DK3143992T3 - Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid - Google Patents

Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid Download PDF

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DK3143992T3
DK3143992T3 DK16195982.0T DK16195982T DK3143992T3 DK 3143992 T3 DK3143992 T3 DK 3143992T3 DK 16195982 T DK16195982 T DK 16195982T DK 3143992 T3 DK3143992 T3 DK 3143992T3
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iron
composition
hydroxide
amount
tablet
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DK16195982.0T
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Ludwig Weibel-Furer
Erik Philipp
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Vifor Fresenius Medical Care Renal Pharma Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • 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
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    • 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
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • 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
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    • 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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • 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
    • A61K47/02—Inorganic compounds

Claims (32)

1. Farmaceutisk sammensætning omfattende jern-oxy-hydroxid i en mængde på 10 til 80 % (w/w), udtrykt i forhold til den totale vægt af sammensætningen, i en form egnet til oral administration, hvilken sammensætning omfatter en blanding af nativ og prægelatiniseret stivelse.
2. Den farmaceutiske sammensætning ifølge krav 1, hvilken omfatter en blanding af nativ og prægelatiniseret stivelse med et forhold (nativ : prægelatiniseret) i området fra 10:1 til 0,5:1, fortrinsvis i området fra 3:1 til 0,5:1 mere fortrinsvis i området fra 2:1 til 1:1.
3. Den farmaceutiske sammensætning ifølge kravene 1 eller 2, i en form egnet til oral administration som film-coatede dosisformer til intakt slugning eller som dosisformer i stand til disintegration i mundhulen.
4. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 3, hvilken er en tablet.
5. Den farmaceutiske sammensætning ifølge krav 3, hvilken er en dosisform i stand til disintegration i mundhulen eller i en lille mængde væske forud for indtagelse.
6. Den farmaceutiske sammensætning ifølge krav 5, hvor dosisformen i stand til disintegration i mundhulen er valgt fra gruppen bestående af tyggetabletter eller piller, tørre pulvere, granulater, kapsler eller poser indeholdende disse granulater, oblater, eller pastiller.
7. Den farmaceutiske sammensætning ifølge kravene 5 eller 6, hvor dosisformen i stand til disintegration i mundhulen er valgt fra tyggetabletter.
8. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 7, omfattende jern-oxy-hydroxid i en mængde på > 300 mg per dosisform.
9. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 8, omfattende jern-oxy-hydroxid i en mængde på 300 til 2000 mg per dosisform.
10. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 9, hvor den orale dosering er en tablet til intakt slugning, hvilken omfatter jern-oxy-hydroxid i en mængde på 350 til 850 mg.
11. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 9, hvor de orale dosisformer er i stand til hurtig disintegration i mundhulen eller i en lille mængde væske forud for indtagelse og hvor jern-oxy-hydroxidet er til stede i en mængde på 700 til 1700 mg per dosisform.
12. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 9, hvor jern-oxy-hydroxidet er til stede i en mængde på 800 mg per dosisform.
13. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvilken omfatter saccharose.
14. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvilken sammensætning er en tablet bestående af jern-oxy-hydroxid, saccharose, en blanding af nativ og prægelatiniseret stivelse, aromastof, sødemiddel, og glidemiddel.
15. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor jern-oxy-hydroxidet indeholder beta-jern-oxy-hydroxid.
16. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor jern-oxy-hydroxid er til stede i en mængde på 30 til 65 % (w/w), udtrykt i forhold til den totale vægt af sammensætningen.
17. Sammensætningen ifølge et hvilket som helst af de foregående krav yderligere omfattende et eller flere aromastoffer, sødemidler, smagsfremmende midler, og/eller farvestoffer.
18. Sammensætningen ifølge et hvilket som helst af de foregående krav yderligere omfattende en eller flere excipienser, såsom superdisintegranter, glidemidler, antioxidanter.
19. Sammensætningen ifølge krav 18, hvor glidemidlet er valgt fra gruppen bestående af magnesiumstearat, silika-derivater, såsom kolloid silika, pyrogen silika, hydreret natrium silico-aluminat, kolloid silicium-dioxid, talkum og blandinger deraf, fortrinsvis magnesiumstearat, kolloid silika eller talkum.
20. Sammensætningen ifølge kravene 18 eller 19, hvor glidemidlet er til stede i en mængde på 0,01 til 10 % (w/w), fortrinsvis 0,1 til 5 % (w/w), udtrykt i forhold til den totale vægt af sammensætningen.
21. Fremgangsmåde til fremstilling af sammensætningen ifølge et hvilket som helst af de foregående krav i form af en tablet ved direkte kompression eller tørgranulering.
22. Fremgangsmåde til fremstilling af sammensætningen ifølge et hvilket som helst af de foregående krav i form af en tablet, hvor en vandig suspension, omfattende mindst 90 % (w/w) af ingredienserne baseret på den totale vægt af den endelige sammensætning, fremstilles, hvilken derefter udsættes for sprøjtetørring for at opnå et flydende pulver, hvilket eventuelt blandes med de resterende ingredienser og efterfølgende komprimeres for at opnå en tablet.
23. Tablet, opnåelig med fremgangsmåden ifølge krav 21 eller 22.
24. Stabiliseret præblanding omfattende 10 til 80 % (w/w) jern-oxy-hydroxid og en blanding af nativ og prægelatiniseret stivelse.
25. Stabiliseret præblanding ifølge krav 24, omfattende 1,0 til 50 % (w/w) af stabiliseringsmidlet.
26. Stabiliseret præblanding ifølge kravene 24 eller 25, hvor blandingen af nativ og prægelatiniseret stivelse har et forhold (nativ : prægelatiniseret) i området fra 10:1 til 0,5:1, fortrinsvis i området fra 3:1 til 0,5:1 mere fortrinsvis i området fra 2:1 til 1:1.
27. Stabiliseret præblanding ifølge et hvilket som helst af kravene 24 til 26, omfattende saccharose.
28. Anvendelse af præblandingen ifølge et hvilket som helst af kravene 24 til 27 til fremstillingen afen tablet.
29. Præblandingen ifølge et hvilket som helst af kravene 24 til 27 som et flydende pulver.
30. Anvendelse af en blanding af nativ og prægelatiniseret stivelse til fremstillingen afen farmaceutisk sammensætning i formen afen tablet, omfattende jern-oxy-hydroxid i en mængde på 10 til 80 % (w/w), udtrykt i forhold til den totale vægt af sammensætningen.
31. Anvendelse af de farmaceutiske sammensætninger ifølge et hvilket som helst af de foregående krav 1 til 20 eller præblandingerne ifølge et hvilket som helst af kravene 24 til 27 til fremstillingen af et medikament til behandlingen af hyperphosphatæmi,
32. Anvendelse af de farmaceutiske sammensætninger ifølge krav 31, hvor niveauet afjern frigivet fra den farmaceutiske sammensætning er under 2,5 % w/w.
DK16195982.0T 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid DK3143992T3 (da)

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EP07120837 2007-11-16
EP08848615.4A EP2222285B1 (en) 2007-11-16 2008-11-13 Pharmaceutical compositions

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DK18191458.1T DK3492069T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid
DK21176696.9T DK3895699T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid

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US (13) US9561251B2 (da)
EP (6) EP3895700B1 (da)
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