ATE373489T1 - Injizierbare formulierung mit natriumdiclofenac, beta-cyclodextrin und einem polysorbat - Google Patents

Injizierbare formulierung mit natriumdiclofenac, beta-cyclodextrin und einem polysorbat

Info

Publication number
ATE373489T1
ATE373489T1 AT05105474T AT05105474T ATE373489T1 AT E373489 T1 ATE373489 T1 AT E373489T1 AT 05105474 T AT05105474 T AT 05105474T AT 05105474 T AT05105474 T AT 05105474T AT E373489 T1 ATE373489 T1 AT E373489T1
Authority
AT
Austria
Prior art keywords
polysorbate
cyclodextrin
beta
injectable formulation
sodium diclofenac
Prior art date
Application number
AT05105474T
Other languages
English (en)
Inventor
Giorgio Zoppetti
Nadia Puppini
Marco Pizzutti
Original Assignee
Altergon Sa
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 Altergon Sa filed Critical Altergon Sa
Application granted granted Critical
Publication of ATE373489T1 publication Critical patent/ATE373489T1/de

Links

Classifications

    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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
    • A61K9/08—Solutions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives 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
    • A61K9/0012—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
    • 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]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Nanotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Biochemistry (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AT05105474T 2004-06-22 2005-06-21 Injizierbare formulierung mit natriumdiclofenac, beta-cyclodextrin und einem polysorbat ATE373489T1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT001245A ITMI20041245A1 (it) 2004-06-22 2004-06-22 Composizioni farmaceutiche iniettabnili comprendenti diclofenac sodico e b-ciclodestrina

Publications (1)

Publication Number Publication Date
ATE373489T1 true ATE373489T1 (de) 2007-10-15

Family

ID=35033310

Family Applications (1)

Application Number Title Priority Date Filing Date
AT05105474T ATE373489T1 (de) 2004-06-22 2005-06-21 Injizierbare formulierung mit natriumdiclofenac, beta-cyclodextrin und einem polysorbat

Country Status (13)

Country Link
US (1) US7423028B2 (de)
EP (1) EP1609481B1 (de)
JP (1) JP5113323B2 (de)
KR (1) KR101202649B1 (de)
CN (1) CN100569230C (de)
AT (1) ATE373489T1 (de)
CA (1) CA2510813C (de)
DE (1) DE602005002495T2 (de)
DK (1) DK1609481T3 (de)
ES (1) ES2293482T3 (de)
IT (1) ITMI20041245A1 (de)
PL (1) PL1609481T3 (de)
PT (1) PT1609481E (de)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA013616B1 (ru) 2005-02-01 2010-06-30 Троикаа Фармасьютикалз Лтд. Инъекционные препараты диклофенака и его фармацевтически приемлемых солей
EP2522343A1 (de) 2006-03-28 2012-11-14 Javelin Pharmaceuticals, Inc. Formulierungen aus niedrigdosiertem Diclofenac und Beta-Cyclodextrin
MX2008012496A (es) * 2006-03-28 2009-01-07 Javelin Pharmaceuticals Inc Formulaciones de farmacos anti-inflamatorios no esteroidales de baja dosis y beta-ciclodextrina.
ITMI20121205A1 (it) 2012-07-11 2014-01-12 Glycores 2000 Srl Composizione con attivita' antinfiammatoria ed analgesica da somministrare per uso esterno mediante vaporizzazione
US20140275261A1 (en) 2013-03-15 2014-09-18 Dr. Reddy's Laboratories, Inc. Diclofenac parenteral compositions
CN103432132B (zh) * 2013-08-31 2015-01-21 西南大学 甲磺酸普立地诺双氯芬酸钠注射液及其制备方法
US10525137B2 (en) * 2015-12-30 2020-01-07 Genentech, Inc. Formulations with reduced degradation of polysorbate
CN107126418B (zh) * 2016-02-25 2020-05-29 江苏思邈医药科技有限公司 供注射用双氯芬酸钠药物组合物及其制备方法
EP3216443A1 (de) 2016-03-10 2017-09-13 Athenion AG Kapsel zur getränkevorbereitung aus einem solubilisat
IT201600075246A1 (it) 2016-07-19 2018-01-19 Jointherapeutics S R L Composizioni comprendenti una matrice polisaccaridica per il rilascio controllato di principi attivi.
US11110073B2 (en) 2017-03-24 2021-09-07 Cadila Healthcare Limited Storage stable aqueous injectable solution comprising diclofenac
EP3388054A1 (de) 2017-04-12 2018-10-17 Athenion AG Spenderkappe mit einem solubilisat eines pharmazeutisch wirksamen mittels oder nahrungszusatzes
US20220280463A1 (en) 2019-09-09 2022-09-08 Ftf Pharma Private Limited Pharmaceutical formulations comprising diclofenac
US11707443B2 (en) 2019-09-26 2023-07-25 Rk Pharma Inc. Storage stable aqueous parenteral solutions comprising diclofenac

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ZA949182B (en) * 1993-12-02 1995-07-26 South African Druggists Ltd Pharmaceutical composition
US5554650A (en) * 1994-07-28 1996-09-10 Southern Research Institute Antiphlogistic, analgesic, antipyretic injection preparation
HU228855B1 (en) * 1997-03-12 2013-06-28 Abbott Lab Hydrophilic binary systems for the administration of cyclosporine
US6365180B1 (en) 1998-01-20 2002-04-02 Glenn A. Meyer Oral liquid compositions
US6495164B1 (en) * 2000-05-25 2002-12-17 Alkermes Controlled Therapeutics, Inc. I Preparation of injectable suspensions having improved injectability
US20020016359A1 (en) * 2000-06-29 2002-02-07 Hellberg Mark R. Compositions and methods of treating neurodegenerative diseases
WO2003002153A1 (en) * 2001-06-28 2003-01-09 Wyeth Composition and method for reducing adverse interactions between phenothiazine derivatives and plasma using cyclodextrins

Also Published As

Publication number Publication date
JP2006008684A (ja) 2006-01-12
US7423028B2 (en) 2008-09-09
KR101202649B1 (ko) 2012-11-19
EP1609481A1 (de) 2005-12-28
US20050282776A1 (en) 2005-12-22
DE602005002495D1 (de) 2007-10-31
CA2510813C (en) 2013-02-12
CA2510813A1 (en) 2005-12-22
KR20060049413A (ko) 2006-05-18
ITMI20041245A1 (it) 2004-09-22
ES2293482T3 (es) 2008-03-16
CN100569230C (zh) 2009-12-16
EP1609481B1 (de) 2007-09-19
CN1711996A (zh) 2005-12-28
DK1609481T3 (da) 2008-01-07
DE602005002495T2 (de) 2008-06-12
JP5113323B2 (ja) 2013-01-09
PT1609481E (pt) 2007-12-31
PL1609481T3 (pl) 2008-02-29

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