WO2006063737A1 - Therapie combinatoire impliquant le telmisartan et l'hydrochlorothiazide - Google Patents

Therapie combinatoire impliquant le telmisartan et l'hydrochlorothiazide Download PDF

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Publication number
WO2006063737A1
WO2006063737A1 PCT/EP2005/013224 EP2005013224W WO2006063737A1 WO 2006063737 A1 WO2006063737 A1 WO 2006063737A1 EP 2005013224 W EP2005013224 W EP 2005013224W WO 2006063737 A1 WO2006063737 A1 WO 2006063737A1
Authority
WO
WIPO (PCT)
Prior art keywords
telmisartan
composition
hydrochlorothiazide
angiotensin
receptor antagonist
Prior art date
Application number
PCT/EP2005/013224
Other languages
English (en)
Inventor
Helmut E. Schumacher
Peter Böhm
Axel Riedel
Original Assignee
Boehringer Ingelheim International Gmbh
Boehringer Ingelheim Pharma Gmbh & Co. Kg
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=35589356&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2006063737(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim International Gmbh, Boehringer Ingelheim Pharma Gmbh & Co. Kg filed Critical Boehringer Ingelheim International Gmbh
Priority to BRPI0519656-6A priority Critical patent/BRPI0519656A2/pt
Priority to AU2005315855A priority patent/AU2005315855A1/en
Priority to EA200701159A priority patent/EA200701159A1/ru
Priority to JP2007545905A priority patent/JP2008524136A/ja
Priority to EP05814002A priority patent/EP1827424A1/fr
Priority to CA002589493A priority patent/CA2589493A1/fr
Publication of WO2006063737A1 publication Critical patent/WO2006063737A1/fr
Priority to NO20072325A priority patent/NO20072325L/no
Priority to IL183944A priority patent/IL183944A0/en

Links

Classifications

    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • 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
    • A61P9/12—Antihypertensives

Definitions

  • a target blood pressure of ⁇ 140/90 mmHg is recommended and an even lower target of ⁇ 130/80 mmHg for patients with co-morbidities such as diabetes or chronic kidney disease.
  • the tablets obtained release the active ingredients rapidly and in a largely pH- independent fashion, with complete release occurring within less than 60 min and release of the major fraction occurring within less than 15 min.
  • the dissolution/- disintegration kinetics of the multilayer tablet may be controlled in different ways.
  • the layers may dissolve/disintegrate simultaneously.
  • the tablet layer comprising HCTZ disintegrates first whereas the layer comprising telmisartan dissolves subsequently.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen- Or Sulfur-Containing Heterocyclic Ring Compounds With Rings Of Six Or More Members (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention décrit une préparation pharmaceutique comprenant environ 80 mg de telmisartan et environ 25 mg d'hydrochlorothiazide, ou environ 160 mg de telmisartan et environ 50 mg d'hydrochlorothiazide, destinée au traitement de l'hypertension chez des patients dont la pression artérielle ne diminue pas de façon suffisante lorsqu'ils sont traités soit à l'aide d'un antagoniste de récepteur de l'angiotensine II, soit à l'aide d'une préparation pharmaceutique comprenant un antagoniste de récepteur de l'angiotensine II et une faible dose d'hydrochlorothiazide.
PCT/EP2005/013224 2004-12-17 2005-12-09 Therapie combinatoire impliquant le telmisartan et l'hydrochlorothiazide WO2006063737A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
BRPI0519656-6A BRPI0519656A2 (pt) 2004-12-17 2005-12-09 terapia de combinaÇço compreendendo telmisartan e hidroclorotiazida
AU2005315855A AU2005315855A1 (en) 2004-12-17 2005-12-09 Combination therapy comprising telmisartan and hydrochlorothiazide
EA200701159A EA200701159A1 (ru) 2004-12-17 2005-12-09 Комбинированное лекарственное средство, включающее телмисартан и гидрохлортиазид
JP2007545905A JP2008524136A (ja) 2004-12-17 2005-12-09 テルミサルタンとヒドロクロロチアジドを含む併用療法
EP05814002A EP1827424A1 (fr) 2004-12-17 2005-12-09 Therapie combinatoire impliquant le telmisartan et l'hydrochlorothiazide
CA002589493A CA2589493A1 (fr) 2004-12-17 2005-12-09 Therapie combinatoire impliquant le telmisartan et l'hydrochlorothiazide
NO20072325A NO20072325L (no) 2004-12-17 2007-05-04 Kombinasjonsterapi omfattende telmisartan og hydroklortiazid
IL183944A IL183944A0 (en) 2004-12-17 2007-06-14 Combination therapy comprising telmisartan and hydrochlorothiazide

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US63706204P 2004-12-17 2004-12-17
US60/637,062 2004-12-17

Publications (1)

Publication Number Publication Date
WO2006063737A1 true WO2006063737A1 (fr) 2006-06-22

Family

ID=35589356

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/013224 WO2006063737A1 (fr) 2004-12-17 2005-12-09 Therapie combinatoire impliquant le telmisartan et l'hydrochlorothiazide

Country Status (15)

Country Link
EP (1) EP1827424A1 (fr)
JP (1) JP2008524136A (fr)
KR (1) KR20070097511A (fr)
CN (1) CN101080225A (fr)
AR (1) AR052052A1 (fr)
AU (1) AU2005315855A1 (fr)
BR (1) BRPI0519656A2 (fr)
CA (1) CA2589493A1 (fr)
EA (1) EA200701159A1 (fr)
IL (1) IL183944A0 (fr)
NO (1) NO20072325L (fr)
PE (1) PE20060768A1 (fr)
TW (1) TW200637546A (fr)
UY (1) UY29274A1 (fr)
WO (1) WO2006063737A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007060170A2 (fr) * 2005-11-24 2007-05-31 Boehringer Ingelheim International Gmbh Comprimé bicouche comprenant du telmisartan et un diurétique
WO2010013835A2 (fr) * 2008-07-31 2010-02-04 Takeda Pharmaceutical Company Limited Composition pharmaceutique solide
US20100143465A1 (en) * 2007-03-14 2010-06-10 Boehringer Ingelheim International Gmbh Pharmaceutical composition
WO2010063995A2 (fr) * 2008-12-04 2010-06-10 Arrow International Limited Telmisartan en formulations diurétiques
EP2203158A2 (fr) 2007-10-30 2010-07-07 Dr. Reddy's Laboratories, Ltd. Formulations pharmaceutiques comprenant du telmisartan et de l'hydrochlorotiazide
US20100233265A1 (en) * 2007-10-19 2010-09-16 Kai Suzuki Matrix-type pharmaceutical solid preparation
US7812046B2 (en) 2002-08-10 2010-10-12 Bethesda Pharmaceuticals, Inc. PPAR ligands that do not cause fluid retention, edema or congestive heart failure
EP2252273A1 (fr) 2008-03-19 2010-11-24 Ratiopharm GmbH Composition pharmaceutique solide incluant un antagoniste non peptidique du récepteur de l angiotensine ii et un diurétique
WO2010146187A2 (fr) 2009-06-19 2010-12-23 Krka, Tovarna Zdravil, D.D., Novo Mesto Procédé pour la préparation de telmisartan
WO2011002425A3 (fr) * 2009-07-02 2011-03-03 Bilgig Mahmut Composition pharmaceutique présentant une solubilité et une stabilité accrues
WO2011025467A1 (fr) 2009-08-24 2011-03-03 Bilgic Mahmut Formes posologiques solides comprenant du telmisartan
WO2011002423A3 (fr) * 2009-07-02 2011-03-03 Mahmut Bilgic Composition pharmaceutique augmentant la solubilité
WO2011161123A2 (fr) 2010-06-21 2011-12-29 Krka, Tovarna Zdravil, D.D., Novo Mesto Comprimé pharmaceutique multicouche comprenant du telmisartan et un diurétique
EP2952196A4 (fr) * 2013-01-31 2016-08-03 Sawai Seiyaku Kk Comprimé multicouche contenant du telmisartan et de l'hydrochlorothiazide
US10111858B2 (en) 2013-07-23 2018-10-30 Daiichi Sankyo Company, Limited Pharmaceutical for prophylaxis or treatment of hypertension

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106562973A (zh) * 2016-11-06 2017-04-19 成都先先先生物科技有限公司 一种抗高血压药物复方制剂
CN107501192A (zh) * 2017-08-15 2017-12-22 中国科学院上海药物研究所 替米沙坦与氢***的共晶
CN108653227A (zh) * 2018-08-09 2018-10-16 湖北舒邦药业有限公司 一种替米沙坦氢***片及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994005264A1 (fr) * 1992-09-01 1994-03-17 Boehringer Mannheim Gmbh Comprime oblong secable
WO2003059327A1 (fr) * 2002-01-16 2003-07-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Comprime pharmaceutique bicouche comprenant du telmisartane et un diuretique et preparation dudit comprime

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994005264A1 (fr) * 1992-09-01 1994-03-17 Boehringer Mannheim Gmbh Comprime oblong secable
WO2003059327A1 (fr) * 2002-01-16 2003-07-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Comprime pharmaceutique bicouche comprenant du telmisartane et un diuretique et preparation dudit comprime

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Micardis HCT (telmisartan and hydrochlorothiazide) Tablets, 40mg/12.5 mg 80 mg/12.5 mg and 80 mg/25 mg", BOEHRINGER INGELHEIM, 19 April 2004 (2004-04-19), XP002365096, Retrieved from the Internet <URL:http://www.fda.gov/medwatch/SAFETY/2004/apr_PI/MicardisHCT_PI.pdf> [retrieved on 20060130] *
FREYTAG FRANK ET AL: "Long-term exposure to telmisartan as monotherapy or combination therapy: Efficacy and safety", BLOOD PRESSURE, vol. 11, no. 3, 2002, pages 173 - 181, XP009060475, ISSN: 0803-7051 *
NEUTEL JOEL M ET AL: "Long-term efficacy and tolerability of telmisartan as monotherapy and in combination with other antihypertensive medications.", BLOOD PRESSURE. 2002, vol. 11, no. 5, 2002, pages 302 - 309, XP009060476, ISSN: 0803-7051 *
RAM C VENTIKA S: "Antihypertensive efficacy of angiotensin receptor blockers in combination with hydrochlorothiazide: a review of the factorial-design studies.", JOURNAL OF CLINICAL HYPERTENSION (GREENWICH, CONN.) OCT 2004, vol. 6, no. 10, October 2004 (2004-10-01), pages 569 - 577, XP009060495, ISSN: 1524-6175 *
WHITE W ET AL: "Telmisartan plus hydrochlorothiazide (80/25 mg) has a greater antihypertensive effect than valsartan plus hydrochlorothiazide (160/25 mg) in patients with stage 1 and 2 hypertension", AMERICAN JOURNAL OF HYPERTENSION, ELSEVIER, vol. 18, no. 5, May 2005 (2005-05-01), pages A97, XP004895902, ISSN: 0895-7061 *
WHITE WILLIAM B ET AL: "Effects of the angiotensin II receptor blockers telmisartan versus valsartan on the circadian variation of blood pressure Impact on the early morning period", AMERICAN JOURNAL OF HYPERTENSION, vol. 17, no. 4, April 2004 (2004-04-01), pages 347 - 353, XP002365097, ISSN: 0895-7061 *

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7867991B2 (en) 2002-08-10 2011-01-11 Bethesda Pharmaceuticals, Inc. Compositions comprising novel PPAR ligands and anti-hyperlipemic agents
US7812046B2 (en) 2002-08-10 2010-10-12 Bethesda Pharmaceuticals, Inc. PPAR ligands that do not cause fluid retention, edema or congestive heart failure
WO2007060170A3 (fr) * 2005-11-24 2007-09-13 Boehringer Ingelheim Int Comprimé bicouche comprenant du telmisartan et un diurétique
WO2007060170A2 (fr) * 2005-11-24 2007-05-31 Boehringer Ingelheim International Gmbh Comprimé bicouche comprenant du telmisartan et un diurétique
US8637078B2 (en) 2005-11-24 2014-01-28 Boehringer Ingelheim International Gmbh Bilayer tablet comprising telmisartan and diuretic
US20100143465A1 (en) * 2007-03-14 2010-06-10 Boehringer Ingelheim International Gmbh Pharmaceutical composition
JP2010530844A (ja) * 2007-03-14 2010-09-16 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 医薬組成物
EP2180882B2 (fr) † 2007-10-19 2017-06-28 Otsuka Pharmaceutical Co., Ltd. Préparation pharmaceutique à matrice solide
US9289389B2 (en) 2007-10-19 2016-03-22 Otsuka Pharmaceutical Co., Ltd. Method for producing matrix-type pharmaceutical solid preparation
US9072670B2 (en) * 2007-10-19 2015-07-07 Otsuka Pharmaceutical Co., Ltd. Matrix-type pharmaceutical solid preparation
US20100233265A1 (en) * 2007-10-19 2010-09-16 Kai Suzuki Matrix-type pharmaceutical solid preparation
US20150150806A1 (en) * 2007-10-19 2015-06-04 Otsuka Pharmaceutical Co., Ltd. Method for producing matrix-type pharmaceutical solid preparation
EP2203158A2 (fr) 2007-10-30 2010-07-07 Dr. Reddy's Laboratories, Ltd. Formulations pharmaceutiques comprenant du telmisartan et de l'hydrochlorotiazide
EP2252273A1 (fr) 2008-03-19 2010-11-24 Ratiopharm GmbH Composition pharmaceutique solide incluant un antagoniste non peptidique du récepteur de l angiotensine ii et un diurétique
EP2252273B1 (fr) * 2008-03-19 2016-12-28 ratiopharm GmbH Composition pharmaceutique solide incluant un antagoniste non peptidique du récepteur de l'angiotensine ii et un diurétique
WO2010013835A3 (fr) * 2008-07-31 2010-06-10 Takeda Pharmaceutical Company Limited Composition pharmaceutique solide
US9169238B2 (en) 2008-07-31 2015-10-27 Takeda Pharmaceutical Company Limited Solid pharmaceutical composition
WO2010013835A2 (fr) * 2008-07-31 2010-02-04 Takeda Pharmaceutical Company Limited Composition pharmaceutique solide
WO2010063995A3 (fr) * 2008-12-04 2010-11-25 Arrow International Limited Telmisartan en formulations diurétiques
WO2010063995A2 (fr) * 2008-12-04 2010-06-10 Arrow International Limited Telmisartan en formulations diurétiques
WO2010146187A2 (fr) 2009-06-19 2010-12-23 Krka, Tovarna Zdravil, D.D., Novo Mesto Procédé pour la préparation de telmisartan
WO2011002423A3 (fr) * 2009-07-02 2011-03-03 Mahmut Bilgic Composition pharmaceutique augmentant la solubilité
WO2011002425A3 (fr) * 2009-07-02 2011-03-03 Bilgig Mahmut Composition pharmaceutique présentant une solubilité et une stabilité accrues
WO2011025467A1 (fr) 2009-08-24 2011-03-03 Bilgic Mahmut Formes posologiques solides comprenant du telmisartan
WO2011161123A2 (fr) 2010-06-21 2011-12-29 Krka, Tovarna Zdravil, D.D., Novo Mesto Comprimé pharmaceutique multicouche comprenant du telmisartan et un diurétique
EP2952196A4 (fr) * 2013-01-31 2016-08-03 Sawai Seiyaku Kk Comprimé multicouche contenant du telmisartan et de l'hydrochlorothiazide
US10111858B2 (en) 2013-07-23 2018-10-30 Daiichi Sankyo Company, Limited Pharmaceutical for prophylaxis or treatment of hypertension

Also Published As

Publication number Publication date
PE20060768A1 (es) 2006-09-29
IL183944A0 (en) 2007-10-31
EP1827424A1 (fr) 2007-09-05
CN101080225A (zh) 2007-11-28
TW200637546A (en) 2006-11-01
BRPI0519656A2 (pt) 2009-03-03
AU2005315855A1 (en) 2006-06-22
CA2589493A1 (fr) 2006-06-22
EA200701159A1 (ru) 2007-12-28
AR052052A1 (es) 2007-02-28
KR20070097511A (ko) 2007-10-04
NO20072325L (no) 2007-07-06
JP2008524136A (ja) 2008-07-10
UY29274A1 (es) 2006-07-31

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