DK3076947T3 - Kontrastmiddel indeholdende smagsmaskerende formuleringer - Google Patents

Kontrastmiddel indeholdende smagsmaskerende formuleringer Download PDF

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Publication number
DK3076947T3
DK3076947T3 DK14837037.2T DK14837037T DK3076947T3 DK 3076947 T3 DK3076947 T3 DK 3076947T3 DK 14837037 T DK14837037 T DK 14837037T DK 3076947 T3 DK3076947 T3 DK 3076947T3
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Denmark
Prior art keywords
gas
liquid
imaging
agent
oral formulation
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DK14837037.2T
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English (en)
Inventor
Courtney Rouse Smith
Conrad Winters
Marcio TEMTEM
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Hovione Scientia Ltd
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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate 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
    • A61K9/146—Intimate 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 macromolecular compounds
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/04—X-ray contrast preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/04—X-ray contrast preparations
    • A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
    • A61K49/0447—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound
    • A61K49/0476—Particles, beads, capsules, spheres
    • A61K49/048—Microparticles, microbeads, microcapsules, microspheres, i.e. having a size or diameter higher or equal to 1 micrometer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/04—X-ray contrast preparations
    • A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
    • A61K49/0447—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound
    • A61K49/0495—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound intended for oral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/18—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by a special physical form, e.g. emulsions, microcapsules, liposomes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/1241—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules particles, powders, lyophilizates, adsorbates, e.g. polymers or resins for adsorption or ion-exchange resins
    • A61K51/1244—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules particles, powders, lyophilizates, adsorbates, e.g. polymers or resins for adsorption or ion-exchange resins microparticles or nanoparticles, e.g. polymeric nanoparticles
    • 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
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (15)

1. Oral formulering omfattende et ioderet afbildningsmiddel og i det mindste ét smagsmaskeringsmiddel, hvor det ioderede afbildningsmiddel er indkapslet i det smagsmaskerende middel som partikler, hvor det ioderede afbildningsmiddel er en vandopløselig organisk eller polymer forbindelse, som indeholder én eller flere iodsubstituenter og hvor det smagsmaskerende middel er valgt blandt én eller flere polymerer, overfladeaktive midler og sukker.
2. Oral formulering ifølge krav 1, hvor afbildningsmidlet er iopamidol, iohexol eller iodixanol.
3. Oral formulering ifølge krav 1 eller 2, hvor afbildningsmidlet udgør op til 90 vaegt-%.
4. Oral formulering ifølge krav 1, som yderligere omfatter et vilkårligt enkelt eller flere af følgende træk: (i) hvor ét eller flere smagsmaskerende midler vælges blandt hydroxypropylmethyl-celluloseacetatsuccinat, poly(methacrylsyre-co-methyl-methacrylat), og glyceryl-palmitostearat; (ii) hvor det smagsmaskerende middel er hydroxypropylmethylcelluloseacetat-succinat; (iii) hvor det smagsmaskerende middel er poly(methacrylsyre-co-methyl-meth-acrylat).
5. Oral formulering ifølge ethvert af kravene 1 til 4, som yderligere omfatter ét eller flere excipienser, hvor excipienset er valgt fra gruppen bestående af polymerer, overfladeaktive stoffer, lipider eller vokser, fedtsyrer, sukkere og smagsstoffer.
6. Oral formulering ifølge ethvert af kravene 1 til 5, hvor partiklerne har i det mindste ét af følgende træk: (i) en partikelstørrelse i området mellem 1 og 500 pm diameter; (ii) et overfladeareal imellem 0,5 og 100 m2/g som målt under anvendelse af Brunauer-Emmett-Teller (BET) overfladearealmetoden; (iii) en partikel til partikelkohæsion og en spids bioadhæsionsstyrke på op til 500 kPa som målt under anvendelse af et pulverrheometer.
7. Oral formulering ifølge ethvert af kravene 1 til 6, hvor formuleringen er iso-osmotisk eller hypo-osmotisk.
8. Fremgangsmåde til fremstilling af en formulering ifølge ethvert af kravene 1 til 7, hvilken fremgangsmåde omfatter: (a) indføring af en smeltet blanding omfattende ét eller flere ioderede afbildningsmidler og ét eller flere smagsmaskerende midler til en dyse; (b) forstøvning af den smeltede blanding til dråber; og (c) afkøling af dråberne til partikler.
9. Fremgangsmåde ifølge krav 8, som yderligere omfatter smeltning af ét eller flere ioderede afbildningsmidler eventuelt omfattende ét eller flere excipienser før trin a), for tilvejebringelse af den smeltede blanding; hvor eventuelt smeltningen foretages ved en temperatur på imellem 20 og 250°C.
10. Fremgangsmåde ifølge krav 8 eller 9, hvor afkølingen fremmes ved en strøm af gas eller væske, eventuelt hvor strømmen af gas eller væske er enhver af følgende: (i) den nævnte strøm af gas eller væske foreligger ved en starttemperatur på imellem -40 og 100°C; (ii) den nævnte strøm af gas eller væske er i medstrøm eller modstrøm med retningen af den sprøjtede smelte; (iii) strømmen af gas eller væske er en strøm af gas omfattende nitrogen, luft, kuldioxid eller blandinger deraf; (iv) strømmen af gas eller væske er en strøm af gas kombineret med en strøm af væske omfattende flydende kuldioxid eller flydende nitrogen.
11. Fremgangsmåde til fremstilling af en formulering ifølge ethvert af kravene 1 til 7, hvilken fremgangsmåde omfatter: (a) blanding af ét eller flere ioderede midler og ét eller flere smagsmaskerende midler i et opløsningsmiddel eller blanding af opløsningsmidler for tilvejebringelse af en opløsning eller en suspension; (b) tilførsel og forstøvning af opløsningen eller suspensionen ind i et tørrekammer for at opnå dråber; eventuelt er tilførslen til en dyse og (c) tørring af dråberne til partikler.
12. Fremgangsmåde ifølge krav 11, hvor tørringen fremmes af en strøm af gas eller væske, eventuelt foretages tørringen ved en temperatur på imellem 20 og 300°C.
13. Fremgangsmåde ifølge ethvert af kravene 8, 9, 11 eller 12, hvor dysen kan have en rotations-, tryk-, fluid- eller ultralydskonfiguration.
14. Fremgangsmåde ifølge krav 12, som yderligere omfatter ét eller flere af følgende træk: (i) hvor strømmen af gas eller væske er medstrøms i forhold til retningen af den sprøjtede smelte; (ii) hvor strømmen af gas omfatter nitrogen, luft, kuldioxid eller blandinger deraf; (iii) hvor strømmen af gas er varm nitrogen.
15. Fremgangsmåde til afbildning af mave-tarm-kanalen i en patient, omfattende indgivelse til patienten af en oral formulering i overensstemmelse med ethvert af kravene 1 til 7, eventuelt er mave-tarm-kanalen den øvre mave-tarm-kanal.
DK14837037.2T 2013-12-04 2014-12-04 Kontrastmiddel indeholdende smagsmaskerende formuleringer DK3076947T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361911950P 2013-12-04 2013-12-04
PCT/IB2014/003029 WO2015082998A1 (en) 2013-12-04 2014-12-04 Contrast media taste masking formulations

Publications (1)

Publication Number Publication Date
DK3076947T3 true DK3076947T3 (da) 2018-09-17

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DK14837037.2T DK3076947T3 (da) 2013-12-04 2014-12-04 Kontrastmiddel indeholdende smagsmaskerende formuleringer

Country Status (19)

Country Link
US (1) US20150151008A1 (da)
EP (1) EP3076947B1 (da)
JP (1) JP6507166B2 (da)
KR (1) KR20160119060A (da)
CN (1) CN105899189A (da)
AU (1) AU2014358858B2 (da)
BR (1) BR112016012912A8 (da)
CA (1) CA2932380A1 (da)
DK (1) DK3076947T3 (da)
ES (1) ES2683154T3 (da)
HU (1) HUE039982T2 (da)
IL (1) IL246012A0 (da)
MX (1) MX2016007347A (da)
PL (1) PL3076947T3 (da)
PT (1) PT3076947T (da)
RU (1) RU2683568C1 (da)
SG (1) SG11201604507RA (da)
TR (1) TR201809617T4 (da)
WO (1) WO2015082998A1 (da)

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Publication number Priority date Publication date Assignee Title
JP7035449B2 (ja) * 2017-10-26 2022-03-15 富士フイルムビジネスイノベーション株式会社 装置、管理システム及びプログラム
ES2967689T3 (es) * 2018-04-06 2024-05-03 Capsugel Belgium Nv Proceso de secado por aspersión para partículas de baja relación de aspecto que comprenden poli[(metacrilato de metilo)-co-(ácido metacrílico)]
KR102158794B1 (ko) 2019-12-31 2020-09-22 서울대학교산학협력단 방사선 검사 및 초음파 검사에 사용하기 위한 다목적 조영제

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DE2505218A1 (de) * 1975-02-05 1976-08-19 Schering Ag Neue orale roentgenkontrastmittel und verfahren zu ihrer herstellung
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GB9020091D0 (en) * 1990-09-14 1990-10-24 Nycomed As Contrast media
CA2094893A1 (en) * 1992-05-01 1993-11-02 Carl R. Illig X-ray contrast compositions containing film-forming materials
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KR20000071207A (ko) * 1997-03-04 2000-11-25 요시히로 미와 엑스선 조영제
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FR2848855B1 (fr) * 2002-12-23 2005-02-11 Aventis Pharma Sa Compositions pour administration orale de principes actifs necessitant un masquage du gout
US20050180920A1 (en) * 2003-01-29 2005-08-18 Vincenzo Giuliano Oral contrast media composition for computerized axial tomographic examinations and method
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JP2009143879A (ja) * 2007-12-18 2009-07-02 Konica Minolta Holdings Inc リポソーム及びｘ線用造影剤

Also Published As

Publication number Publication date
HUE039982T2 (hu) 2019-02-28
EP3076947A1 (en) 2016-10-12
WO2015082998A1 (en) 2015-06-11
IL246012A0 (en) 2016-07-31
CN105899189A (zh) 2016-08-24
PT3076947T (pt) 2018-10-17
JP2016539159A (ja) 2016-12-15
RU2683568C1 (ru) 2019-03-29
EP3076947B1 (en) 2018-06-13
PL3076947T3 (pl) 2019-02-28
JP6507166B2 (ja) 2019-04-24
TR201809617T4 (tr) 2018-07-23
BR112016012912A8 (pt) 2018-01-30
KR20160119060A (ko) 2016-10-12
US20150151008A1 (en) 2015-06-04
MX2016007347A (es) 2016-10-26
SG11201604507RA (en) 2016-07-28
AU2014358858A1 (en) 2016-06-23
CA2932380A1 (en) 2015-06-11
ES2683154T3 (es) 2018-09-25
AU2014358858B2 (en) 2018-09-13
BR112016012912A2 (pt) 2017-08-08

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