DK2477608T3 - Fast oral doseringsform med nanopartikler samt fremgangsmåde til formulering af denne under anvendelse af fiskegelatine - Google Patents

Fast oral doseringsform med nanopartikler samt fremgangsmåde til formulering af denne under anvendelse af fiskegelatine Download PDF

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Publication number
DK2477608T3
DK2477608T3 DK10817696.7T DK10817696T DK2477608T3 DK 2477608 T3 DK2477608 T3 DK 2477608T3 DK 10817696 T DK10817696 T DK 10817696T DK 2477608 T3 DK2477608 T3 DK 2477608T3
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DK
Denmark
Prior art keywords
dosage form
solid dosage
oral solid
freeze
fish gelatin
Prior art date
Application number
DK10817696.7T
Other languages
English (en)
Inventor
Deepak Bahl
Kieran James Crowley
Danny Yu
Original Assignee
Rp Scherer Technologies Llc
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.)
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Publication of DK2477608T3 publication Critical patent/DK2477608T3/da

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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
    • A61K9/48—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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5169—Proteins, e.g. albumin, gelatin
    • 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
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Optics & Photonics (AREA)
  • Nanotechnology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (15)

1. Fremgangsmåde til fremstilling af en oral fast doseringsform indeholdende nanopartikler, hvilken fremgangsmåde omfatter følgende trin: (a) nedbringelse af partikelstørrelsen af mindst ét i en opløsning indeholdende fiskegelatine dispergeret farmaceutisk aktivt stof til dannelse af en nanosuspension; og (b) frysetørring af nanosuspensionen fra trin (a) til dannelse af den orale faste doseringsform.
2. Fremgangsmåde ifølge krav 1, ved hvilken fiskegelatinen er en ikke-gelerende, ikke-hydroseret fiskegelatine eller en kombination af flere ikke-gelerende, ikke-hydrolyserede fiskegelatiner.
3. Fremgangsmåde ifølge krav 1, ved hvilken nanosuspensionen endvidere omfatter mindst ét farmaceutisk excipiens.
4. Fremgangsmåde ifølge krav 3, ved hvilken det eller de farmaceutiske excipienser er valgt blandt fyldemidler, kemiske stabilisatorer, sprængemidler, viskositetsmodificerende midler, sødemidler, smagsstoffer, farvemidler, pH-modificerende midler og kombinationer deraf.
5. Fremgangsmåde ifølge krav 1, ved hvilken det eller de farmaceutisk aktive stoffer har en målt opløselighed mindre end 1 mg/ml.
6. Oral fast doseringsform indeholdende nanopartikler fremstillet ved en fremgangsmåde omfattende følgende trin: (a) nedbringelse af partikelstørrelsen af mindst ét i en opløsning indeholdende fiskegelatine dispergeret farmaceutisk aktivt stof til dannelse af en nanosuspension; og (b) frysetørring af nanosuspensionen fra trin (a) til dannelse af den orale faste doseringsform.
7. Oral fast doseringsform ifølge krav 6, hvori fiskegelatinen er en ikke-gelerende, ikke-hydroseret fiskegelatine eller en kombination af flere ikke-gelerende, ikke-hydrolyserede fiskegelatiner.
8. Oral fast doseringsform ifølge krav 6, hvori nanosuspensionen endvidere omfatter mindst ét farmaceutisk excipiens.
9. Oral fast doseringsform ifølge krav 8, hvori det eller de farmaceutiske excipienser er valgt blandt fyldemidler, kemiske stabilisatorer, sprængemidler, viskositetsmodificerende midler, sødemidler, smagsstoffer, farvemidler, pH-modificerende midler og kombinationer deraf.
10. Oral fast doseringsform ifølge krav 6, hvori det eller de farmaceutisk aktive stoffer har en målt opløselighed mindre end 1 mg/ml.
11. Frysetørret oral fast doseringsform omfattende mindst ét farmaceutisk aktivt stof i nanopartikelform og fiskegelatine.
12. Frysetørret oral fast doseringsform ifølge krav 11, hvori fiskegelatinen er en ikke-gelerende, ikke-hydroseret fiskegelatine eller en kombination af flere ikke-gelerende, ikke-hydrolyserede fiskegelatiner.
13. Frysetørret oral fast doseringsform ifølge krav 11, som endvidere omfatter mindst ét farmaceutisk excipiens.
14. Frysetørret oral fast doseringsform ifølge krav 13, hvori det eller de farmaceutiske excipienser er valgt blandt fyldemidler, kemiske stabilisatorer, sprængemidler, viskositetsmodificerende midler, sødemidler, smagsstoffer, farvemidler, pH-modificerende midler og kombinationer deraf.
15. Frysetørret oral fast doseringsform ifølge krav 11, hvori det eller de farmaceutisk aktive stoffer har en målt opløselighed mindre end 1 mg/ml.
DK10817696.7T 2009-09-16 2010-09-13 Fast oral doseringsform med nanopartikler samt fremgangsmåde til formulering af denne under anvendelse af fiskegelatine DK2477608T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/560,813 US9775819B2 (en) 2009-09-16 2009-09-16 Oral solid dosage form containing nanoparticles and process of formulating the same using fish gelatin
PCT/US2010/048588 WO2011034809A1 (en) 2009-09-16 2010-09-13 Oral solid dosage form containing nanoparticles and process of formulating the same using fish gelatin

Publications (1)

Publication Number Publication Date
DK2477608T3 true DK2477608T3 (da) 2015-01-19

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DK10817696.7T DK2477608T3 (da) 2009-09-16 2010-09-13 Fast oral doseringsform med nanopartikler samt fremgangsmåde til formulering af denne under anvendelse af fiskegelatine

Country Status (15)

Country Link
US (1) US9775819B2 (da)
EP (1) EP2477608B1 (da)
JP (1) JP5707405B2 (da)
KR (1) KR101714688B1 (da)
CN (1) CN102686218B (da)
AR (1) AR080662A1 (da)
AU (1) AU2010295781B2 (da)
BR (1) BR112012005969A2 (da)
CA (1) CA2774210C (da)
DK (1) DK2477608T3 (da)
ES (1) ES2527225T3 (da)
HK (1) HK1175984A1 (da)
IL (1) IL218598A (da)
MX (2) MX2012003204A (da)
WO (1) WO2011034809A1 (da)

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Also Published As

Publication number Publication date
EP2477608A1 (en) 2012-07-25
AU2010295781B2 (en) 2015-07-09
HK1175984A1 (en) 2013-07-19
WO2011034809A1 (en) 2011-03-24
MX349106B (es) 2017-07-12
ES2527225T3 (es) 2015-01-21
KR20120089815A (ko) 2012-08-13
AR080662A1 (es) 2012-05-02
US20110064812A1 (en) 2011-03-17
EP2477608B1 (en) 2014-10-29
US9775819B2 (en) 2017-10-03
CN102686218A (zh) 2012-09-19
CA2774210C (en) 2017-08-29
IL218598A0 (en) 2012-05-31
BR112012005969A2 (pt) 2017-06-06
CN102686218B (zh) 2017-12-19
MX2012003204A (es) 2012-05-29
AU2010295781A1 (en) 2012-04-19
CA2774210A1 (en) 2011-03-24
KR101714688B1 (ko) 2017-03-09
EP2477608A4 (en) 2013-03-06
JP5707405B2 (ja) 2015-04-30
IL218598A (en) 2015-09-24
JP2013505243A (ja) 2013-02-14

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