WO2011101865A2 - Compositions pharmaceutiques stables de clopidogrel pour administration parentérale - Google Patents

Compositions pharmaceutiques stables de clopidogrel pour administration parentérale Download PDF

Info

Publication number
WO2011101865A2
WO2011101865A2 PCT/IN2011/000098 IN2011000098W WO2011101865A2 WO 2011101865 A2 WO2011101865 A2 WO 2011101865A2 IN 2011000098 W IN2011000098 W IN 2011000098W WO 2011101865 A2 WO2011101865 A2 WO 2011101865A2
Authority
WO
WIPO (PCT)
Prior art keywords
clopidogrel
pharmaceutical composition
injectable pharmaceutical
concentrate
stable injectable
Prior art date
Application number
PCT/IN2011/000098
Other languages
English (en)
Other versions
WO2011101865A3 (fr
Inventor
Sunilendu Bhushan Roy
Sushrut Krishnaji Kulkarni
Maulik Kiritkumar Panchal
Shailendra Shubhashchandra Mandge
Original Assignee
Cadila Healthcare Limited
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 Cadila Healthcare Limited filed Critical Cadila Healthcare Limited
Publication of WO2011101865A2 publication Critical patent/WO2011101865A2/fr
Publication of WO2011101865A3 publication Critical patent/WO2011101865A3/fr

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4365—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D495/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms
    • C07D495/02—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms in which the condensed system contains two hetero rings
    • C07D495/04—Ortho-condensed systems

Abstract

La présente invention concerne des compositions pharmaceutiques stables de clopidogrel ou de sels de celui-ci pour administration parentérale. Elle concerne des compositions pharmaceutiques contenant un concentré de clopidogrel ou des sels de celui-ci pharmaceutiquement acceptables, qui peuvent être mélangés à un véhicule aqueux approprié pour la préparation d'une solution d'infusion convenant à une administration à des patients. Ces compositions présentent une excellente stabilité. L'invention concerne également un procédé de préparation de ces compositions.
PCT/IN2011/000098 2010-02-19 2011-02-17 Compositions pharmaceutiques stables de clopidogrel pour administration parentérale WO2011101865A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN465MU2010 2010-02-19
IN465/MUM/2010 2010-02-19

Publications (2)

Publication Number Publication Date
WO2011101865A2 true WO2011101865A2 (fr) 2011-08-25
WO2011101865A3 WO2011101865A3 (fr) 2011-10-27

Family

ID=44454050

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2011/000098 WO2011101865A2 (fr) 2010-02-19 2011-02-17 Compositions pharmaceutiques stables de clopidogrel pour administration parentérale

Country Status (1)

Country Link
WO (1) WO2011101865A2 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0099802A1 (fr) 1982-07-13 1984-02-01 Elf Sanofi Nouveaux dérivés de la thiéno-(3,2-c) pyridine, leur procédé de préparation et leur application thérapeutique
US4847265A (en) 1987-02-17 1989-07-11 Sanofi Dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate and the pharmaceutical compositions containing it
EP1105102A1 (fr) 1998-08-20 2001-06-13 Sanofi-Synthelabo Composition pharmaceutique injectable a base d'un sel pharmaceutiquement acceptable du clopidogrel ou de ticlopidine
US6284277B1 (en) 1995-11-03 2001-09-04 Sanofi-Synthelabo Stable freeze-dried pharmaceutical formulation
WO2008034600A1 (fr) 2006-09-21 2008-03-27 Novartis Ag Derives de pyrrole utilises dans le traitement des maladies induites par les cytokines
WO2009033455A1 (fr) 2007-09-13 2009-03-19 Grenzebach Maschinenbau Gmbh Dispositif et procédé de séparation d'une bande de verre continue

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100562309C (zh) * 2006-07-14 2009-11-25 北京赛科药业有限责任公司 氯吡格雷及其盐的可注射组合物与其制备方法
US20100062066A1 (en) * 2006-11-14 2010-03-11 Acusphere, Inc Formulations of Tetrahydropyridine Antiplatelet Agents for Parenteral or Oral Administration
DK2152078T3 (da) * 2007-04-27 2021-02-08 Cydex Pharmaceuticals Inc Formuleringer indeholdende clopidogrel og sulfoalkylethercyclodextrin og anvendelsesfremgangsmåder
WO2009133455A2 (fr) * 2008-05-01 2009-11-05 Cadila Healthcare Limited Composition pharmaceutique de clopidogrel

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0099802A1 (fr) 1982-07-13 1984-02-01 Elf Sanofi Nouveaux dérivés de la thiéno-(3,2-c) pyridine, leur procédé de préparation et leur application thérapeutique
US4847265A (en) 1987-02-17 1989-07-11 Sanofi Dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate and the pharmaceutical compositions containing it
US6284277B1 (en) 1995-11-03 2001-09-04 Sanofi-Synthelabo Stable freeze-dried pharmaceutical formulation
EP1105102A1 (fr) 1998-08-20 2001-06-13 Sanofi-Synthelabo Composition pharmaceutique injectable a base d'un sel pharmaceutiquement acceptable du clopidogrel ou de ticlopidine
WO2008034600A1 (fr) 2006-09-21 2008-03-27 Novartis Ag Derives de pyrrole utilises dans le traitement des maladies induites par les cytokines
WO2009033455A1 (fr) 2007-09-13 2009-03-19 Grenzebach Maschinenbau Gmbh Dispositif et procédé de séparation d'une bande de verre continue

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
A. N. MARTIN, J. SWARBRICK, A. CAMMARATA: "Physical Pharmacy", LEE AND FABIGER, pages: 237

Also Published As

Publication number Publication date
WO2011101865A3 (fr) 2011-10-27

Similar Documents

Publication Publication Date Title
JP4972750B2 (ja) 非経口抗真菌生成物
US20170224789A1 (en) Stable injectable composition of bivalirudin and process for its preparation
AU2015256331B2 (en) Formulations of Cyclophosphamide liquid concentrate
JP2018528242A (ja) 非プロトン性極性溶媒中の安定な治療用グルカゴン製剤を製造するための方法
MXPA05002561A (es) Nuevas formulaciones de liberacion prolongada inyectables.
KR102656841B1 (ko) 레파뮬린의 주사가능한 약제학적 제형
JP2018531268A (ja) ダントロレンを含む水性組成物
JP2018531268A6 (ja) ダントロレンを含む水性組成物
JP2012167132A (ja) Ｎ−［ｏ−（ｐ−ピバロイルオキシベンゼンスルホニルアミノ）ベンゾイル］グリシン・モノナトリウム塩・４水和物の凍結乾燥製剤
CA2410446C (fr) Formulation d'esmolol
CN102342931B (zh) 替莫唑胺的可注射的胃肠外用药物制剂及其制备方法
JP2015526463A (ja) 改善されたダプトマイシン注射用製剤
JP2002508330A (ja) ダルホプリスチンおよびキヌプリスチンに基づく医薬組成物ならびに調製
WO2009133455A2 (fr) Composition pharmaceutique de clopidogrel
WO2011101865A2 (fr) Compositions pharmaceutiques stables de clopidogrel pour administration parentérale
US20230068866A1 (en) Daptomycin formulation
US11957758B2 (en) Pharmaceutical composition of docetaxel conjugate and preparation method
JP2015520142A (ja) 非経口エスモロール製剤
WO2023214433A1 (fr) Compositions parentérales stables de parécoxib
WO2023209731A1 (fr) Formes posologiques injectables liquides ou lyophilisées de sélexipag et leur procédé de préparation
EP2976063A1 (fr) Préparation parentérale d'agent antibactérien à base de fluoroquinolone et procédé de préparation associé
WO2016079749A2 (fr) Procédé de préparation de formulation parentérale d'anidulafungine
KR20240056643A (ko) 양극성 용매에서 안정한 치료 제형들의 제조방법
EA023081B1 (ru) Инъекционная лекарственная форма флупиртина

Legal Events

Date Code Title Description
DPE2 Request for preliminary examination filed before expiration of 19th month from priority date (pct application filed from 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 11725819

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 11725819

Country of ref document: EP

Kind code of ref document: A2