DK2147669T4 - Hurtigt opløsende, robust doseringsform - Google Patents

Hurtigt opløsende, robust doseringsform Download PDF

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Publication number
DK2147669T4
DK2147669T4 DK09013477.6T DK09013477T DK2147669T4 DK 2147669 T4 DK2147669 T4 DK 2147669T4 DK 09013477 T DK09013477 T DK 09013477T DK 2147669 T4 DK2147669 T4 DK 2147669T4
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DK
Denmark
Prior art keywords
tablets
dosage form
tablet
active ingredient
present
Prior art date
Application number
DK09013477.6T
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English (en)
Other versions
DK2147669T3 (da
Inventor
Rajendra K Khankari
John Hontz
Sara J Chastain
Leo Katzner
Original Assignee
Cima Labs Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=21926209&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2147669(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cima Labs Inc filed Critical Cima Labs Inc
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Publication of DK2147669T3 publication Critical patent/DK2147669T3/da
Publication of DK2147669T4 publication Critical patent/DK2147669T4/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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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

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

Claims (10)

1. Fremgangsmåde til fremstilling af emballeret doseringsform til oral desintegration, der er tilpasset til direkte oral dosering, har en hårdhed på mindst 15 Newton og en sprødhed på 2% eller mindre, når den testes i overensstemmelse med U.S.P., hvor fremgangsmåden omfatter følgende trin: (a) danne en blanding, som indeholder en aktiv bestanddel og en matrix, som omfatter et ikke-direkte sammentrykkeligt fyldstof og et smøremiddel; (b) komprimere blandingen ved direkte sammentrykning for at danne en flerhed af hård, komprimerede, hurtigt opløsende doseringsformer, som har den aktive bestanddel fordelt i den oralt opløselige matrix, hvor doseringsformen er tilpasset til at opløses spontant i munden på en patient på under 60 sekunder og derved frigøre den aktive bestanddel; og hvor det ikke-direkte sammentrykkelige fyldstof er mannitol, der foreligger i en mængde på 25 til 95 vægt%; smøremidlet foreligger i en mængde på mellem 1 og 2,5 vægt%; og 85% af de ikke-direkte sammentrykkelige fyldstofpartikler er mindre end 100 pm; hvor det ikke-direkte sammentrykkelige fyldstof ikke ændres fysisk for at give større fluiditet og sammentrykkelighed inden sammentrykning.
2. Fremgangsmåde ifølge krav 1, endvidere omfattende: (c) lagre tabletterne i løs vægt inden emballering af tabletterne.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor sprødheden er mindre end eller lig med 1 %.
4. Fremgangsmåde ifølge krav 1 eller 2, hvor hårdheden ligger mellem 20 Newton og 50 Newton.
5. Fremgangsmåde ifølge krav 4, hvor hårdheden er 35 Newton.
6. Fremgangsmåde ifølge krav 1, hvor doseringsformen yderligere omfatter mindst én partikel, hvor partiklen indeholder den aktive bestanddel og et beskyttelsesmateriale.
7. Fremgangsmåde ifølge krav 6, hvor beskyttelsesmaterialet er udvalgt fra gruppen bestående af adsorbat, mikrogranulat, matrix og coating.
8. Fremgangsmåde ifølge krav 7, hvor beskyttelsesmaterialet er en coating.
9. Fremgangsmåde ifølge krav 8, hvor coatingen udgør mindst 5 vægt% af partiklen.
10. Produkt, som er fremstillet ved hjælp af fremgangsmåden ifølge et hvilket som helst af kravene 1 til 9.
DK09013477.6T 1997-04-16 1998-04-13 Hurtigt opløsende, robust doseringsform DK2147669T4 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US4324297P 1997-04-16 1997-04-16
US09/057,884 US6024981A (en) 1997-04-16 1998-04-09 Rapidly dissolving robust dosage form
EP98914665A EP0975336A4 (en) 1997-04-16 1998-04-13 RAPID RESOLVABLE STABLE PHARMACEUTICAL FORM

Publications (2)

Publication Number Publication Date
DK2147669T3 DK2147669T3 (da) 2014-11-17
DK2147669T4 true DK2147669T4 (da) 2018-03-12

Family

ID=21926209

Family Applications (2)

Application Number Title Priority Date Filing Date
DK10011802.5T DK2266538T3 (da) 1997-04-16 1998-04-13 Hurtigt opløsende, robust doseringsform
DK09013477.6T DK2147669T4 (da) 1997-04-16 1998-04-13 Hurtigt opløsende, robust doseringsform

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK10011802.5T DK2266538T3 (da) 1997-04-16 1998-04-13 Hurtigt opløsende, robust doseringsform

Country Status (10)

Country Link
US (2) US6024981A (da)
EP (3) EP0975336A4 (da)
JP (3) JP2001524956A (da)
AU (1) AU726336B2 (da)
CA (1) CA2284663C (da)
DK (2) DK2266538T3 (da)
ES (2) ES2647356T3 (da)
HK (1) HK1137654A1 (da)
PT (2) PT2147669E (da)
WO (1) WO1998046215A1 (da)

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CA2284663A1 (en) 1998-10-22
EP2147669A2 (en) 2010-01-27
EP2266538B1 (en) 2017-08-16
ES2525720T3 (es) 2014-12-29
JP2008001726A (ja) 2008-01-10
JP5072513B2 (ja) 2012-11-14
ES2647356T3 (es) 2017-12-21
AU726336B2 (en) 2000-11-02
PT2266538T (pt) 2017-11-20
EP0975336A4 (en) 2006-02-01
PT2147669E (pt) 2014-12-22
AU6896998A (en) 1998-11-11
EP2266538A3 (en) 2013-02-13
DK2147669T3 (da) 2014-11-17
CA2284663C (en) 2003-06-17
EP2147669B1 (en) 2014-10-29
HK1137654A1 (en) 2010-08-06
ES2525720T5 (es) 2018-04-05
JP2012162558A (ja) 2012-08-30
US6024981A (en) 2000-02-15
EP2147669B2 (en) 2018-01-17
WO1998046215A1 (en) 1998-10-22
DK2266538T3 (da) 2017-10-23
JP2001524956A (ja) 2001-12-04
EP2266538A2 (en) 2010-12-29
US6221392B1 (en) 2001-04-24
EP2147669A3 (en) 2010-03-10
EP0975336A1 (en) 2000-02-02

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