DK2484350T3 - Farmaceutisk præparat, indeholdende et kompleks af et propofolsalt med en cyclodextrin - Google Patents

Farmaceutisk præparat, indeholdende et kompleks af et propofolsalt med en cyclodextrin Download PDF

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Publication number
DK2484350T3
DK2484350T3 DK11153452.5T DK11153452T DK2484350T3 DK 2484350 T3 DK2484350 T3 DK 2484350T3 DK 11153452 T DK11153452 T DK 11153452T DK 2484350 T3 DK2484350 T3 DK 2484350T3
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DK
Denmark
Prior art keywords
propofol
formulation according
salt
cyclodextrin
complex
Prior art date
Application number
DK11153452.5T
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English (en)
Inventor
Norbert Univ -Prof Dr Med Roewer
Jens Dr Med Broscheit
Original Assignee
Norbert Univ -Prof Dr Med Roewer
Jens Dr Med Broscheit
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 Norbert Univ -Prof Dr Med Roewer, Jens Dr Med Broscheit filed Critical Norbert Univ -Prof Dr Med Roewer
Application granted granted Critical
Publication of DK2484350T3 publication Critical patent/DK2484350T3/da

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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
    • A61K47/51—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 non-active ingredient being a modifying agent
    • A61K47/56—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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61—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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K9/0012—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
    • 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
    • A61P23/00—Anaesthetics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Anesthesiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1
1. Farmaceutisk formulering, som indeholder et kompleks af et propofolsalt med 2-hydroxypropyl-p-cyclodextrin (HPBCD).
2. Formulering ifølge krav 1, kendetegnet ved, at propofolsaltet er et alkalimetalsalt.
3. Formulering ifølge krav 2, kendetegnet ved, at propofolsaltet er et natriumsalt.
4. Formulering ifølge et af kravene 1 til 3, kendetegnet ved, at molforholdet propofolsalt:cyclodextrin er 1:2 til 1:6, fortrinsvis 1:2 til 1:4, mere foretrukket ca. 1:2.
5. Formulering ifølge et af kravene 1 til 3, kendetegnet ved, at propofolsalt-indholdet i komplekset udgør 4 til 9 vægt-%.
6. Formulering ifølge et af kravene 1 til 5, kendetegnet ved, at den er en vandig opløsning, der er egnet til injektion.
7. Formulering ifølge krav 6, kendetegnet ved, at pFI-værdien ligger mellem 7 og 11, fortrinsvis mellem 8 og 11, mere fortrinsvis mellem 9 og 11, og endnu mere fortrinsvis mellem 9 og 10.
8. Formulering ifølge et af kravene 1 til 5, kendetegnet ved, at den er et vandopløseligt faststof.
9. Formulering ifølge et af kravene 1 til 8 til anvendelse som anæstetikum.
10. Fremgangsmåde til fremstilling af en formulering ifølge et af kravene 1 til 7, kendetegnet ved de følgende trin: a) at fremstille en alkalisk vandig opløsning af cyclodextrinen, b) at opløse propofol i den alkaliske vandige opløsning. 2
11. Fremgangsmåde ifølge krav 10, kendetegnet ved, at opløsningen af propofolet foregår under inertgasatmosfære.
12. Fremgangsmåde ifølge krav 10 eller 11, kendetegnet ved, at opløsnin-5 gen af propofolet foregår over et tidsrum på 2 til 10 h, fremgangsmåde 3 til 5 h, mere fortrinsvis ca. 4 h.
13. Fremgangsmåde ifølge et af kravene 10 til 12, kendetegnet ved, at den i trin b) tilvejebragte opløsning filtreres. 0
14. Fremgangsmåde ifølge et af kravene 10 til 13, kendetegnet ved, at der fjernes vand fra den i trin b) tilvejebragte og evt. filtrerede opløsning, fortrinsvis ved hjælp af frysetørring.
DK11153452.5T 2011-02-04 2011-02-04 Farmaceutisk præparat, indeholdende et kompleks af et propofolsalt med en cyclodextrin DK2484350T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP11153452.5A EP2484350B1 (de) 2011-02-04 2011-02-04 Pharmazeutische Zubereitung, enthaltend einen Komplex eines Propofolsalzes mit einem Cyclodextrin

Publications (1)

Publication Number Publication Date
DK2484350T3 true DK2484350T3 (da) 2016-08-01

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
DK11153452.5T DK2484350T3 (da) 2011-02-04 2011-02-04 Farmaceutisk præparat, indeholdende et kompleks af et propofolsalt med en cyclodextrin

Country Status (6)

Country Link
US (1) US9006215B2 (da)
EP (1) EP2484350B1 (da)
JP (1) JP5989675B2 (da)
CN (1) CN103491953A (da)
DK (1) DK2484350T3 (da)
WO (1) WO2012104730A1 (da)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102147084B1 (ko) 2012-11-15 2020-08-24 자피오텍 게엠베하 소염성 활성 물질 또는 면역 억제성 활성물질로서 델피니딘 복합제
EP2931287B1 (de) 2012-12-11 2017-10-04 Sapiotec GmbH Delphinidin zur bekämpfung von melanomzellen
LU92569B1 (en) 2014-05-28 2016-04-11 Univ Saarland Novel water soluble 6-thioalkyl-cyclodextrins and uses thereof
CN111150703A (zh) * 2018-11-07 2020-05-15 比卡生物科技（广州）有限公司 一种澄清丙泊酚注射液及其制备方法
US20220000797A1 (en) * 2018-11-07 2022-01-06 (Bika Biotechnology (Guangzhou) Co., Ltd) Clear propofol injection and preparation method therefor
FR3117337B1 (fr) * 2020-12-10 2023-04-28 Centre Hospitalier Univ De Lille Composition pharmaceutique contenant du propofol, une cyclodextrine ou un dérivé de cyclodextrine et un sel pharmaceuticalement acceptable
CN114133318B (zh) * 2021-12-09 2023-08-29 广东嘉博制药有限公司 一种降除丙泊酚产品中丙泊酚杂质o的方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ZA962214B (en) * 1995-04-10 1996-10-07 Farmarc Nederland Bv Pharmaceutical composition
IN187686B (da) * 2000-06-21 2002-06-08 Bharat Serums & Vaccines Ltd
JP4334229B2 (ja) * 2001-03-20 2009-09-30 サイデックス・ファーマシューティカルズ・インコーポレイテッド プロポフォール及びスルホアルキルエーテルシクロデキストリン含有製剤
US7034013B2 (en) * 2001-03-20 2006-04-25 Cydex, Inc. Formulations containing propofol and a sulfoalkyl ether cyclodextrin
EP1469886B8 (en) * 2002-02-01 2008-01-09 Shimoda Biotech (PTY) LTD Lyophilized pharmaceutical composition of propofol
BRPI0614628A2 (pt) * 2005-08-12 2011-04-12 Bharat Serums & Vaccines Ltd composição anestésica aquosa adequada para a administração parenteral; processo de produção de uma composição anestésica aquosa adequada para a administração parenteral; composição anestésica aquosa; e processo de produção de uma composição anestésica aquosa
EP2106786A1 (de) * 2008-04-04 2009-10-07 Roewer, Norbert, Univ.-Prof. Dr. med. Pharmazeutische Zubereitung mit permethyliertem Cyclodextrin

Also Published As

Publication number Publication date
EP2484350B1 (de) 2016-04-20
JP2014507430A (ja) 2014-03-27
CN103491953A (zh) 2014-01-01
EP2484350A1 (de) 2012-08-08
US20130316976A1 (en) 2013-11-28
WO2012104730A1 (de) 2012-08-09
US9006215B2 (en) 2015-04-14
JP5989675B2 (ja) 2016-09-07

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