WO2008062435A3 - Formes galéniques stabilisées de bésylate d'amlodipine - Google Patents

Formes galéniques stabilisées de bésylate d'amlodipine Download PDF

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Publication number
WO2008062435A3
WO2008062435A3 PCT/IN2007/000385 IN2007000385W WO2008062435A3 WO 2008062435 A3 WO2008062435 A3 WO 2008062435A3 IN 2007000385 W IN2007000385 W IN 2007000385W WO 2008062435 A3 WO2008062435 A3 WO 2008062435A3
Authority
WO
WIPO (PCT)
Prior art keywords
amlodipine besylate
dosage forms
stabilised
methyl
stabilised dosage
Prior art date
Application number
PCT/IN2007/000385
Other languages
English (en)
Other versions
WO2008062435A2 (fr
Inventor
Sandeep G Datarkar
Mavuleti Krishna Prasad
Vemula Sathya Narayana
Samprada Singh
Original Assignee
Alkem Lab Ltd
Sandeep G Datarkar
Mavuleti Krishna Prasad
Vemula Sathya Narayana
Samprada Singh
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 Alkem Lab Ltd, Sandeep G Datarkar, Mavuleti Krishna Prasad, Vemula Sathya Narayana, Samprada Singh filed Critical Alkem Lab Ltd
Publication of WO2008062435A2 publication Critical patent/WO2008062435A2/fr
Publication of WO2008062435A3 publication Critical patent/WO2008062435A3/fr

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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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une forme galénique solide stable comprenant de 2 à 20 % en poids de bésylate d'amlodipine, de 10 à 70 % en poids de polyols et au moins un excipient pharmaceutique connu ayant des niveaux d'impureté D ({3-éthyl-5-méthyl-2-[(2-aminoéthoxy)-méthyl]-4-(2-chlorophényl)-6-méthylpyridine-3,5-dicarboxylate}) inférieurs à 0,5 %.
PCT/IN2007/000385 2006-08-15 2007-08-27 Formes galéniques stabilisées de bésylate d'amlodipine WO2008062435A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN944MU2006 2006-08-15
IN944/MUM/2006 2006-08-15

Publications (2)

Publication Number Publication Date
WO2008062435A2 WO2008062435A2 (fr) 2008-05-29
WO2008062435A3 true WO2008062435A3 (fr) 2008-07-31

Family

ID=39430164

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2007/000385 WO2008062435A2 (fr) 2006-08-15 2007-08-27 Formes galéniques stabilisées de bésylate d'amlodipine

Country Status (1)

Country Link
WO (1) WO2008062435A2 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2363964B1 (es) 2009-11-20 2012-08-22 Gp Pharm, S.A. Cápsulas de principios activos farmacéuticos y ésteres de ácidos grasos poliinsaturados.
CA2904416A1 (fr) 2013-03-07 2014-09-12 Amneal Pharmaceuticals, LLC Stabilisation de medicaments sensibles a l'humidite
WO2016155815A1 (fr) 2015-04-01 2016-10-06 Ceva Sante Animale Forme posologique orale solide d'amlodipine et usages vétérinaires correspondants
US10350171B2 (en) 2017-07-06 2019-07-16 Dexcel Ltd. Celecoxib and amlodipine formulation and method of making the same
CN112162047B (zh) * 2020-09-25 2022-08-02 宁波大红鹰药业股份有限公司 一种苯磺酸氨氯地平中基因毒性杂质含量的测定方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993010779A1 (fr) * 1991-11-26 1993-06-10 Sepracor, Inc. Procedes et compositions destines a traiter l'hypertension, l'angine de poitrine et d'autres troubles a l'aide de (-)amlodipine optiquement pure
CN1546024A (zh) * 2003-12-09 2004-11-17 成都圣诺科技发展有限公司 苯磺酸氨氯地平口腔崩解片及其制备方法
WO2005032553A1 (fr) * 2003-10-08 2005-04-14 Yuhan Corporation Composition pour comprime a desintegration rapide comprenant une base libre d'amlodipine
CN1686121A (zh) * 2005-04-19 2005-10-26 昆明金殿制药有限公司 苯磺酸氨氯地平分散片及其制备方法
WO2006118210A1 (fr) * 2005-04-28 2006-11-09 Eisai R & D Management Co., Ltd. Procede de prevention de la degradation d'un compose dihydropyridine
JP2008013489A (ja) * 2006-07-06 2008-01-24 Ohara Yakuhin Kogyo Kk ベシル酸アムロジピン含有錠剤

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993010779A1 (fr) * 1991-11-26 1993-06-10 Sepracor, Inc. Procedes et compositions destines a traiter l'hypertension, l'angine de poitrine et d'autres troubles a l'aide de (-)amlodipine optiquement pure
WO2005032553A1 (fr) * 2003-10-08 2005-04-14 Yuhan Corporation Composition pour comprime a desintegration rapide comprenant une base libre d'amlodipine
CN1546024A (zh) * 2003-12-09 2004-11-17 成都圣诺科技发展有限公司 苯磺酸氨氯地平口腔崩解片及其制备方法
CN1686121A (zh) * 2005-04-19 2005-10-26 昆明金殿制药有限公司 苯磺酸氨氯地平分散片及其制备方法
WO2006118210A1 (fr) * 2005-04-28 2006-11-09 Eisai R & D Management Co., Ltd. Procede de prevention de la degradation d'un compose dihydropyridine
JP2008013489A (ja) * 2006-07-06 2008-01-24 Ohara Yakuhin Kogyo Kk ベシル酸アムロジピン含有錠剤

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 200682, Derwent World Patents Index; AN 2006-815228 *
DATABASE WPI Week 200821, Derwent World Patents Index; AN 2008-C89465 *

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