EA201390603A1 - MULTI-LAYER PHARMACEUTICAL COMPOSITION CONTAINING TELMISARTAN AND AMLODIPIPIN - Google Patents

MULTI-LAYER PHARMACEUTICAL COMPOSITION CONTAINING TELMISARTAN AND AMLODIPIPIN

Info

Publication number
EA201390603A1
EA201390603A1 EA201390603A EA201390603A EA201390603A1 EA 201390603 A1 EA201390603 A1 EA 201390603A1 EA 201390603 A EA201390603 A EA 201390603A EA 201390603 A EA201390603 A EA 201390603A EA 201390603 A1 EA201390603 A1 EA 201390603A1
Authority
EA
Eurasian Patent Office
Prior art keywords
pharmaceutical composition
composition containing
containing telmisartan
amlodipipin
layer pharmaceutical
Prior art date
Application number
EA201390603A
Other languages
Russian (ru)
Other versions
EA025946B1 (en
Inventor
Грегор Седмак
Силво Зупанциц
Original Assignee
Крка, Товарна Здравил, Д.Д., Ново Место
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
Application filed by Крка, Товарна Здравил, Д.Д., Ново Место filed Critical Крка, Товарна Здравил, Д.Д., Ново Место
Publication of EA201390603A1 publication Critical patent/EA201390603A1/en
Publication of EA025946B1 publication Critical patent/EA025946B1/en

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
    • A61K9/2086—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
    • 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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Изобретение относится к твердой фармацевтической композиции, содержащей телмисартан или его фармацевтически приемлемое производное, возможно один или более чем один подщелачивающий агент и по меньшей мере один блокатор кальциевых каналов. Более конкретно, в изобретении раскрыта фармацевтическая композиция, содержащая телмисартан и амлодипин, которая содержит по меньшей мере один не гигроскопичный наполнитель и/или по меньшей мере одно не гигроскопичное связующее вещество, которое не проявляет разрыхляющего эффекта, и/или по меньшей мере одно гидрофильное смазывающее вещество.The invention relates to a solid pharmaceutical composition containing telmisartan or a pharmaceutically acceptable derivative thereof, optionally one or more alkalizing agents and at least one calcium channel blocker. More specifically, the invention discloses a pharmaceutical composition containing telmisartan and amlodipine, which contains at least one non-hygroscopic excipient and/or at least one non-hygroscopic binder that does not exhibit a disintegrating effect and/or at least one hydrophilic lubricant. substance.

EA201390603A 2010-10-27 2011-10-26 Multilayer pharmaceutical composition comprising telmisartan and amlodipine EA025946B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SI201000347 2010-10-27
SI201100118 2011-03-30
PCT/EP2011/068806 WO2012055941A1 (en) 2010-10-27 2011-10-26 Multilayer pharmaceutical composition comprising telmisartan and amlodipine

Publications (2)

Publication Number Publication Date
EA201390603A1 true EA201390603A1 (en) 2013-11-29
EA025946B1 EA025946B1 (en) 2017-02-28

Family

ID=44907845

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201390603A EA025946B1 (en) 2010-10-27 2011-10-26 Multilayer pharmaceutical composition comprising telmisartan and amlodipine

Country Status (3)

Country Link
EP (1) EP2632438A1 (en)
EA (1) EA025946B1 (en)
WO (1) WO2012055941A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX358211B (en) 2012-07-23 2018-08-10 Landsteiner Scient S A De C V New differential-release pharmaceutical composition containing three active principles.
WO2014091263A1 (en) * 2012-12-11 2014-06-19 Egis Pharmaceuticals Public Limited Company Telmisartan containing pharmaceutical composition
CN103271908B (en) * 2013-05-23 2019-02-12 浙江华海药业股份有限公司 Oral tablet and preparation method thereof containing Telmisartan and Amlodipine Besylate Tablet
CN104000821B (en) * 2014-06-02 2020-06-19 浙江华海药业股份有限公司 Oral double-layer tablet containing telmisartan and amlodipine besylate and preparation method thereof
CN106619552B (en) * 2017-01-04 2018-05-25 北京汇诚瑞祥医药技术有限公司 A kind of telmisartan amlodipine fast-release tablet and preparation method thereof
WO2024163030A1 (en) * 2023-02-03 2024-08-08 Brillian Pharma Inc. Amlodipine freeze-dried compositions and uses thereof

Family Cites Families (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK161312C (en) 1982-03-11 1991-12-09 Pfizer CHANGES FOR THE PREPARATION FOR THE PREPARATION OF 2-Amino-CO-Methyl-4-Methyl-4-Methyl-4-Methyl-4-Methyl-4-Methyl-4-Methyl-2-D-Hydroxy
SI9210098B (en) 1991-02-06 2000-06-30 Dr. Karl Thomae Benzimidazoles, drugs with this compounds, and process for their preparation
AUPO042396A0 (en) 1996-06-14 1996-07-04 Procter & Gamble Company, The Laundry detergent bar containing magnesium sulfate with improved physical properties
DE19727133A1 (en) 1997-06-26 1999-01-07 Thomson Brandt Gmbh Method, device and recording device for suppressing pulse-like interference in analog audio and / or video signals
DE19901921C2 (en) 1999-01-19 2001-01-04 Boehringer Ingelheim Pharma Polymorphs of telmisartan, process for their preparation and their use in the manufacture of a medicament
DE19917524C2 (en) 1999-04-17 2001-09-20 Boehringer Ingelheim Pharma Process for the nitration of aniline derivatives
DE10153737A1 (en) 2001-10-31 2003-05-28 Boehringer Ingelheim Pharma Crystalline sodium salt of telmisartan, process for its preparation and its use for the manufacture of a medicament
DE10314702A1 (en) 2003-03-31 2004-10-21 Boehringer Ingelheim Pharma Gmbh & Co. Kg Process for the preparation of telmisartan
CN1548421A (en) 2003-05-22 2004-11-24 上海医药工业研究院 Tilmisartan salt and its prepn
GB2414019A (en) 2004-05-11 2005-11-16 Cipla Ltd One-step preparation of telmisartan by condensation and hydrolysis
JP2008503595A (en) 2004-10-15 2008-02-07 テバ ファーマシューティカル インダストリーズ リミティド Preparation of telmisartan
US7943781B2 (en) 2004-10-18 2011-05-17 Dr. Reddy's Laboratories Limited Process for preparing telmisartan
MX2007005348A (en) 2004-11-03 2007-06-25 Teva Pharma Amorphous and polymorphic forms of telmisartan sodium.
SI1814527T1 (en) * 2004-11-05 2014-03-31 Boehringer Ingelheim International Gmbh Bilayer tablet comprising telmisartan and amlodipine
EP1824833A2 (en) 2004-11-11 2007-08-29 LEK Pharmaceuticals D.D. Preparation of telmisartan salts with improved solubility
US20060111417A1 (en) 2004-11-23 2006-05-25 Purandhar Koilkonda Amorphous telmisartan
DE602005007384D1 (en) 2004-12-22 2008-07-17 Algry Quimica S L INTERMEDIATE PRODUCTS FOR THE MANUFACTURE OF ANTAGONISTS OF THE ANGIOTENSIN II RECEPTOR
US20060211866A1 (en) 2005-03-21 2006-09-21 Glenmark Pharmaceuticals Limited Process for the preparation of angiotensin receptor blockers and intermediates thereof
ITMI20050801A1 (en) 2005-05-03 2006-11-04 Dipharma Spa PROCEDURE FOR THE PREPARATION OF TELMISARTAN
IL175718A0 (en) 2005-05-18 2007-08-19 Chemagis Ltd Novel processes for preparing crystalline telmisartan form a by crystallization from dmf
TWI388345B (en) 2005-06-27 2013-03-11 Sankyo Co Solid dosage form comprising angiotensin iireceptor antagonist and calcium channel blocker for prophylaxis or treatment of hypertension
WO2007010558A1 (en) 2005-07-19 2007-01-25 Matrix Laboratories Limited A process for the preparation of telmisartan
US20060264491A1 (en) 2006-06-08 2006-11-23 Chemagis Ltd. Telmisartan production process
SI22297A (en) 2006-06-23 2007-12-31 Krka, Tovarna Zdravil, D.D., Novo Mesto Preparation of salt of telmisartan
KR100888131B1 (en) * 2006-10-10 2009-03-11 한올제약주식회사 Combination preparation for Cardiovascular disease therapy by Chronotherapy theory.
KR101247583B1 (en) * 2006-12-08 2013-03-26 한미사이언스 주식회사 Pharmaceutical composition comprising amlodipine or a pharmaceutically acceptable salt thereof and losartan or a pharmaceutically acceptable salt thereof
CN100460396C (en) 2007-03-08 2009-02-11 杭州盛美医药科技开发有限公司 Intermediate of telmisartan, its preparation and use
EP2167048B1 (en) * 2007-05-30 2016-10-26 Wockhardt Limited A novel tablet dosage form
EA200901619A1 (en) 2007-07-03 2010-04-30 Крка, Товарна Здравил, Д. Д., Ново Место METHOD OF OBTAINING TELMISARTANA
CZ302272B6 (en) 2007-07-09 2011-01-19 Zentiva, A. S. Process for preparing 4?-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1yl]methyl]biphenyl-2-carboxylic acid (telmisartan)
WO2009116089A2 (en) 2008-03-14 2009-09-24 Ipca Laboratories Limited Novel intermediates and method for synthesis of 4'-[(1,4'-dimethyl-2'-propyl-[2,6'- bi-1hbenzimidazol]-l-yl)methyl]-1,1-biphenyl]-2-carboxylic acid.
WO2009115585A1 (en) 2008-03-20 2009-09-24 Lek Pharmaceuticals D.D. Catalyzed carbonylation in the synthesis of angiotensin ii antagonists
WO2009123483A1 (en) 2008-03-31 2009-10-08 Zaklady Farmaceutyczne Polpharma Sa Process for preparation of telmisartan
EP2123648A1 (en) 2008-05-20 2009-11-25 Chemo Ibérica, S.A. A process for the preparation of Telmisartan.
WO2010004385A1 (en) 2008-06-17 2010-01-14 Aurobindo Pharma Limited Process for the preparation of pure 4'-[4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl]methyl]-2-biphenylcarboxylic acid
WO2010018441A2 (en) 2008-08-11 2010-02-18 Cadila Pharmaceuticals Ltd. An improved process for the preparation of substantially pure telmisartan
CN102438598B (en) * 2009-05-27 2015-06-10 株式会社茶山医化 Multi-layer tablet comprising effervescent layer
ES2415357T3 (en) 2009-06-19 2013-07-25 Krka Tovarna Zdravil, D.D., Novo Mesto Procedure for the preparation of telmisartan
EP2277866A1 (en) 2009-06-22 2011-01-26 Inke, S.A. Process for preparing telmisartan
CN101983962A (en) 2010-12-07 2011-03-09 福州海王福药制药有限公司 Preparation technology of telmisartan active pharmaceutical ingredient

Also Published As

Publication number Publication date
WO2012055941A1 (en) 2012-05-03
EP2632438A1 (en) 2013-09-04
EA025946B1 (en) 2017-02-28

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Legal Events

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG MD TJ TM