DK2512455T3 - Sambehandlet tablethjælpestofsammensætning, dens fremstilling og anvendelse - Google Patents

Sambehandlet tablethjælpestofsammensætning, dens fremstilling og anvendelse Download PDF

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Publication number
DK2512455T3
DK2512455T3 DK10803658.3T DK10803658T DK2512455T3 DK 2512455 T3 DK2512455 T3 DK 2512455T3 DK 10803658 T DK10803658 T DK 10803658T DK 2512455 T3 DK2512455 T3 DK 2512455T3
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DK
Denmark
Prior art keywords
lactose
lubricant
excipient
composition
treated
Prior art date
Application number
DK10803658.3T
Other languages
English (en)
Inventor
Gessel Alexander Wilhelmus Van
Original Assignee
Frieslandcampina Nederland Holding B V
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 date
Application filed by Frieslandcampina Nederland Holding B V filed Critical Frieslandcampina Nederland Holding B V
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Publication of DK2512455T3 publication Critical patent/DK2512455T3/da

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Classifications

    • 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
    • A61K9/2095—Tabletting processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)

Claims (8)

1. Sambehandlet hjælpestofsammensætning egnet til tabletfremstilling, hvilken sammensætning omfatter granulatpartikler, hvilket granulatpartikler omfatter mindst et fyldstof-bindemiddel, mindst et nedbrydningsmiddel og mindst et smøremiddel, som er blevet underkastet granulering sammen, og hvilke granulatpartikler er i det mindst delvist overtrukket med laktose.
2. Sambehandlet hjælpestofsammensætning ifølge krav 1, som kan tilvejebringes ved fluid-bed granulering, hvori en laktoseopløsning er sprøjtet på det mindst ene fyldstof-bindemiddel, mindst et nedbrydningsmiddel og mindst et smøremiddel under granulering.
3. Sam behandlet hjælpestofsammensætning ifølge krav 1 eller 2, omfattende laktose, mikrokrystallinsk cellulose (MCC) og krydsbundet natriumstivelseglykolat (SSG).
4. Sam behandlet hjælpestofsammensætning ifølge ethvert af de foregående krav, omfattende grove eller uregelmæssigt formet granulatpartikler med en gennemsnitlig partikelstørrelse mindre end 0,500 mm.
5. Sam behandlet hjælpestofsammensætning ifølge ethvert af de foregående krav, omfattende 40 - 70 % laktose, 20 - 50 % MCC, 1 - 10 % krydsbundet natriumstivelseglykolat og 0,2 - 1% smøremiddel baseret på sammensætningens samlede tørvægt.
6. Pose eller tromle omfattende den sambehandlede hjælpestofsammensætning ifølge ethvert af de foregående krav.
7. Fremgangsmåde til fremstilling af en sambehandlet hjælpestofsammensætning, omfattende tilvejebringelse af en blanding indeholdende mindst et fyldstof-bindemiddel, mindst et nedbrydningsmiddel og mindst et smøremiddel, og granulering af blandingen i en fluid-bed granulator, hvori en opløsning omfattende laktose sprøjtes på fluid-bed’en indeholdende det mindst ene fyldstof-bindemiddel og mindst et nedbrydningsmiddel.
8. Tabletfremstillingsproces, som indebærer blanding af den sambehandlede hjælpestofsammensætning ifølge ethvert af krav 1 - 5 med en aktiv farmaceutisk ingrediens til dannelse af en aktiv farmaceutisk ingrediensblanding, samt fremstilling af tabletter af den aktive farmaceutiske ingrediensblanding.
DK10803658.3T 2009-12-18 2010-12-16 Sambehandlet tablethjælpestofsammensætning, dens fremstilling og anvendelse DK2512455T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09179867 2009-12-18
PCT/NL2010/050855 WO2011074961A1 (en) 2009-12-18 2010-12-16 Co-processed tablet excipient composition its preparation and use

Publications (1)

Publication Number Publication Date
DK2512455T3 true DK2512455T3 (da) 2014-03-24

Family

ID=42173967

Family Applications (1)

Application Number Title Priority Date Filing Date
DK10803658.3T DK2512455T3 (da) 2009-12-18 2010-12-16 Sambehandlet tablethjælpestofsammensætning, dens fremstilling og anvendelse

Country Status (6)

Country Link
US (1) US10071059B2 (da)
EP (1) EP2512455B8 (da)
JP (1) JP5714600B2 (da)
DK (1) DK2512455T3 (da)
ES (1) ES2453477T3 (da)
WO (1) WO2011074961A1 (da)

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EP3002005A1 (en) 2014-09-30 2016-04-06 Molkerei Meggle Wasserburg GmbH & Co. Kg Direct compression excipient based on lactose, cellulose and starch
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Also Published As

Publication number Publication date
EP2512455A1 (en) 2012-10-24
EP2512455B8 (en) 2014-07-23
US20130177649A1 (en) 2013-07-11
ES2453477T3 (es) 2014-04-07
US10071059B2 (en) 2018-09-11
WO2011074961A1 (en) 2011-06-23
EP2512455B1 (en) 2014-01-15
JP2013514349A (ja) 2013-04-25
JP5714600B2 (ja) 2015-05-07

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