PE20121131A1 - Composicion farmaceutica oral solida en comprimido monocapa que comprende irbesartan y besilato de amlodipina - Google Patents

Composicion farmaceutica oral solida en comprimido monocapa que comprende irbesartan y besilato de amlodipina

Info

Publication number
PE20121131A1
PE20121131A1 PE2011002177A PE2011002177A PE20121131A1 PE 20121131 A1 PE20121131 A1 PE 20121131A1 PE 2011002177 A PE2011002177 A PE 2011002177A PE 2011002177 A PE2011002177 A PE 2011002177A PE 20121131 A1 PE20121131 A1 PE 20121131A1
Authority
PE
Peru
Prior art keywords
irbesartan
monocapa
amlodipine besylate
pharmaceutical composition
solid oral
Prior art date
Application number
PE2011002177A
Other languages
English (en)
Inventor
Praveen Khullar
Vinay Kolhe
Amol Kulkarni
Shirishbay Patel
Yashwant Phadke
D Saravanan
Mansing Shingte
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=41460800&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20121131(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 PE20121131A1 publication Critical patent/PE20121131A1/es

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
    • 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
    • A61K31/41—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
    • A61K31/41—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
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting 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
    • 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
    • A61K9/282—Organic compounds, e.g. fats
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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

Landscapes

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

Abstract

REFERIDA A UNA COMPOSICION DE DOSIS FIJA FARMACEUTICA, ORAL, SOLIDA, ESTABLE QUE COMPRENDE: A) IRBESARTAN EN FORMA DE GRANULOS RECUBIERTOS EN 20-70% EN PESO DE LA COMPOSICION TOTAL; B) BESILATO DE AMLODIPINA EN 1-20% EN PESO DE LA COMPOSICION TOTAL Y C) EXCIPIENTES FARMACEUTICAMENTE ACEPTABLES TALES COMO DILUYENTE, DISGREGANTE, ANTIADHERENTE, AGLUTINANTE, LUBRICANTE, ENTRE OTROS.DICHA COMPOSICION ESTA EXCENTA DE LACTOSA Y PUEDE SER EL TRATAMIENTO DE SEGUNDA LINEA PARA PACIENTES HIPERTENSOS NO CONTROLADOS SUFICIENTEMENTE USANDO AMLODIPINA COMO MONOTERAPIA DE BLOQUEANTES DE LOS CANALES DE CALCIO (CCB) O IRBESARTAN COMO ANTAGONISTA DE LOS RECEPTORES DE LA ANGIOTENSINA II (ARB)
PE2011002177A 2009-06-30 2009-09-17 Composicion farmaceutica oral solida en comprimido monocapa que comprende irbesartan y besilato de amlodipina PE20121131A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN1341DE2009 2009-06-30

Publications (1)

Publication Number Publication Date
PE20121131A1 true PE20121131A1 (es) 2012-09-04

Family

ID=41460800

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2011002177A PE20121131A1 (es) 2009-06-30 2009-09-17 Composicion farmaceutica oral solida en comprimido monocapa que comprende irbesartan y besilato de amlodipina

Country Status (40)

Country Link
US (1) US9173848B2 (es)
EP (1) EP2448561B1 (es)
JP (1) JP5763063B2 (es)
KR (1) KR101667081B1 (es)
CN (2) CN106176745A (es)
AR (1) AR077284A1 (es)
AU (1) AU2009349125B2 (es)
BR (1) BRPI0925315B8 (es)
CA (1) CA2766884C (es)
CL (1) CL2011003371A1 (es)
CO (1) CO6480972A2 (es)
CR (1) CR20110704A (es)
CY (1) CY1114933T1 (es)
DK (1) DK2448561T3 (es)
DO (1) DOP2011000406A (es)
EA (1) EA021317B1 (es)
EC (1) ECSP11011559A (es)
ES (1) ES2435240T3 (es)
GT (1) GT201100337A (es)
HK (1) HK1169309A1 (es)
HR (1) HRP20131088T1 (es)
IL (1) IL217229A (es)
MA (1) MA33463B1 (es)
MX (1) MX2011014005A (es)
MY (1) MY152951A (es)
NI (1) NI201100227A (es)
NZ (1) NZ597317A (es)
PE (1) PE20121131A1 (es)
PL (1) PL2448561T3 (es)
PT (1) PT2448561E (es)
RS (1) RS53087B (es)
SG (1) SG177426A1 (es)
SI (1) SI2448561T1 (es)
SM (1) SMT201400011B (es)
TN (1) TN2011000651A1 (es)
TW (1) TWI476191B (es)
UA (1) UA103688C2 (es)
UY (1) UY32749A (es)
WO (1) WO2011001202A1 (es)
ZA (1) ZA201109541B (es)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6041591B2 (ja) * 2011-09-13 2016-12-14 大日本住友製薬株式会社 イルベサルタンとアムロジピンまたはその塩を含有する安定化された医薬組成物
KR20150078215A (ko) * 2013-12-30 2015-07-08 (주) 드림파마 에프로사탄 및 암로디핀을 포함하는 복합제제 및 이의 제조방법
CN104758283A (zh) * 2014-01-02 2015-07-08 江苏吉贝尔药业有限公司 一种抗高血压制剂
CN104000821B (zh) * 2014-06-02 2020-06-19 浙江华海药业股份有限公司 含有替米沙坦和苯磺酸氨氯地平的口服双层片剂及其制备方法
EP3244880A1 (en) * 2015-01-12 2017-11-22 Ilko Ilaç Sanayi Ve Ticaret Anonim Sirketi A stable bilayer pharmaceutical tablet compositions comprising fixed dose of irbesartan and amlodipine
JP6737060B2 (ja) * 2015-09-11 2020-08-05 ニプロ株式会社 イルベサルタンを含有する医薬組成物の製造方法
US10350171B2 (en) 2017-07-06 2019-07-16 Dexcel Ltd. Celecoxib and amlodipine formulation and method of making the same
CN111212641A (zh) * 2017-10-13 2020-05-29 联合化学工业公司实验室有限公司 阿普斯特的药物组合物
CN108578404B (zh) * 2018-04-28 2020-04-28 广州白云山天心制药股份有限公司 一种含厄贝沙坦和氨氯地平的药用组合物及其制备方法
GR1010320B (el) * 2021-08-04 2022-10-11 Win Medica Φαρμακευτικη Ανωνυμη Εταιρεια, Στερεες φαρμακοτεχνικες μορφες ιρβεσαρτανης, υδροχλωροθειαζιδης και αμλοδιπινης

Family Cites Families (15)

* Cited by examiner, † Cited by third party
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US5994348A (en) * 1995-06-07 1999-11-30 Sanofi Pharmaceutical compositions containing irbesartan
TW442301B (en) * 1995-06-07 2001-06-23 Sanofi Synthelabo Pharmaceutical compositions containing irbesartan
JP4829115B2 (ja) * 2003-10-10 2011-12-07 ゾルファイ ファーマスーティカルズ ゲゼルシャフト ミット ベシュレンクテル ハフツング 選択的ｉ１イミダゾリンレセプターアゴニストおよびアンギオテンシンｉｉレセプターブロッカーを含有する医薬組成物
US20050187262A1 (en) * 2004-01-12 2005-08-25 Grogan Donna R. Compositions comprising (S)-amlodipine and an angiotensin receptor blocker and methods of their use
BE1015867A3 (fr) 2004-01-22 2005-10-04 Sonaca Sa Ensemble de bord d'attaque d'un element de voilure d'aeronef et element de voilure equipee d'au moins un tel ensemble.
US20050250838A1 (en) * 2004-05-04 2005-11-10 Challapalli Prasad V Formulation for sustained delivery
CN100364532C (zh) * 2004-09-30 2008-01-30 江苏恒瑞医药股份有限公司 包含氨氯地平和血管紧张素ⅱ受体抑制剂的组合物
ATE451925T1 (de) * 2004-10-06 2010-01-15 Eisai R&D Man Co Ltd Medizinische zusammensetzung, verfahren zu ihrer herstellung und verfahren zur stabilisierung einer dihydropyridin-verbindung in einer medizinischen zusammensetzung
EA013053B1 (ru) * 2004-11-05 2010-02-26 Бёрингер Ингельхайм Интернациональ Гмбх Двуслойная таблетка, содержащая телмисартан и амлодипин
WO2007001067A2 (en) * 2005-06-27 2007-01-04 Daiichi Sankyo Company, Limited Solid dosage form comprising an angiotensin ii receptor antagonist and a calcium channel blocker
WO2007001065A2 (en) * 2005-06-27 2007-01-04 Daiichi Sankyo Company, Limited Method for the preparation of a wet granulated drug product
CN101247832B (zh) * 2005-06-27 2011-12-28 第一三共株式会社 含有血管紧张素ⅱ受体拮抗剂和钙通道阻断剂的药物制剂
KR100888131B1 (ko) * 2006-10-10 2009-03-11 한올제약주식회사 시간차 투약 원리를 이용한 심혈관계 질환 치료용 복합제제
KR101247583B1 (ko) * 2006-12-08 2013-03-26 한미사이언스 주식회사 암로디핀 또는 이의 약제학적 허용가능한 염, 및 로자탄또는 이의 약제학적 허용가능한 염을 함유하는 약제학적조성물
TWI402083B (zh) * 2006-12-26 2013-07-21 Daiichi Sankyo Co Ltd 固形製劑及其安定化方法

Also Published As

Publication number Publication date
WO2011001202A1 (en) 2011-01-06
CO6480972A2 (es) 2012-07-16
HRP20131088T1 (hr) 2013-12-20
ZA201109541B (en) 2013-03-27
EA201270087A1 (ru) 2012-07-30
UA103688C2 (uk) 2013-11-11
MA33463B1 (fr) 2012-07-03
GT201100337A (es) 2014-05-20
CL2011003371A1 (es) 2012-07-27
AU2009349125B2 (en) 2016-05-19
NZ597317A (en) 2014-05-30
US9173848B2 (en) 2015-11-03
NI201100227A (es) 2012-03-28
CA2766884A1 (en) 2011-01-06
AU2009349125A1 (en) 2012-01-19
TWI476191B (zh) 2015-03-11
CN102573804A (zh) 2012-07-11
AR077284A1 (es) 2011-08-17
CA2766884C (en) 2016-08-23
CY1114933T1 (el) 2016-12-14
DK2448561T3 (da) 2013-11-25
EP2448561B1 (en) 2013-08-14
KR20120102579A (ko) 2012-09-18
PT2448561E (pt) 2013-11-21
CR20110704A (es) 2012-06-15
JP2012532118A (ja) 2012-12-13
ES2435240T3 (es) 2013-12-17
KR101667081B1 (ko) 2016-10-17
UY32749A (es) 2011-01-31
SMT201400011B (it) 2014-03-07
DOP2011000406A (es) 2012-04-15
US20120171288A1 (en) 2012-07-05
MX2011014005A (es) 2012-04-30
TN2011000651A1 (en) 2013-05-24
SI2448561T1 (sl) 2013-12-31
JP5763063B2 (ja) 2015-08-12
TW201111368A (en) 2011-04-01
RS53087B (en) 2014-06-30
SG177426A1 (en) 2012-02-28
IL217229A (en) 2016-10-31
BRPI0925315B8 (pt) 2021-05-25
BRPI0925315B1 (pt) 2019-10-08
MY152951A (en) 2014-12-15
PL2448561T3 (pl) 2014-01-31
EP2448561A1 (en) 2012-05-09
ECSP11011559A (es) 2012-01-31
IL217229A0 (en) 2012-07-31
EA021317B1 (ru) 2015-05-29
HK1169309A1 (en) 2013-01-25
CN106176745A (zh) 2016-12-07

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