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DK2364360T3 - Antisense-sammensætninger og fremgangsmåder til fremstilling og anvendelse deraf - Google Patents

Antisense-sammensætninger og fremgangsmåder til fremstilling og anvendelse deraf Download PDF

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Publication number
DK2364360T3
DK2364360T3 DK09756431.4T DK09756431T DK2364360T3 DK 2364360 T3 DK2364360 T3 DK 2364360T3 DK 09756431 T DK09756431 T DK 09756431T DK 2364360 T3 DK2364360 T3 DK 2364360T3
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Prior art keywords
tablet formulation
weight
pharmaceutical tablet
antisense oligonucleotide
approx
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DK09756431.4T
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English (en)
Inventor
Sergio Baroni
Salvatore Bellinvia
Francesca Viti
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Nogra Pharma Ltd
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    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7105—Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7125—Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/713—Double-stranded nucleic acids or oligonucleotides
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C—CHEMISTRY; METALLURGY
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C12N15/1136—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing against growth factors, growth regulators, cytokines, lymphokines or hormones
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    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/11—Antisense
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    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/30—Chemical structure
    • C12N2310/31—Chemical structure of the backbone
    • C12N2310/315—Phosphorothioates
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications
    • C12N2320/32—Special delivery means, e.g. tissue-specific

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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (19)

1. Farmaceutisk tabletformulering til oral administration af et antisense-oligonukleotid omfattende: en intra-granulær fase omfattende et antisense-oligonukleotid vist med SEQ ID NO 1 eller et farmaceutisk acceptabelt salt deraf og et farmaceutisk acceptabelt fyldstof; en ekstra-granulær fase omfattende et disintegrant; og en enterisk coating omfattende en ethylacrylat-methacrylsyre-copolymer, hvor når den testet i et USP/EP Type 2-apparat (skovl) ved 100 omdr/min og 37°C i en phosphatbuffer med en pH på 6,6 ikke mere end ca. 50% af mængden af antisense-oligonukleotidet frigives fra den farmaceutiske tabletformulering over en periode på 30 minutter og når testet i et USP/EP Type 2-apparat (skovl) ved 100 omdr/min og 37°C i fortyndet HCI med en pH på 1,0 i det væsentlige intet af mængden af antisense-oligonukleotidet frigives fra den farmaceutiske tabletformulering over en periode på 120 minutter, og hvor formuleringen leverer antisense-forbindelsen til slutileum og højre tyktarm på en patient.
2. Farmaceutisk tabletformulering ifølge krav 1, hvor internukleotidbindinger af SEQ ID NO 1 er Ο,Ο-bundne phosphorthioater.
3. Farmaceutisk tabletformulering ifølge krav 1 eller 2, hvor antisense-oligonukleotidet er natriumsaltet af SEQ ID NO 1.
4. Farmaceutisk tabletformulering ifølge et hvilket som helst af kravene 1-3, hvor den intra-granulære fase yderligere omfatter et disintegrant og/eller den ekstra-granulære fase yderligere omfatter enlubrikant.
5. Farmaceutisk tabletformulering ifølge krav 4, hvor lubrikanten er natriumstivelsesglycolat.
6. Farmaceutisk tabletformulering ifølge et hvilket som helst af kravene 1-5, hvor fyldstoffet er mannitol, og/eller disintegranteter natriumstivelsesglycolat.
7. Farmaceutisk tabletformulering ifølge et hvilket som helst af kravene 1-6, hvor den intra-granulære fase yderligere omfatter en komponent valgt fra mikrokrystallinsk cellulose, natriumstivelsesglycolat, hydroxypropylmethyl cellulose, og blandinger deraf og/eller den ekstra-granulære fase yderligere omfatter en komponent valgt fra mikrokrystallinsk cellulose og magnesiumstearat, og blandinger deraf.
8. Farmaceutisk tabletformulering ifølge et hvilket som helst af kravene 1-7 hvor den enteriske coating er 8 til 18%, af tablettens vægt.
9. Farmaceutisk tabletformulering ifølge krav 1 omfattende: 0,5 til 10 vægtprocent af et antisense-oligonukleotid vist med SEQ ID NO 1 eller et farmaceutisk acceptabelt salt deraf; 30 til 50 vægtprocent mannitol; og 10 til 30 vægtprocent mikrokrystallinsk cellulose.
10. Farmaceutisk tabletformulering ifølge krav 1 omfattende 35 mg til 500 mg af antisense-oligonukleotidet vist med SEQ ID NO 1 eller et farmaceutisk acceptabelt salt deraf.
11. Farmaceutisk tabletformulering ifølge krav 1 omfattende: en intra-granulær fase omfattende: 5 til 10 vægtprocent antisense-oligonukleotidet vist med SEQ ID NO 1 eller et farmaceutisk acceptabelt salt deraf; ca. 40 vægtprocent mannitol, ca. 8 vægtprocent mikrokrystallinsk cellulose, ca. 5 vægtprocent hydroxypropylmethyl cellulose, og ca. 2 vægtprocent natriumstivelsesglycolat; og en ekstra-granulær fase omfattende: ca. 17 vægtprocent mikrokrystallinsk cellulose, ca. 2 vægtprocent natriumstivelsesglycolat, og ca. 0,4 vægtprocent magnesiumstearat.
12. Farmaceutisk tabletformulering ifølge krav 10, med ca. 40 mg af antisense-nukleotidet.
13. Farmaceutisk tabletformulering ifølge et hvilket som helst af kravene 1-12 til anvendelse i behandling af Crohn's sygdom, ulcerativ colitis eller kronisk inflammatorisk tarmsygdom.
14. Farmaceutisk tabletformulering ifølge krav 1, hvor den farmaceutiske tabletformulering omfatter 0,5 til 70 vægtprocent af et antisense-oligonukleotid vist med SEQ ID NO: 1 eller et farmaceutisk acceptabelt salt deraf; 0,5 til 60 vægtprocent mannitol; 20 til 40 vægtprocent mikrokrystallinsk cellulose.
15. Farmaceutisk tabletformulering ifølge krav 14, hvor den farmaceutiske tabletformulering omfatter 5 til 20 vægtprocent af den enteriske coating.
16. Farmaceutisk tabletformulering ifølge krav 14, hvor den farmaceutiske tabletformulering omfatter 8 til 18 vægtprocent af den enteriske coating.
17. Farmaceutisk tabletformulering ifølge krav 14, hvor den farmaceutiske tabletformulering omfatter 8 til 15 vægtprocent af den enteriske coating.
18. Farmaceutisk tabletformulering ifølge krav 14, hvor den farmaceutiske tabletformulering omfatter 12 til 16 vægtprocent af den enteriske coating.
19. Farmaceutisk tabletformulering ifølge krav 14, hvor den farmaceutiske tabletformulering omfatter ca. 13%, ca. 15%, ca. 16%, eller ca. 17 vægtprocent af den enteriske coating.
DK09756431.4T 2008-11-13 2009-11-13 Antisense-sammensætninger og fremgangsmåder til fremstilling og anvendelse deraf DK2364360T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08425727 2008-11-13
US15229709P 2009-02-13 2009-02-13
PCT/EP2009/008087 WO2010054826A1 (en) 2008-11-13 2009-11-13 Antisense compositions and methods of making and using same

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DK2364360T3 true DK2364360T3 (da) 2017-06-19

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DK16187284.1T DK3121280T3 (da) 2008-11-13 2009-11-13 Antisense-sammensætninger og fremgangsmåder til fremstilling og anvendelse deraf
DK09756431.4T DK2364360T3 (da) 2008-11-13 2009-11-13 Antisense-sammensætninger og fremgangsmåder til fremstilling og anvendelse deraf

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US (7) US8912154B2 (da)
EP (2) EP3121280B1 (da)
JP (7) JP5719776B2 (da)
KR (2) KR101767145B1 (da)
CN (2) CN102216458B (da)
AU (4) AU2009315898B2 (da)
CA (2) CA3085272A1 (da)
CY (1) CY1119140T1 (da)
DK (2) DK3121280T3 (da)
ES (2) ES2627745T3 (da)
FI (1) FI3121280T3 (da)
HR (2) HRP20170926T1 (da)
HU (2) HUE032368T2 (da)
LT (2) LT3121280T (da)
MX (3) MX2011005042A (da)
NZ (1) NZ592673A (da)
PL (2) PL3121280T3 (da)
PT (2) PT3121280T (da)
RS (2) RS56049B1 (da)
RU (2) RU2739302C2 (da)
SI (2) SI3121280T1 (da)
SM (2) SMT202500239T1 (da)
WO (1) WO2010054826A1 (da)

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