WO2008150245A3 - Stable formulation of amorphous perindopril salts, a process for the preparation thereof on industrial scale and use thereof in the treatment of hypertension - Google Patents

Stable formulation of amorphous perindopril salts, a process for the preparation thereof on industrial scale and use thereof in the treatment of hypertension Download PDF

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Publication number
WO2008150245A3
WO2008150245A3 PCT/SI2008/000031 SI2008000031W WO2008150245A3 WO 2008150245 A3 WO2008150245 A3 WO 2008150245A3 SI 2008000031 W SI2008000031 W SI 2008000031W WO 2008150245 A3 WO2008150245 A3 WO 2008150245A3
Authority
WO
WIPO (PCT)
Prior art keywords
preparation
stable formulation
hypertension
treatment
industrial scale
Prior art date
Application number
PCT/SI2008/000031
Other languages
French (fr)
Other versions
WO2008150245A2 (en
Inventor
Rudolf Rucman
Pavel Zupet
Original Assignee
Silverstone Pharma
Rudolf Rucman
Pavel Zupet
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 Silverstone Pharma, Rudolf Rucman, Pavel Zupet filed Critical Silverstone Pharma
Priority to EP08754036A priority Critical patent/EP2164469A2/en
Priority to CN2008800187504A priority patent/CN101742986B/en
Publication of WO2008150245A2 publication Critical patent/WO2008150245A2/en
Publication of WO2008150245A3 publication Critical patent/WO2008150245A3/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
    • A61K9/14—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
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • 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

Landscapes

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

Abstract

The present invention discloses a preparation of a stable formulation of alkali and alkaline earth salts of perindopril in an amorphous form, wherein perindopril in the form of a free acid, dissolved in alcohol, is neutralized with an aqueous solution of alkali or alkaline earth base, this solution is thereafter sprayed onto inert substances for the preparation of a granulate and dried in a stream of warm air at 30-50 °C or in vacuum. Substances to facilitate tabletting or additional active substances, such as diuretics, preferably indapamide, are added to this granulate to be tabletted.
PCT/SI2008/000031 2007-06-04 2008-05-30 Stable formulation of amorphous perindopril salts, a process for the preparation thereof on industrial scale and use thereof in the treatment of hypertension WO2008150245A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP08754036A EP2164469A2 (en) 2007-06-04 2008-05-30 Stable formulation of amorphous perindopril salts, a process for the preparation thereof on industrial scale and use thereof in the treatment of hypertension
CN2008800187504A CN101742986B (en) 2007-06-04 2008-05-30 Stable formulation of amorphous perindopril salts, a process for the preparation thereof on industrial scale and use thereof in the treatment of hypertension

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SI200700131A SI22542A (en) 2007-06-04 2007-06-04 Stable formulation of amorphous salts of perindopril, procedure for its preparation in industrial scale and its application for treatmentof hypertensia
SIP-200700131 2007-06-04

Publications (2)

Publication Number Publication Date
WO2008150245A2 WO2008150245A2 (en) 2008-12-11
WO2008150245A3 true WO2008150245A3 (en) 2009-02-05

Family

ID=39930588

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SI2008/000031 WO2008150245A2 (en) 2007-06-04 2008-05-30 Stable formulation of amorphous perindopril salts, a process for the preparation thereof on industrial scale and use thereof in the treatment of hypertension

Country Status (5)

Country Link
EP (1) EP2164469A2 (en)
CN (1) CN101742986B (en)
RU (1) RU2464022C2 (en)
SI (1) SI22542A (en)
WO (1) WO2008150245A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2013201812B2 (en) * 2007-06-27 2015-04-02 Les Laboratoires Servier Salts of perindopril
SI22543A (en) * 2007-06-27 2008-12-31 Krka, Tovarna Zdravil, D.D., Novo Mesto New salts of perindopril
SI23149A (en) 2009-09-21 2011-03-31 Silverstone Pharma New benzatin salts of ace inhibitors, procedure for their preparationand their application for treatment of cardiovascular diseases

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005068425A1 (en) * 2004-01-14 2005-07-28 Lek Pharmaceuticals D.D. New crystalline form of perindopril
WO2005068490A1 (en) * 2004-01-14 2005-07-28 Lek Pharmaceuticals D.D. Inclusion complexes of perindopril
WO2007058634A1 (en) * 2005-11-17 2007-05-24 Diagen Smartno Pri Ljubljani, D.O.O. Stable formulation of amorphous perindopril salts, a process for their preparation, especially industrial preparation, and their use in the therapy of hypertension

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2838648B1 (en) * 2002-04-18 2004-05-21 Servier Lab NEW PERINDOPRIL SALT AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING IT

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005068425A1 (en) * 2004-01-14 2005-07-28 Lek Pharmaceuticals D.D. New crystalline form of perindopril
WO2005068490A1 (en) * 2004-01-14 2005-07-28 Lek Pharmaceuticals D.D. Inclusion complexes of perindopril
WO2007058634A1 (en) * 2005-11-17 2007-05-24 Diagen Smartno Pri Ljubljani, D.O.O. Stable formulation of amorphous perindopril salts, a process for their preparation, especially industrial preparation, and their use in the therapy of hypertension

Also Published As

Publication number Publication date
WO2008150245A2 (en) 2008-12-11
EP2164469A2 (en) 2010-03-24
CN101742986A (en) 2010-06-16
RU2009149675A (en) 2011-07-20
CN101742986B (en) 2013-07-17
RU2464022C2 (en) 2012-10-20
SI22542A (en) 2008-12-31

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