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EP2349215A1 - Comprimés contenant du valsartan - Google Patents

Comprimés contenant du valsartan

Info

Publication number
EP2349215A1
EP2349215A1 EP09736570A EP09736570A EP2349215A1 EP 2349215 A1 EP2349215 A1 EP 2349215A1 EP 09736570 A EP09736570 A EP 09736570A EP 09736570 A EP09736570 A EP 09736570A EP 2349215 A1 EP2349215 A1 EP 2349215A1
Authority
EP
European Patent Office
Prior art keywords
valsartan
active ingredient
pharmaceutically acceptable
acceptable salt
powder
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.)
Withdrawn
Application number
EP09736570A
Other languages
German (de)
English (en)
Inventor
Peng Junqing
Zhou Shilin
Gao Huiyan
Hu Gongyun
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.)
Zhejiang Huahai Pharmaceutical Co Ltd
Alfred E Tiefenbacher GmbH and Co KG
Original Assignee
Zhejiang Huahai Pharmaceutical Co Ltd
Alfred E Tiefenbacher GmbH and 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
Application filed by Zhejiang Huahai Pharmaceutical Co Ltd, Alfred E Tiefenbacher GmbH and Co KG filed Critical Zhejiang Huahai Pharmaceutical Co Ltd
Publication of EP2349215A1 publication Critical patent/EP2349215A1/fr
Withdrawn legal-status Critical Current

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
    • A61K9/48—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
    • 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
    • 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
    • A61K31/549—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 having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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

Definitions

  • Sodium starch glycolate, microcrystalline cellulose and low substituted sodium carboxymethyl cellulose and the like As a lubricant for improving the flow properties or the flowability, in particular highly disperse silica, z.
  • a colloidal, anhydrous silicic acid, magnesium trisilicate, cellulose powder, talc, tricalcium phosphate and the like can be used.
  • stearic acid, magnesium stearate, polyethylene glycol (PEG 4000-8000), talc and the like can be used particularly.
  • the present invention relates to a drug granules consisting solely of valsartan or a pharmaceutically acceptable salt thereof and optionally another active ingredient.
  • This active ingredient granules is an intermediate in the preparation of a valsartan-containing tablet according to the method of the invention.
  • the valsart granules were obtained by roll compaction of the active ingredient powder and subsequent granulation of the resulting slugs.
  • Example 5 The ingredients of the tabletting mixture except for the magnesium stearate were mixed. The resulting mixture was then treated with magnesium stearate. The tableting mixture thus obtained was mixed and pressed into a tablet core. The tablet core was then film-coated.
  • Example 5 The ingredients of the tabletting mixture except for the magnesium stearate were mixed. The resulting mixture was then treated with magnesium stearate. The tableting mixture thus obtained was mixed and pressed into a tablet core. The tablet core was then film-coated.
  • Valsartan and hydrochlorothiazide each in powder form, were mixed.
  • the active ingredient granules consisting of valsartan and hydrochlorothiazide were obtained by roll compaction of the abovementioned powder mixture and subsequent granulation of the resulting slugs.

Landscapes

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

Abstract

La présente invention concerne un procédé de fabrication d'un comprimé contenant du valsartan ainsi qu'un granulat de substance active qui est constitué exclusivement de valsartan ou d'un sel pharmaceutiquement acceptable de celui-ci et éventuellement d'une autre substance active, et son utilisation dans la fabrication du comprimé.
EP09736570A 2008-10-17 2009-10-13 Comprimés contenant du valsartan Withdrawn EP2349215A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200810051783 DE102008051783A1 (de) 2008-10-17 2008-10-17 Valsartan enthaltende Tablette
PCT/EP2009/007347 WO2010043376A1 (fr) 2008-10-17 2009-10-13 Comprimés contenant du valsartan

Publications (1)

Publication Number Publication Date
EP2349215A1 true EP2349215A1 (fr) 2011-08-03

Family

ID=41511125

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09736570A Withdrawn EP2349215A1 (fr) 2008-10-17 2009-10-13 Comprimés contenant du valsartan

Country Status (3)

Country Link
EP (1) EP2349215A1 (fr)
DE (1) DE102008051783A1 (fr)
WO (1) WO2010043376A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200276129A1 (en) * 2017-10-13 2020-09-03 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Tablet containing valsartan and sacubitril

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9415048D0 (en) * 1994-07-26 1994-09-14 Leo Pharm Prod Ltd Tablet
GB9613470D0 (en) 1996-06-27 1996-08-28 Ciba Geigy Ag Small solid oral dosage form
US20080020042A1 (en) * 2003-10-14 2008-01-24 Peter Gruber Dosage form of sodium ibuprofen
WO2005082329A2 (fr) * 2004-02-19 2005-09-09 Ranbaxy Laboratories Limited Procede de preparation de formes posologiques solides de valsartan et d'hydrochlorthiazide
EP1674080A1 (fr) * 2004-12-24 2006-06-28 KRKA, D.D., Novo Mesto Composition pharmaceutique comprenant du valsartan
ES2334933T3 (es) * 2005-08-15 2010-03-17 Siegfried Generics International Ag Comprimido recubierto o granulado que contiene una piridilpirimidina.
GT200600371A (es) * 2005-08-17 2007-03-21 Formas de dosis sólidas de valsartan y amlodipina y método para hacer las mismas
DE102005054610B4 (de) * 2005-11-08 2010-06-10 Awd.Pharma Gmbh & Co. Kg Flupirtin enthaltende Arzneimittelzubereitung mit kontrollierter Wirkstofffreisetzung
WO2008064338A2 (fr) * 2006-11-22 2008-05-29 Rubicon Research Pvt. Ltd. Formulation de valsartan pour administration pulsatile

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2010043376A1 *

Also Published As

Publication number Publication date
DE102008051783A1 (de) 2010-04-22
WO2010043376A1 (fr) 2010-04-22

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Legal Events

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