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WO2008068777A3 - Stable lercanidipine formulation - Google Patents

Stable lercanidipine formulation Download PDF

Info

Publication number
WO2008068777A3
WO2008068777A3 PCT/IN2007/000585 IN2007000585W WO2008068777A3 WO 2008068777 A3 WO2008068777 A3 WO 2008068777A3 IN 2007000585 W IN2007000585 W IN 2007000585W WO 2008068777 A3 WO2008068777 A3 WO 2008068777A3
Authority
WO
WIPO (PCT)
Prior art keywords
lercanidipine
stable
adsorbates
formulation
lercanidipine formulation
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/IN2007/000585
Other languages
French (fr)
Other versions
WO2008068777A2 (en
Inventor
Jyothi Lakshmi Gunupati
Nagesh Nanda
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.)
Torrent Pharmaceuticals Ltd
Original Assignee
Torrent Pharmaceuticals 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 Torrent Pharmaceuticals Ltd filed Critical Torrent Pharmaceuticals Ltd
Priority to EP07870544A priority Critical patent/EP2101771A2/en
Publication of WO2008068777A2 publication Critical patent/WO2008068777A2/en
Publication of WO2008068777A3 publication Critical patent/WO2008068777A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

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

Abstract

The present invention relates to stable solid oral dosage form of lercanidipine by using a process of preparation of adsorbates. The invention further relates to lercanidipine adsorbates that are obtainable by said process, as well as pharmaceutical formulations prepared while employing said lercanidipine adsorbates.
PCT/IN2007/000585 2006-12-06 2007-12-05 Stable lercanidipine formulation Ceased WO2008068777A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07870544A EP2101771A2 (en) 2006-12-06 2007-12-05 Stable lercanidipine formulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2004/MUM/2006 2006-12-06
IN2004MU2006 2006-12-06

Publications (2)

Publication Number Publication Date
WO2008068777A2 WO2008068777A2 (en) 2008-06-12
WO2008068777A3 true WO2008068777A3 (en) 2008-12-31

Family

ID=39363963

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2007/000585 Ceased WO2008068777A2 (en) 2006-12-06 2007-12-05 Stable lercanidipine formulation

Country Status (2)

Country Link
EP (1) EP2101771A2 (en)
WO (1) WO2008068777A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA97161C2 (en) * 2007-07-23 2012-01-10 Фарматен С.А. Normal;heading 1;heading 2;heading 3;PHARMACEUTICAL COMPOSITION CONTAINING DIHYDROPYRIDINE CALCIUM CHANNEL ANTAGONIST AND METHOD FOR THE PREPARATION THEREOF
WO2011161223A2 (en) 2010-06-23 2011-12-29 Krka, Tovarna Zdravil, D.D., Novo Mesto Pharmaceutical oral dosage forms comprising lercanidipine and enalapril and their pharmaceutically acceptable salts
WO2012085249A2 (en) 2010-12-24 2012-06-28 Krka, D.D., Novo Mesto Homogenous pharmaceutical oral dosage forms comprising lercanidipine and enalapril or their pharmaceutically acceptable salts

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5266581A (en) * 1984-07-04 1993-11-30 Bayer Aktiengesellschaft Solid composition containing dihydropyridine, PVP and PVPP
US20060134212A1 (en) * 2004-09-02 2006-06-22 Forest Laboratories, Inc. Lercanidipine immediate release compositions
US20060211742A1 (en) * 2005-02-25 2006-09-21 Recordati Ireland Limited Amorphous lercanidipine hydrochloride and uses thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5266581A (en) * 1984-07-04 1993-11-30 Bayer Aktiengesellschaft Solid composition containing dihydropyridine, PVP and PVPP
US20060134212A1 (en) * 2004-09-02 2006-06-22 Forest Laboratories, Inc. Lercanidipine immediate release compositions
US20060211742A1 (en) * 2005-02-25 2006-09-21 Recordati Ireland Limited Amorphous lercanidipine hydrochloride and uses thereof

Also Published As

Publication number Publication date
WO2008068777A2 (en) 2008-06-12
EP2101771A2 (en) 2009-09-23

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