AR097193A1 - Comprimidos farmacéuticos que comprenden ácido acetilsalicílico y clopidogrel - Google Patents

Comprimidos farmacéuticos que comprenden ácido acetilsalicílico y clopidogrel

Info

Publication number
AR097193A1
AR097193A1 ARP140102898A ARP140102898A AR097193A1 AR 097193 A1 AR097193 A1 AR 097193A1 AR P140102898 A ARP140102898 A AR P140102898A AR P140102898 A ARP140102898 A AR P140102898A AR 097193 A1 AR097193 A1 AR 097193A1
Authority
AR
Argentina
Prior art keywords
core
clopidogrel
gastro
pharmaceutically acceptable
acetylsalicylic acid
Prior art date
Application number
ARP140102898A
Other languages
English (en)
Original Assignee
Sanofi Sa
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=49085055&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR097193(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Sa filed Critical Sanofi Sa
Publication of AR097193A1 publication Critical patent/AR097193A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4365Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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

Landscapes

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

Abstract

Reivindicación 1: Un comprimido farmacéutico que comprende un núcleo y una capa externa, comprendiendo el núcleo ácido acetilsalicílico o una de sus sales farmacéuticamente aceptables y comprendiendo la capa externa clopidogrel o una de sus sales farmacéuticamente aceptables, estando separado el núcleo de la capa externa por un recubrimiento de tres capas compuesto de una capa gastrorresistente insertada entre dos capas aislantes, comprendiendo la capa gastrorresistente al menos un polímero gastrorresistente y al menos 40% en peso de talco, con respecto al peso del polímero gastrorresistente. Reivindicación 4: El comprimido según una cualquiera de las reivindicaciones precedentes, en el que la composición de las capas aislantes es idéntica y comprende hidroxipropilmetilcelulosa (HPMC), hidroxipropilcelulosa y/o alcohol polivinílico. Reivindicación 5: El comprimido según una cualquiera de las reivindicaciones precedentes, en el que el clopidogrel y el ácido acetilsalicílico están presentes en una relación molar de clopidogrel / ácido acetilsalicílico entre 0,35 y 0,45. Reivindicación 6: Un procedimiento para fabricar un comprimido según una cualquiera de las reivindicaciones 1 a 5, comprendiendo dicho procedimiento las siguientes etapas:(i) preparar un núcleo que comprende ácido acetilsalicílico o una de sus sales farmacéuticamente aceptables, (ii) recubrir el núcleo, de modo que se obtenga un núcleo recubierto, con un recubrimiento de tres capas compuesto de una capa gastrorresistente insertada entre dos capas aislantes, (iii) recubrir por compresión el núcleo recubierto obtenido en la etapa (ii) con el polvo que comprende el clopidogrel o una de sus sales farmacéuticamente aceptables, para obtener de este modo un comprimido. Reivindicación 13: El comprimido según una cualquiera de las reivindicaciones 1 a 5, para uso en el tratamiento de una condición patológica inducida por agregación plaquetaria, incluyendo angina estable o inestable, trastornos del sistema cardiovascular y cerebrovascular, por ejemplo trastornos tromboembólicos asociados con ateroesclerosis y con diabetes, tales como angina inestable, ictus, restenosis post-angioplastia, endarterectomía o la inserción de prótesis endovasculares metálicas, otrastornos tromboembólicos asociados con la re-trombosis post-trombolisis, con el infarto, con la demencia de origen isquémico, con enfermedades arteriales periféricas, con hemodiálisis, con fibrilación auricular, o también durante el uso de prótesis vasculares, de derivaciones aortocoronarias, o también durante la radioterapia con el fin de reducir los efectos secundarios de la misma.
ARP140102898A 2013-08-02 2014-08-01 Comprimidos farmacéuticos que comprenden ácido acetilsalicílico y clopidogrel AR097193A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/FR2013/051874 WO2015015062A1 (fr) 2013-08-02 2013-08-02 Comprime pharmaceutique comprenant de l'acide acetylsalicylique et du clopidogrel

Publications (1)

Publication Number Publication Date
AR097193A1 true AR097193A1 (es) 2016-02-24

Family

ID=49085055

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP140102898A AR097193A1 (es) 2013-08-02 2014-08-01 Comprimidos farmacéuticos que comprenden ácido acetilsalicílico y clopidogrel

Country Status (17)

Country Link
EP (1) EP3027176B1 (es)
JP (1) JP5905165B2 (es)
KR (1) KR102243349B1 (es)
CN (1) CN105407877B (es)
AR (1) AR097193A1 (es)
BR (1) BR112016001822B1 (es)
CL (1) CL2016000143A1 (es)
CR (1) CR20160067A (es)
DO (1) DOP2016000024A (es)
ES (1) ES2648913T3 (es)
HK (1) HK1221649A1 (es)
MY (1) MY176793A (es)
PE (1) PE20160212A1 (es)
PH (1) PH12016500121B1 (es)
SG (1) SG11201600218SA (es)
TW (1) TWI642435B (es)
WO (2) WO2015015062A1 (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104800183B (zh) * 2015-04-14 2016-08-31 陕西必康制药集团控股有限公司 一种阿司匹林肠溶片及其制备方法和应用
CN108289849A (zh) * 2015-06-26 2018-07-17 韩国联合制药株式会社 莫沙必利与雷贝拉唑的复合制剂
WO2017037741A1 (en) * 2015-09-02 2017-03-09 Sun Pharmaceutical Industries Ltd Compact solid dosage form of aspirin and clopidogrel
CN107308157B (zh) * 2017-06-08 2020-02-21 广州白云山天心制药股份有限公司 一种含有氯吡格雷的复方口服固体制剂及其制备方法
WO2019030610A1 (en) * 2017-08-11 2019-02-14 Solutions In Innovative Research Pvt. Ltd. PHARMACEUTICAL COMPOSITIONS WITH DUAL DIRECTLY COMPRESSIBLE MEDICAMENT RELEASE
CN107669690A (zh) * 2017-10-23 2018-02-09 罗铭炽 一种含阿司匹林和氯吡格雷的片剂
CN107693524A (zh) * 2017-10-23 2018-02-16 罗铭炽 一种含阿司匹林和氯吡格雷的制备方法
CN109528668A (zh) * 2018-12-20 2019-03-29 华中药业股份有限公司 阿司匹林片及其制备方法
CN112587495A (zh) * 2020-12-14 2021-04-02 乐普药业股份有限公司 一种阿司匹林和硫酸氢氯吡格雷复方制剂及其制备方法
EP4091605A1 (en) 2021-05-19 2022-11-23 G.L. Pharma GmbH Pharmaceutical tablet comprising acetylsalicylic acid
CN115212180B (zh) * 2022-09-03 2024-05-10 深圳市信宜特科技有限公司 一种阿司匹林和硫酸氢氯吡格雷的复方制剂及其制备方法
KR20240050841A (ko) * 2022-10-12 2024-04-19 일양약품주식회사 클로피도그렐 및 일라프라졸을 포함하는 복합제제

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04346930A (ja) * 1991-05-25 1992-12-02 Sumitomo Pharmaceut Co Ltd 安定なアスピリン腸溶錠
FR2744918B1 (fr) 1996-02-19 1998-05-07 Sanofi Sa Nouvelles associations de principes actifs contenant un derive de thieno(3,2-c)pyridine et un antithrombotique
FR2779726B1 (fr) 1998-06-15 2001-05-18 Sanofi Sa Forme polymorphe de l'hydrogenosulfate de clopidogrel
FR2792836B3 (fr) * 1999-04-30 2001-07-27 Sanofi Sa Composition pharmaceutique sous forme unitaire contenant de l'aspirine et de l'hydrogenosulfate de clopidogrel
CN101703513B (zh) * 2009-11-10 2014-04-23 沈阳药科大学 阿司匹林和氯吡格雷或其药学上可接受的盐的复方缓释制剂
CA2792232C (en) * 2010-03-11 2014-07-15 Wockhardt Limited A device for the manufacture of a dosage form with a hole and method of manufacture
CN101874786B (zh) * 2010-06-05 2012-04-25 浙江金华康恩贝生物制药有限公司 无溶剂挤出滚圆法制备阿司匹林肠溶制剂
KR20120068277A (ko) * 2010-12-17 2012-06-27 한미사이언스 주식회사 HMG-CoA 환원효소 억제제 및 아스피린을 포함하는 약제학적 복합제제
EP2755641A4 (en) * 2011-09-14 2015-03-18 Pozen Inc CONTROLLED DOSAGE OF CLOPIDOGREL IN MAGIC ACID INHIBITION THERAPIES
KR101675501B1 (ko) * 2011-11-02 2016-11-14 한국유나이티드제약 주식회사 클로피도그렐 및 아스피린의 복합제제
KR101473268B1 (ko) * 2012-03-09 2014-12-16 주식회사유한양행 클로피도그렐과 아스피린을 포함하는 약학 조성물 및 그의 제조방법

Also Published As

Publication number Publication date
KR102243349B1 (ko) 2021-04-21
PE20160212A1 (es) 2016-05-09
ES2648913T3 (es) 2018-01-08
CL2016000143A1 (es) 2016-06-24
SG11201600218SA (en) 2016-02-26
CN105407877B (zh) 2019-05-07
CR20160067A (es) 2016-04-01
TW201601721A (zh) 2016-01-16
KR20160037967A (ko) 2016-04-06
HK1221649A1 (zh) 2017-06-09
DOP2016000024A (es) 2016-03-30
JP2015526498A (ja) 2015-09-10
PH12016500121A1 (en) 2016-04-25
EP3027176A1 (en) 2016-06-08
MY176793A (en) 2020-08-21
BR112016001822B1 (pt) 2022-10-18
PH12016500121B1 (en) 2016-04-25
BR112016001822A2 (pt) 2017-08-01
EP3027176B1 (en) 2017-08-23
WO2015014766A1 (en) 2015-02-05
WO2015015062A1 (fr) 2015-02-05
CN105407877A (zh) 2016-03-16
JP5905165B2 (ja) 2016-04-20
TWI642435B (zh) 2018-12-01

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