RO128004A3 - Compoziţie farmaceutică cu eliberare prelungită a trimetazidinei - Google Patents

Compoziţie farmaceutică cu eliberare prelungită a trimetazidinei Download PDF

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Publication number
RO128004A3
RO128004A3 ROA201200317A RO201200317A RO128004A3 RO 128004 A3 RO128004 A3 RO 128004A3 RO A201200317 A ROA201200317 A RO A201200317A RO 201200317 A RO201200317 A RO 201200317A RO 128004 A3 RO128004 A3 RO 128004A3
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RO
Romania
Prior art keywords
trimetazidine
appear
plasticizer
binder
outer packaging
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Application number
ROA201200317A
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English (en)
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RO128004A0 (ro
Inventor
Patrick Genty
Christophe Hermelin
Jean Manuel Pean
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Les Laboratoires Servier
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Application filed by Les Laboratoires Servier filed Critical Les Laboratoires Servier
Publication of RO128004A0 publication Critical patent/RO128004A0/ro
Publication of RO128004A3 publication Critical patent/RO128004A3/ro

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    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • 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
    • 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
    • A61K9/2009—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
    • A61K9/2022—Organic macromolecular 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
    • A61K9/2022—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
    • A61K9/2077—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
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • 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
    • A61P9/08—Vasodilators for multiple indications
    • 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
    • A61P9/10—Drugs 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

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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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Otolaryngology (AREA)
  • Hospice & Palliative Care (AREA)
  • Ophthalmology & Optometry (AREA)
  • Vascular Medicine (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Invenţia se referă la o compoziţie farmaceutică ce are eliberare prelungită a trimetazidinei, şi la un procedeu de preparare a acesteia, utilizată pentru tratamentul anginei pectorale, a dereglărilor coronariene, precum şi a ameţelilor de origine vasculară. Compoziţia conform invenţiei este constituită dintr-un nucleu neutru, o fază internă care cuprinde trimetazidină şi un liant, un strat extern care cuprinde un agent de întârziere, un antiaglomerant şi un plastifiant. Procedeul conform invenţiei constă din acoperirea nucleului neutru succesiv cu trimetazidină şi liant, apoi cu un agent de întârziere, un plastifiant şi un aglomerant, după care minigranulele rezultate se condiţionează, pentru obţinerea profilului de dizolvare a trimetazidinei, care asigură o concentraţie plasmatică eficientă terapeutic.
ROA201200317A 2012-02-03 2012-05-09 Compoziţie farmaceutică cu eliberare prelungită a trimetazidinei RO128004A3 (ro)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1200322A FR2986431B1 (fr) 2012-02-03 2012-02-03 Composition pharmaceutique a liberation prolongee de trimetazidine, son procede de fabrication et son utilisation dans des traitements therapeutiques

Publications (2)

Publication Number Publication Date
RO128004A0 RO128004A0 (ro) 2012-12-28
RO128004A3 true RO128004A3 (ro) 2013-08-30

Family

ID=47504206

Family Applications (1)

Application Number Title Priority Date Filing Date
ROA201200317A RO128004A3 (ro) 2012-02-03 2012-05-09 Compoziţie farmaceutică cu eliberare prelungită a trimetazidinei

Country Status (48)

Country Link
US (1) US10117838B2 (ro)
EP (1) EP2623096B1 (ro)
JP (1) JP6338818B2 (ro)
KR (2) KR20130090365A (ro)
CN (2) CN103239425A (ro)
AP (1) AP2013006693A0 (ro)
AR (1) AR089861A1 (ro)
AU (1) AU2013200481B2 (ro)
BR (1) BR102013002524B1 (ro)
CA (1) CA2805471C (ro)
CL (1) CL2013000336A1 (ro)
CO (1) CO6720159A1 (ro)
CR (1) CR20130037A (ro)
CU (1) CU24157B1 (ro)
CY (1) CY1121696T1 (ro)
DK (1) DK2623096T3 (ro)
DO (1) DOP2013000024A (ro)
EA (1) EA030227B1 (ro)
EC (1) ECSP13012415A (ro)
ES (1) ES2735053T3 (ro)
FR (1) FR2986431B1 (ro)
GE (1) GEP20156342B (ro)
GT (1) GT201300032A (ro)
HR (2) HRP20130082A2 (ro)
HU (1) HUE043942T2 (ro)
IL (1) IL224495B (ro)
JO (1) JO3505B1 (ro)
LT (1) LT2623096T (ro)
MD (1) MD4622C1 (ro)
MX (1) MX363302B (ro)
MY (1) MY162599A (ro)
NI (1) NI201300014A (ro)
PE (1) PE20131119A1 (ro)
PH (1) PH12013000031A1 (ro)
PL (1) PL2623096T3 (ro)
PT (1) PT2623096T (ro)
PY (1) PY1303869A (ro)
RO (1) RO128004A3 (ro)
RS (2) RS20130034A1 (ro)
RU (1) RU2621128C2 (ro)
SG (1) SG192386A1 (ro)
SI (1) SI2623096T1 (ro)
SV (1) SV2013004396A (ro)
TR (1) TR201906390T4 (ro)
TW (1) TWI508755B (ro)
UA (1) UA118742C2 (ro)
UY (1) UY34595A (ro)
WO (1) WO2013114053A2 (ro)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102322197B1 (ko) * 2014-04-08 2021-11-09 뉴트리션 ＆ 바이오사이언시즈 유에스에이 1, 엘엘씨 에스테르화된 셀룰로오스 에테르를 포함하는 분산물
CA3044270A1 (en) 2016-11-21 2018-05-24 Saghmos Therapeutics, Inc. The use of trimetazidine in the prevention and/or treatment of contrast-induced acute kidney injury____
CN109316455B (zh) * 2017-07-31 2021-05-25 北京福元医药股份有限公司 一种盐酸曲美他嗪缓释片
CN110237053A (zh) * 2019-07-26 2019-09-17 湖北欣泽霏药业有限公司 一种盐酸曲美他嗪缓释微丸及其制备方法
KR20250035269A (ko) * 2023-09-05 2025-03-12 주식회사 뉴캔서큐어바이오 트리메타지딘을 포함하는 코팅정 조성물 및 이의 제조방법
WO2025068837A2 (en) * 2023-09-26 2025-04-03 Zim Laboratories Limited A novel extended release pharmaceutical composition of trimetazidine or salt thereof

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FR2490963B1 (fr) 1980-09-30 1986-04-18 Science Union & Cie Nouvelle composition therapeutique a action anti-ischemique contenant de la trimethoxy 2, 3, 4-benzyl 1-piperazine
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FR2717687B1 (fr) * 1994-03-24 1996-06-14 Adir Compositions pharmaceutiques permettant la libération prolongée de trimétazidine après administration par voie orale.
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CN101854929A (zh) * 2007-11-09 2010-10-06 田边三菱制药株式会社 新型制剂
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JP2012515757A (ja) * 2009-01-20 2012-07-12 マイクロ ラブス リミテッド トリメタジジンの放出調節固形薬剤組成物及びその製造方法
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Also Published As

Publication number Publication date
RS20130034A1 (sr) 2013-10-31
UA118742C2 (uk) 2019-03-11
CL2013000336A1 (es) 2014-07-18
CR20130037A (es) 2013-09-18
GT201300032A (es) 2014-06-09
PL2623096T3 (pl) 2019-08-30
GEP20156342B (en) 2015-08-10
EA030227B1 (ru) 2018-07-31
DK2623096T3 (da) 2019-07-15
NZ606550A (en) 2014-09-26
SI2623096T1 (sl) 2019-06-28
JP2013159609A (ja) 2013-08-19
AU2013200481A1 (en) 2013-08-22
MD20130005A2 (ro) 2013-07-31
WO2013114053A2 (fr) 2013-08-08
HRP20130082A2 (hr) 2013-08-31
CN106924221A (zh) 2017-07-07
MX363302B (es) 2019-03-20
PH12013000031B1 (en) 2014-09-22
CO6720159A1 (es) 2013-07-31
JP6338818B2 (ja) 2018-06-06
IL224495B (en) 2020-08-31
AP2013006693A0 (en) 2013-01-31
MD4622C1 (ro) 2019-10-31
SV2013004396A (es) 2013-06-05
AR089861A1 (es) 2014-09-24
FR2986431A1 (fr) 2013-08-09
HRP20191072T1 (hr) 2019-11-01
PE20131119A1 (es) 2013-10-12
MD4622B1 (ro) 2019-03-31
KR101918211B1 (ko) 2018-11-14
ES2735053T3 (es) 2019-12-13
UY34595A (es) 2013-09-02
CY1121696T1 (el) 2020-07-31
RS58752B1 (sr) 2019-06-28
TR201906390T4 (tr) 2019-05-21
HUE043942T2 (hu) 2019-09-30
CA2805471A1 (fr) 2013-08-03
JO3505B1 (ar) 2020-07-05
NI201300014A (es) 2013-05-13
CU24157B1 (es) 2016-03-31
MY162599A (en) 2017-06-30
RO128004A0 (ro) 2012-12-28
US20130202710A1 (en) 2013-08-08
TWI508755B (zh) 2015-11-21
BR102013002524B1 (pt) 2020-02-04
EP2623096A2 (fr) 2013-08-07
CN103239425A (zh) 2013-08-14
LT2623096T (lt) 2019-05-10
EP2623096A3 (fr) 2013-10-23
WO2013114053A3 (fr) 2013-12-19
DOP2013000024A (es) 2014-07-15
RU2621128C2 (ru) 2017-05-31
EA201300079A2 (ru) 2013-07-30
MX2013001118A (es) 2013-08-27
BR102013002524A2 (pt) 2014-09-09
US10117838B2 (en) 2018-11-06
KR20150102922A (ko) 2015-09-09
ECSP13012415A (es) 2014-09-30
KR20130090365A (ko) 2013-08-13
PY1303869A (es) 2015-11-02
TW201332591A (zh) 2013-08-16
SG192386A1 (en) 2013-08-30
AU2013200481B2 (en) 2015-01-22
FR2986431B1 (fr) 2017-03-17
PT2623096T (pt) 2019-05-30
CA2805471C (fr) 2018-05-01
RU2013104252A (ru) 2014-08-10
PH12013000031A1 (en) 2014-09-22
EA201300079A3 (ru) 2013-11-29
EP2623096B1 (fr) 2019-04-03
CU20130016A7 (es) 2014-10-02

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