseligt polyvinylderivat udvalgt fra polyvinylpyrrolidon, delvis hydrolyseret polyvinylalkohol, polyvinylalkohol og blandinger deraf.
2. Farmaceutisk doseringsform til anvendelse ifølge krav 1, hvor doseringsformen er i form af en kapsel.
3. Farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den vandopløselige polymer er udvalgt fra gruppen bestående af delvis hydrolyseret polyvinylalkohol, polyvinylalkohol og blandinger deraf.
4. Farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor acetylsalicylsyredoseringsenheder (a) udviser en procentdel lig med eller større end 65 %, fortrinsvis større end 75 %, mere fortrinsvis større end 80 % og endnu mere fortrinsvis større end 85 % acetylsalicylsyre opløst i 60 minutter, fortrinsvis i 30 minutter og mere fortrinsvis i 15 minutter i et apparat af type 1 ifølge den amerikanske farmakopé i 0,05 M acetatbuffer, ved pH 4,5, 100 o/m i et volumen på 900 ml.
5. Farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor (a) og (b) doseringsenheder er i form af belagte tabletter.
6. Farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor mængden af acetylsalicylsyre i doseringsformen ligger i intervallet 10 til 400 mg pr. doseringsenhed.
7. Farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor mængden af HMG-CoA-reduktasehæmmer i doseringsformen ligger i intervallet 5 til 40 mg pr. doseringsenhed.
8. Farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor HMG-CoA-reduktasehæmmeren er i form af to eller flere doseringsenheder.
9. Farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvilken doseringsform endvidere omfatter én eller flere enkeltstående separate doseringsenheder omfattende en hæmmer af rennin-angiotensin-systemet som et tredje aktivt middel.
10. Farmaceutisk doseringsform til anvendelse ifølge det foregående krav, hvor hæmmeren af rennin-angiotensin-systemet er en ACE-hæmmer udvalgt fra gruppen bestående af ramipril, captopril, cilazapril, delapril, enalapril, fentiapril, fosinopril, indolapril, lisinopril, perindopril, pivopril, quinapril, spirapril, trandolapril og zofenopril og farmaceutisk acceptable salte eller en angiotensin-receptorblokker udvalgt fra gruppen bestående af losartan, valsartan, irbesartan, candesartan, telmisartan, eprosartan, tasosartan, zolarsartan, azilsartan, olmesartan, saprisartan, forasartan, E-4177 og ZD-8731 og farmaceutisk acceptable salte.
11. Farmaceutisk doseringsform til anvendelse ifølge det foregående krav, hvor ACE-hæmmeren er ramipril og farmaceutisk acceptable salte.
DK14728940.9T 2013-06-06 2014-06-05 Oral formulering til behandling af kardiovaskulære sygdomme DK2986281T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13170909.9A EP2810644A1 (en) 2013-06-06 2013-06-06 Oral formulation for the treatment of cardiovascular diseases
PCT/EP2014/061735 WO2014195421A1 (en) 2013-06-06 2014-06-05 Oral formulation for the treatment of cardiovascular diseases

Publications (1)

Publication Number Publication Date
DK2986281T3 true DK2986281T3 (da) 2017-04-03

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ID=48569993

Family Applications (1)

Application Number Title Priority Date Filing Date
DK14728940.9T DK2986281T3 (da) 2013-06-06 2014-06-05 Oral formulering til behandling af kardiovaskulære sygdomme

Country Status (42)

Country Link
US (1) US10617699B2 (da)
EP (3) EP2810644A1 (da)
JP (1) JP6151854B2 (da)
KR (1) KR101839665B1 (da)
CN (2) CN104224804A (da)
AP (1) AP2015008882A0 (da)
AR (1) AR096350A1 (da)
AU (1) AU2014276883B2 (da)
BR (1) BR112015030350B1 (da)
CA (1) CA2912350C (da)
CL (1) CL2015003561A1 (da)
CR (1) CR20150635A (da)
CU (1) CU24326B1 (da)
CY (1) CY1118766T1 (da)
DK (1) DK2986281T3 (da)
DO (1) DOP2015000296A (da)
EA (1) EA028969B1 (da)
EC (1) ECSP15050273A (da)
ES (1) ES2620078T3 (da)
GE (1) GEP201706743B (da)
HK (1) HK1204562A1 (da)
HU (1) HUE033458T2 (da)
IL (1) IL242569B (da)
MA (1) MA38699B1 (da)
MD (1) MD4475C1 (da)
MX (1) MX347801B (da)
MY (1) MY181272A (da)
NI (1) NI201500171A (da)
NZ (1) NZ714707A (da)
PE (1) PE20160051A1 (da)
PH (1) PH12015502706A1 (da)
PL (1) PL2986281T3 (da)
PT (1) PT2986281T (da)
RS (1) RS55786B1 (da)
SA (1) SA515370243B1 (da)
SG (1) SG11201509353QA (da)
SI (1) SI2986281T1 (da)
TN (1) TN2015000501A1 (da)
TW (1) TWI630928B (da)
UA (1) UA113806C2 (da)
WO (1) WO2014195421A1 (da)
ZA (1) ZA201508452B (da)

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CN111135149B (zh) * 2018-11-04 2021-05-11 张家港市中医医院 一种瑞舒伐他汀钙片及其制备方法
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PL4299063T3 (pl) 2022-06-30 2024-06-10 Ferrer Internacional, S.A. Kapsułki doustne zawierające tabletki atorwastatyny wykazujące odpowiedni profil rozpuszczania i biodostępność

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Also Published As

Publication number Publication date
KR101839665B1 (ko) 2018-03-16
ES2620078T3 (es) 2017-06-27
NZ714707A (en) 2019-04-26
CU20150173A7 (es) 2016-06-29
AR096350A1 (es) 2015-12-23
HK1204562A1 (en) 2015-11-27
CU24326B1 (es) 2018-03-13
ZA201508452B (en) 2017-02-22
SA515370243B1 (ar) 2016-09-19
PT2986281T (pt) 2017-03-29
MD4475B1 (ro) 2017-04-30
PH12015502706B1 (en) 2016-03-14
AU2014276883B2 (en) 2017-04-20
HUE033458T2 (en) 2017-12-28
CA2912350A1 (en) 2014-12-11
MX347801B (es) 2017-05-15
CY1118766T1 (el) 2017-07-12
EP2810644A1 (en) 2014-12-10
RS55786B1 (sr) 2017-07-31
MD20160001A2 (ro) 2016-05-31
TWI630928B (zh) 2018-08-01
KR20160014622A (ko) 2016-02-11
US10617699B2 (en) 2020-04-14
EP3175849A1 (en) 2017-06-07
AU2014276883A1 (en) 2015-11-26
CN113143888A (zh) 2021-07-23
BR112015030350B1 (pt) 2022-11-29
MA38699B1 (fr) 2017-09-29
ECSP15050273A (es) 2017-07-31
SG11201509353QA (en) 2015-12-30
DOP2015000296A (es) 2016-12-30
JP6151854B2 (ja) 2017-06-21
BR112015030350A2 (pt) 2017-07-25
MD4475C1 (ro) 2017-11-30
TN2015000501A1 (en) 2017-04-06
NI201500171A (es) 2019-05-07
PH12015502706A1 (en) 2016-03-14
MY181272A (en) 2020-12-21
JP2016520135A (ja) 2016-07-11
EP2986281A1 (en) 2016-02-24
MA38699A1 (fr) 2017-01-31
SI2986281T1 (sl) 2017-07-31
TW201536357A (zh) 2015-10-01
WO2014195421A1 (en) 2014-12-11
US20160106763A1 (en) 2016-04-21
GEP201706743B (en) 2017-09-25
EP2986281B1 (en) 2016-12-21
AP2015008882A0 (en) 2015-11-30
CN104224804A (zh) 2014-12-24
IL242569B (en) 2018-12-31
PL2986281T3 (pl) 2017-06-30
MX2015015753A (es) 2016-08-03
CR20150635A (es) 2016-06-10
EA201600012A1 (ru) 2016-07-29
EA028969B1 (ru) 2018-01-31
CA2912350C (en) 2017-04-04
UA113806C2 (xx) 2017-03-10
PE20160051A1 (es) 2016-01-25
CL2015003561A1 (es) 2016-06-10

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