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WO2010063997A1 - Formulations de telmisartan - Google Patents

Formulations de telmisartan Download PDF

Info

Publication number
WO2010063997A1
WO2010063997A1 PCT/GB2009/002793 GB2009002793W WO2010063997A1 WO 2010063997 A1 WO2010063997 A1 WO 2010063997A1 GB 2009002793 W GB2009002793 W GB 2009002793W WO 2010063997 A1 WO2010063997 A1 WO 2010063997A1
Authority
WO
WIPO (PCT)
Prior art keywords
telmisartan
formulation
weight
formulation according
formulations
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/GB2009/002793
Other languages
English (en)
Inventor
Peter Henry Robert Persicaner
Rahul Sareen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arrow International Ltd
Original Assignee
Arrow International Ltd
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 Arrow International Ltd filed Critical Arrow International Ltd
Publication of WO2010063997A1 publication Critical patent/WO2010063997A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Definitions

  • the present invention relates to pharmaceutical tablet formulations of the angiotensin Il receptor antagonist telmisartan.
  • Formulations of the invention are characterised by high levels of water soluble diluents, and preferred formulations of the invention comprise in excess of 65% by weight water soluble diluents, more preferably in excess of 70% by weight water soluble diluents, even more preferably in excess of 72% by weight water soluble diluents.
  • the diluents may be one or a mixture of diluents, and generally, the amount of diluents should not exceed an upper limit of about 90% by weight, or 80% by weight.
  • a binder may be selected depending on the manufacturing process chosen for the pharmaceutical composition. Suitable dry binders include cellulose powder, crystalline cellulose and silicified microcrystalline cellulose. Examples of wet granulation binders are corn starch, polyvinyl pyrrolidone (Povidone), vinylpyrrolidone-vinylacetate copolymer (Copovidone) and cellulose derivatives such as hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropyl-cellulose and hydroxypropylmethylcellulose.
  • Povidone Preferred formulations of telmisartan comprise 0-15% by weight binder, more preferably 2-10% by weight binder.
  • the telmisartan-containing formulation is a dissolving formulation.
  • Magnesium stearate 1.54 In this formulation, sodium hydroxide acts as a basifying agent, Povidone K-30 acts as a binder, purified water acts as a granulation aid, mannitol acts as a water- soluble filler and magnesium stearate acts as a lubricant.
  • the screened granules were blended with 800 g magnesium stearate using a suitable blender.

Landscapes

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

Abstract

La présente invention concerne un comprimé de telmisartan qui est formulé avec 60 % ou plus de diluant hydrosoluble, sans nécessiter un tensioactif ou un agent de solubilisation d’acide aminé basique.
PCT/GB2009/002793 2008-12-04 2009-12-01 Formulations de telmisartan Ceased WO2010063997A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0822171.5 2008-12-04
GB0822171A GB0822171D0 (en) 2008-12-04 2008-12-04 Temisartan formulations

Publications (1)

Publication Number Publication Date
WO2010063997A1 true WO2010063997A1 (fr) 2010-06-10

Family

ID=40289507

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2009/002793 Ceased WO2010063997A1 (fr) 2008-12-04 2009-12-01 Formulations de telmisartan

Country Status (2)

Country Link
GB (1) GB0822171D0 (fr)
WO (1) WO2010063997A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113116835A (zh) * 2021-05-11 2021-07-16 南京双科医药开发有限公司 一种替米沙坦片的制备方法

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000027396A1 (fr) * 1998-11-06 2000-05-18 Glaxo Group Limited Medicaments a base de combinaisons de lacidipine et de telmisartan ou de derives physiologiques
US20050004107A1 (en) * 2003-04-30 2005-01-06 Boehringer Ingelheim International Gmbh Telmisartan sodium salt pharmaceutical formulation
WO2006108506A1 (fr) * 2005-04-09 2006-10-19 Bayer Healthcare Ag Nouvelles utilisations de derives d'imidazotriazinone 2-phenyl-substitues pour traiter une hypertonie pulmonaire
EP1970053A1 (fr) * 2007-03-14 2008-09-17 Boehringer Ingelheim Pharma GmbH & Co. KG Composition pharmaceutique
WO2009058950A2 (fr) * 2007-10-30 2009-05-07 Dr. Reddy's Laboratories Ltd. Formulations pharmaceutiques comprenant du telmisartan et de l'hydrochlorotiazide
WO2009115301A1 (fr) * 2008-03-19 2009-09-24 Ratiopharm Gmbh Composition pharmaceutique solide incluant un antagoniste non peptidique du récepteur de l’angiotensine ii et un diurétique
WO2009135646A2 (fr) * 2008-05-05 2009-11-12 Farmaprojects, Sa Compositions pharmaceutiques stables et procédés de préparation desdites compositions adaptés à l’échelle industrielle
WO2010012248A1 (fr) * 2008-07-31 2010-02-04 Zentiva, K.S. Comprimés de telmisartan

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000027396A1 (fr) * 1998-11-06 2000-05-18 Glaxo Group Limited Medicaments a base de combinaisons de lacidipine et de telmisartan ou de derives physiologiques
US20050004107A1 (en) * 2003-04-30 2005-01-06 Boehringer Ingelheim International Gmbh Telmisartan sodium salt pharmaceutical formulation
WO2006108506A1 (fr) * 2005-04-09 2006-10-19 Bayer Healthcare Ag Nouvelles utilisations de derives d'imidazotriazinone 2-phenyl-substitues pour traiter une hypertonie pulmonaire
EP1970053A1 (fr) * 2007-03-14 2008-09-17 Boehringer Ingelheim Pharma GmbH & Co. KG Composition pharmaceutique
WO2009058950A2 (fr) * 2007-10-30 2009-05-07 Dr. Reddy's Laboratories Ltd. Formulations pharmaceutiques comprenant du telmisartan et de l'hydrochlorotiazide
WO2009115301A1 (fr) * 2008-03-19 2009-09-24 Ratiopharm Gmbh Composition pharmaceutique solide incluant un antagoniste non peptidique du récepteur de l’angiotensine ii et un diurétique
WO2009135646A2 (fr) * 2008-05-05 2009-11-12 Farmaprojects, Sa Compositions pharmaceutiques stables et procédés de préparation desdites compositions adaptés à l’échelle industrielle
WO2010012248A1 (fr) * 2008-07-31 2010-02-04 Zentiva, K.S. Comprimés de telmisartan

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113116835A (zh) * 2021-05-11 2021-07-16 南京双科医药开发有限公司 一种替米沙坦片的制备方法

Also Published As

Publication number Publication date
GB0822171D0 (en) 2009-01-14

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