RU2012122654A - STABLE PHARMACEUTICAL INJECTION ACECLOFENAC COMPOSITION AND METHOD FOR PRODUCING IT - Google Patents

STABLE PHARMACEUTICAL INJECTION ACECLOFENAC COMPOSITION AND METHOD FOR PRODUCING IT Download PDF

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Publication number
RU2012122654A
RU2012122654A RU2012122654/15A RU2012122654A RU2012122654A RU 2012122654 A RU2012122654 A RU 2012122654A RU 2012122654/15 A RU2012122654/15 A RU 2012122654/15A RU 2012122654 A RU2012122654 A RU 2012122654A RU 2012122654 A RU2012122654 A RU 2012122654A
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RU
Russia
Prior art keywords
arginine
aceclofenac
aqueous solution
stable pharmaceutical
solution
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RU2012122654/15A
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Russian (ru)
Inventor
Рампал АШОК
Мехендре РАТНАКАР
Пхадтар ДИПТИ
Сантра СОУМЕН
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Алкем Лабораториз Лтд.
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Publication of RU2012122654A publication Critical patent/RU2012122654A/en

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    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

1. Стабильная фармацевтическая инъекционная композиция, содержащая водный раствор аргинина и ацеклофенака с молярным соотношением аргинина к ацеклофенаку в диапазоне от приблизительно 1,1:1 до приблизительно 3,4:1, имеющий рН от приблизительно 6,5 до приблизительно 8,7, где упомянутый водный раствор лиофилизирован.2. Стабильная фармацевтическая инъекционная композиция по п.1, где водный раствор аргинина и ацеклофенака имеет рН от приблизительно 6,5 до приблизительно 7,5, и где упомянутый водный раствор лиофилизирован.3. Способ получения стабильной фармацевтической инъекционной композиции, содержащей водный раствор аргинина и ацеклофенака с молярным соотношением аргинина к ацеклофенаку в диапазоне от приблизительно 1,1:1 до приблизительно 3,4:1, имеющий рН от приблизительно 6,5 до приблизительно 8,7, предусматривающий:(a) растворение аргинина в воде до образования раствора аргинина и, возможно, смешивание с одним или более фармацевтически приемлемым эксципиентом,(b) растворение ацеклофенака в растворе аргинина стадии (а) до образования водного раствора аргинина и ацеклофенака,(c) регулирование рН раствора стадии (b),(d) лиофилизацию раствора стадии (с),и где упомянутый водный раствор лиофилизирован.4. Способ по п.3, где стабильная фармацевтическая инъекционная композиция, содержащая водный раствор аргинина и ацеклофенака с молярным соотношением аргинина к ацеклофенаку в диапазоне от приблизительно 1,1:1 до приблизительно 3,4:1 имеет рН от приблизительно 6,5 до приблизительно 7,5, и где упомянутый водный раствор лиофилизирован.1. A stable pharmaceutical injection composition containing an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1, having a pH from about 6.5 to about 8.7, where said aqueous solution is lyophilized. 2. A stable pharmaceutical injection composition according to claim 1, wherein the aqueous solution of arginine and aceclofenac has a pH from about 6.5 to about 7.5, and where said aqueous solution is lyophilized. A method of obtaining a stable pharmaceutical injection composition containing an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1, having a pH from about 6.5 to about 8.7, comprising : (a) dissolving arginine in water to form an arginine solution and possibly mixing with one or more pharmaceutically acceptable excipients, (b) dissolving aceclofenac in the arginine solution of step (a) until an aqueous solution of arginine is formed aceclofenac on and, (c) adjusting the pH of the solution of step (b), (d) lyophilizing the solution of step (c), and wherein said aqueous solution liofilizirovan.4. The method of claim 3, wherein the stable pharmaceutical injection composition comprising an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1 has a pH from about 6.5 to about 7 5, and wherein said aqueous solution is lyophilized.

Claims (4)

1. Стабильная фармацевтическая инъекционная композиция, содержащая водный раствор аргинина и ацеклофенака с молярным соотношением аргинина к ацеклофенаку в диапазоне от приблизительно 1,1:1 до приблизительно 3,4:1, имеющий рН от приблизительно 6,5 до приблизительно 8,7, где упомянутый водный раствор лиофилизирован.1. A stable pharmaceutical injection composition containing an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1, having a pH from about 6.5 to about 8.7, where said aqueous solution is lyophilized. 2. Стабильная фармацевтическая инъекционная композиция по п.1, где водный раствор аргинина и ацеклофенака имеет рН от приблизительно 6,5 до приблизительно 7,5, и где упомянутый водный раствор лиофилизирован.2. The stable pharmaceutical injection composition according to claim 1, wherein the aqueous solution of arginine and aceclofenac has a pH from about 6.5 to about 7.5, and wherein said aqueous solution is lyophilized. 3. Способ получения стабильной фармацевтической инъекционной композиции, содержащей водный раствор аргинина и ацеклофенака с молярным соотношением аргинина к ацеклофенаку в диапазоне от приблизительно 1,1:1 до приблизительно 3,4:1, имеющий рН от приблизительно 6,5 до приблизительно 8,7, предусматривающий:3. A method of obtaining a stable pharmaceutical injection composition containing an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1, having a pH from about 6.5 to about 8.7 providing for: (a) растворение аргинина в воде до образования раствора аргинина и, возможно, смешивание с одним или более фармацевтически приемлемым эксципиентом,(a) dissolving arginine in water to form an arginine solution and optionally mixing with one or more pharmaceutically acceptable excipients, (b) растворение ацеклофенака в растворе аргинина стадии (а) до образования водного раствора аргинина и ацеклофенака,(b) dissolving aceclofenac in the arginine solution of step (a) until an aqueous solution of arginine and aceclofenac is formed, (c) регулирование рН раствора стадии (b),(c) adjusting the pH of the solution of step (b), (d) лиофилизацию раствора стадии (с),(d) lyophilization of the solution of step (c), и где упомянутый водный раствор лиофилизирован.and where said aqueous solution is lyophilized. 4. Способ по п.3, где стабильная фармацевтическая инъекционная композиция, содержащая водный раствор аргинина и ацеклофенака с молярным соотношением аргинина к ацеклофенаку в диапазоне от приблизительно 1,1:1 до приблизительно 3,4:1 имеет рН от приблизительно 6,5 до приблизительно 7,5, и где упомянутый водный раствор лиофилизирован. 4. The method according to claim 3, where a stable pharmaceutical injection composition containing an aqueous solution of arginine and aceclofenac with a molar ratio of arginine to aceclofenac in the range from about 1.1: 1 to about 3.4: 1 has a pH from about 6.5 to about 7.5, and wherein said aqueous solution is lyophilized.
RU2012122654/15A 2009-11-05 2010-05-14 STABLE PHARMACEUTICAL INJECTION ACECLOFENAC COMPOSITION AND METHOD FOR PRODUCING IT RU2012122654A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2564/MUM/2009 2009-11-05
IN2564MU2009 2009-11-05
PCT/IN2010/000310 WO2011055379A1 (en) 2009-11-05 2010-05-14 A stable injectable pharmaceutical composition of aceclofenac and process for preparing thereof

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RU2012122654A true RU2012122654A (en) 2013-12-10

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RU (1) RU2012122654A (en)
UA (1) UA103955C2 (en)
WO (1) WO2011055379A1 (en)
ZA (1) ZA201203711B (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX9700210A (en) * 1994-06-29 1998-01-31 Novartis Ag Tambien Denominada New salts of 2-[(2,6-dichlorophenyl)amine]phenylacetoxyacetic acid with organic basic cations.
AU2003270540A1 (en) * 2002-09-11 2004-04-30 Nitromed, Inc. Treatment of cyclooxygenase-3 mediated diseases and disorders
KR100673508B1 (en) * 2003-07-07 2007-02-05 진양제약주식회사 A new aceclofenac amino acid salt and pharmaceutical preparation containing the same as active substance
ES2450648T3 (en) * 2004-06-29 2014-03-25 Takeda Pharma A/S Manufacture of pharmaceutical compositions with rapid release of water insoluble drugs and pharmaceutical compositions obtained by the process of the invention
CN101205193A (en) * 2007-12-14 2008-06-25 王文菊 Salt compound formed by aceclofenac and organic base as well as composition and uses thereof

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UA103955C2 (en) 2013-12-10
ZA201203711B (en) 2013-03-27

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Effective date: 20140418