DK2659881T3 - Lægemiddelformulering med forsinket udløsning - Google Patents

Lægemiddelformulering med forsinket udløsning Download PDF

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DK2659881T3
DK2659881T3 DK12166110.2T DK12166110T DK2659881T3 DK 2659881 T3 DK2659881 T3 DK 2659881T3 DK 12166110 T DK12166110 T DK 12166110T DK 2659881 T3 DK2659881 T3 DK 2659881T3
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Denmark
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polymeric material
coating
delayed release
polymer
core
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DK12166110.2T
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Thomas Buser
Frederic Jean Claude Goutte
Abdul Waseh Basit
Ana Cristina Freire
Felipe Jose Oliveira Varum
Gonzales Roberto Carlos Bravo
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Tillotts Pharma Ag
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    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
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    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
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Claims (16)

  1. Lægemiddelformulering med forsinket udløsning Patentkrav
    1. Lægemiddelformulering med forsinket udløsning til oral administration til tilførsel af et lægemiddel til kolon hos et subjekt, hvilken formulering omfatter en kerne og en belægning til kernen, hvor kernen omfatter et lægemiddel, og belægningen omfatter et udvendigt lag og et indvendigt lag, hvori det udvendige lag omfatter en blanding af et første polymerisk materiale, som er modtageligt over for angreb fra kolonbakterier, og et andet polymerisk materiale, som har en pH-tærskelværdi på pH 6,5 eller derover, og hvori det indvendige lag omfatter et tredje polymerisk materiale, som er opløseligt i tarmvæske, hvilken tredje polymer er en polycarboxylsyre-polymer som mindst er delvis neutraliseret, hvori mindst 10 % af polycarboxylsyrc-polymerens carboxylsyregrupper er i form af carboxylat-anioner.
  2. 2. Lægemiddelformulering med forsinket udløsning ifølge krav 1, hvori mindst 90 % af polycarboxylsyre-polymerens carboxylsyregrupper er i form af carboxylat-anioner.
  3. 3. Lægemiddelformulering med forsinket udløsning ifølge krav 1 eller krav 2, hvori det tredje polymeriske materiale er fuldt ud neutraliseret.
  4. 4. Lægemiddelformulering med forsinket udløsning ifølge et hvilket som helst af kravene 1 til 3, hvori det andet og tredje polymeriske materiale er baseret på samme polycarboxylsyre-polymer, hvor det tredje polymeriske materiale har en højere grad af neutralisering end det andet polymeriske materiale.
  5. 5. Lægemiddelformulering med forsinket udløsning ifølge et hvilket som helst af de foregående krav, hvori det tredje polymeriske materiale er udvalgt fra polymethacrylater; celluloseacetatphthaiat (CAP); polyvinylacetatphthaiat (PVAP); hydroxypropylmethylcellulosephthaiat (HPMCP); hydroxypropylmethylcelluloseacetatsuccinat (HPMC-AS); celluloseacetattrimellitat (CAT); xanthangummi; alginater og shellak.
  6. 6. Lægemiddelformulering med forsinket udløsning ifølge et hvilket som helst af de foregående krav, hvori det tredje polymeriske materiale er en i det mindste delvis neutraliseret co-polymer af (meth)acrylsyre og en (meth)acrylsyre C1-4 alkylester.
  7. 7. Lægemiddelformulering med forsinket udløsning ifølge et hvilket som helst af de foregående krav, hvori det tredje polymeriske materiale er en fuldt ud neutraliseret copolymer af (meth)acrylsyre og (meth)acrylsyre C1-4 alkylester.
  8. 8. Lægemiddelformulering med forsinket udløsning ifølge et hvilket som helst af de foregående krav, hvori det indvendige lag omfatter et buffermiddel udvalgt fra et uorganisk salt eller en farmakologisk acceptabel carboxylsyre med fra 1 til 16 carbonatomer.
  9. 9. Lægemiddelformulering med forsinket udløsning ifølge et hvilket som helst af de foregående krav, hvori det indvendige lag omfatter en farmakologisk acceptabel base udvalgt fra en uorganisk base eller en fysiologisk tolereret amin.
  10. 10. Lægemiddelformulering med forsinket udløsning ifølge et hvilket som helst af de foregående krav, hvori det tredje polymeriske materiale er opløseligt i vand uafhængigt af pH.
  11. 11. Fremgangsmåde til fremstilling af en lægemiddelformulering med forsinket udløsning til oral administration til tilførsel af et lægemiddel til kolon ifølge krav 1, hvilken fremgangsmåde omfatter: dannelse af en kerne omfattende et lægemiddel; belægning af kernen ved anvendelse af et indvendigt belægningspræparat omfattende et tredje polymerisk materiale, der er opløseligt i tarmvæske, i et solventsystem, så der dannes en indvendig belagt kerne og belægning af den indvendige belagte kerne med et udvendigt belægningspræparat omfattende et første polymerisk materiale, som er modtageligt over for angreb fra kolonbakterier, og et andet polymerisk materiale, som har en pH-tærskelværdi på pH 6,5 eller derover i et solventsystem, så der dannes en udvendig belagt kerne; hvori det tredje polymeriske materiale er en polycarboxylsyre-polymer, der mindst er delvis neutraliseret, hvori mindst 10 % af polycarboxylsyrc-polymerens carboxylsyregrupper er i form af carboxylat-anioner.
  12. 12. Fremgangsmåde ifølge krav 11, hvori det indvendige belægningspræparats solventsystem er vandigt.
  13. 13. Fremgangsmåde ifølge krav 11 eller krav 12, hvilken fremgangsmåde omfatter dispergering af en polycarboxylsyre-polymer i et solvent, eventuelt med et buffermiddel, og tilsætning af base for i det mindste delvis at neutralisere polycarboxylsyre-polymeren, så der dannes et indvendigt belægningspræparat.
  14. 14. Fremgangsmåde ifølge krav 13, hvori mængden af tilsat base mindst er tilstrækkelig til at neutralisere mindst 90 % af carboxylsyregruppeme i polycarboxylsyre-polymeren.
  15. 15. Fremgangsmåde ifølge krav 13 eller krav 14, hvori mængden af tilsat base er mere end tilstrækkelig til fuldt ud at neutralisere polycarboxylsyre-polymeren.
  16. 16. Fremgangsmåde ifølge et hvilket som helst af kravene 11 til 15, hvori pH i det indvendige belægningspræparat justeres til at være fra pH 7,5 til pH 10.
DK12166110.2T 2012-04-30 2012-04-30 Lægemiddelformulering med forsinket udløsning DK2659881T3 (da)

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EP12166110.2A EP2659881B1 (en) 2012-04-30 2012-04-30 A delayed release drug formulation

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DK17156227.5T DK3189830T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning
DK13719543.4T DK2844220T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning
DK17188821.7T DK3278792T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning
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