DK2231193T3 - Lægemiddelleveringssystem til administration af et vandopløseligt, kationisk og amfifilt farmaceutisk aktivt stof - Google Patents

Lægemiddelleveringssystem til administration af et vandopløseligt, kationisk og amfifilt farmaceutisk aktivt stof Download PDF

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Publication number
DK2231193T3
DK2231193T3 DK08863195.7T DK08863195T DK2231193T3 DK 2231193 T3 DK2231193 T3 DK 2231193T3 DK 08863195 T DK08863195 T DK 08863195T DK 2231193 T3 DK2231193 T3 DK 2231193T3
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methyl ester
delivery system
sodium salt
pharmaceutically active
drug delivery
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DK08863195.7T
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English (en)
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Julian Aleksov
Igor Lokot
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Ardenia Investments Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/5123Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
    • A61K31/232Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms having three or more double bonds, e.g. etretinate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/54Medicinal 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 compound
    • A61K47/541Organic ions forming an ion pair complex with the pharmacologically or therapeutically active agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (11)

1. Lægemiddelleveringssystem til administration af mindst ét farmaceutisk aktivt stof, der er en kationisk amfifil i sig selv og mindst ét andet farmaceutisk aktivt stof med en opløselighed per se i vand på mindre end 100 pg/ml, hvilke farmaceutisk aktive stoffer er til stede i lægemiddelleveringssystemet i partikler af et kompleks mellem nævnte farmaceutisk aktive stoffer og et natriumsalt af methylesteren af N-alle-trans-retinoylcysteinsyre, et natriumsalt af methylester af N-13-cis-retinoylcysteinsyre, eller en kombination deraf, hvor nævnte partikler af nævnte kompleks har en effektiv gennemsnitlig partikelstørrelse på mindre end 100 nm, hvor - partiklerne af nævnte kompleks er i alt væsentligt amorfe; - partiklerne af nævnte kompleks er indespærret i nanopartikler dannet af et natriumsalt af methylesteren af N-alle-trans-retinoylcysteinsyre, natriumsalt af methylester af N-13-cis-retinoylcysteinsyre, eller en kombination deraf; og - vægt-til-vægt-forholdet af nævnte natriumsalt af methylester af N-alle-trans-retinoylcysteinsyre, natriumsalt af methylester af N-13-cis-retinoylcysteinsyre, eller kombination deraf, til vægten af nævnte kompleks er i området fra 0,5:1 til 20:1.
2. Lægemiddelleveringssystem ifølge krav 1, kendetegnet ved, at nævnte farmaceutisk aktive stof har en opløselighed per se i vand på mindst 4 mg/ml, og at nævnte kompleks er et ikke-kovalent kompleks med en opløselighed i vand på under 0,1 mg/ml.
3. Lægemiddelleveringssystem ifølge krav 1 eller 2, kendetegnet ved, at nævnte kompleks har en effektiv gennemsnitlig partikelstørrelse på mindre end omkring 50 nm.
4. Lægemiddelleveringssystem ifølge et hvilket som helst af de foregående kravene, kendetegnet ved, at vægt-til-vægt-forholdet af nævnte natriumsalt af methylesteren af N-alle-trans-retinoylcysteinsyre, natriumsalt af methylesteren af N-13-cis-retinoylcysteinsyre, eller kombination deraf, til vægten af nævnte kompleks er i området fra 1:1 til 10:1.
5. Lægemiddelleveringssystem ifølge et hvilket som helst af de foregående krav, kendetegnet ved, at mindst ét af nævnte farmaceutisk aktive stoffer er en cytotoksisk eller en cytostatisk forbindelse i hvilken nævnte cytotoksiske eller en cytostatisk forbindelse er en protoneret form af doxorubicin, mitoxantron, epirubicin, daunorubicin, idarubicin, topotecan, irinotecan, vinblastin, vineristin, vinorelbin, amsacrin, procarbazin, mechlorethamin, eller en kombination deraf.
6. Lægemiddelleveringssystem ifølge et hvilket som helst af de foregående krav, kendetegnet ved, at nævnte andet farmaceutisk aktive stof er en cytotoksisk eller cytostatisk forbindelse.
7. Lægemiddelleveringssystem ifølge krav 6, kendetegnet ved, at nævnte cytotoksiske eller cytostatiske forbindelse er en taxan, i hvilken nævnte taxan er valgt blandt paclitaxel, docetaxel, og derivater deraf.
8. Lægemiddelleveringssystem ifølge krav 1, kendetegnet ved, at nævnte mindst ene farmaceutisk aktive stof og nævnte andet farmaceutisk aktive stof er cytotoksiske eller cytostatiske forbindelser, i hvilke nævnte mindst ene farmaceutisk aktive stof er en protoneret form af doxorubicin, mitoxantron, epirubicin, daunorubicin, idarubicin, topotecan, irinotecan, vinblastin, vineristin, vinorelbin, amsacrin, procarbazin, mechlorethamin, eller en kombination deraf.
9. Lægemiddelleveringssystem ifølge krav 1, kendetegnet ved, at nævnte andet farmaceutisk aktive stof er en taxan, hvor nævnte taxan er valgt blandt paclitaxel, docetaxel, og derivater deraf.
10. Lægemiddelleveringssystem ifølge et hvilket som helst af kravene 1-9 til anvendelse i behandlingen af cancer.
11. Farmaceutisk sammensætning omfattende en farmaceutisk acceptabel bærer og lægemiddelleveringssystemet ifølge et hvilket som helst af kravene 1-10.
DK08863195.7T 2007-12-19 2008-12-18 Lægemiddelleveringssystem til administration af et vandopløseligt, kationisk og amfifilt farmaceutisk aktivt stof DK2231193T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/SE2007/001128 WO2009078755A1 (en) 2007-12-19 2007-12-19 Drug delivery system for administration of a water soluble, cationic and amphiphilic pharmaceutically active substance
PCT/SE2008/051517 WO2009078804A1 (en) 2007-12-19 2008-12-18 Drug delivery system for administration of a water soluble, cationic and amphiphilic pharmaceutically active substance

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US (1) US8324274B2 (da)
EP (1) EP2231193B1 (da)
JP (1) JP5466174B2 (da)
KR (1) KR101616135B1 (da)
CN (1) CN101945671B (da)
AU (1) AU2008339101B2 (da)
BR (1) BRPI0821739B8 (da)
CA (1) CA2709268C (da)
CY (1) CY1121145T1 (da)
DK (1) DK2231193T3 (da)
EA (1) EA018559B1 (da)
ES (1) ES2689509T3 (da)
HR (1) HRP20181517T1 (da)
HU (1) HUE039695T2 (da)
LT (1) LT2231193T (da)
MX (1) MX2010006906A (da)
MY (1) MY150820A (da)
NZ (1) NZ586858A (da)
PL (1) PL2231193T3 (da)
PT (1) PT2231193T (da)
SI (1) SI2231193T1 (da)
WO (2) WO2009078755A1 (da)
ZA (1) ZA201004992B (da)

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Publication number Priority date Publication date Assignee Title
WO2009078756A1 (en) 2007-12-19 2009-06-25 Ardenia Investments, Ltd. Drug delivery system for administration of a water soluble, cationic and amphiphilic pharmaceutically active substance
WO2009078754A1 (en) * 2007-12-19 2009-06-25 Ardenia Investments, Ltd. Drug delivery system for administration of poorly water soluble pharmaceutically active substances
CN112321465B (zh) * 2019-07-18 2023-06-06 上海现代药物制剂工程研究中心有限公司 一种含苯基化合物、其中间体、制备方法及应用
CN112239418B (zh) * 2019-07-18 2023-07-07 上海现代药物制剂工程研究中心有限公司 视黄醇类化合物及其钠盐的制备方法

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WO2009078756A1 (en) 2007-12-19 2009-06-25 Ardenia Investments, Ltd. Drug delivery system for administration of a water soluble, cationic and amphiphilic pharmaceutically active substance
WO2009078754A1 (en) 2007-12-19 2009-06-25 Ardenia Investments, Ltd. Drug delivery system for administration of poorly water soluble pharmaceutically active substances

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Publication number Publication date
BRPI0821739B8 (pt) 2021-05-25
JP2011507840A (ja) 2011-03-10
EP2231193B1 (en) 2018-07-18
MX2010006906A (es) 2010-11-10
KR101616135B1 (ko) 2016-04-27
EP2231193A4 (en) 2014-12-03
AU2008339101A1 (en) 2009-06-25
ES2689509T3 (es) 2018-11-14
CN101945671B (zh) 2012-08-22
HUE039695T2 (hu) 2019-01-28
EA018559B1 (ru) 2013-08-30
KR20100099290A (ko) 2010-09-10
WO2009078755A1 (en) 2009-06-25
SI2231193T1 (sl) 2018-12-31
CY1121145T1 (el) 2020-05-29
AU2008339101B2 (en) 2015-08-06
BRPI0821739A2 (pt) 2015-06-16
PL2231193T3 (pl) 2019-01-31
CA2709268A1 (en) 2009-06-25
WO2009078804A1 (en) 2009-06-25
CN101945671A (zh) 2011-01-12
PT2231193T (pt) 2018-11-02
MY150820A (en) 2014-02-28
US20110236472A1 (en) 2011-09-29
EA201070626A1 (ru) 2010-12-30
ZA201004992B (en) 2011-03-30
BRPI0821739B1 (pt) 2021-03-02
NZ586858A (en) 2012-06-29
LT2231193T (lt) 2018-11-12
JP5466174B2 (ja) 2014-04-09
HRP20181517T1 (hr) 2018-11-30
CA2709268C (en) 2016-02-09
US8324274B2 (en) 2012-12-04
EP2231193A1 (en) 2010-09-29

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