DK2665477T3 - Modificerede frigivelsessammensætninger af epalrestat eller et derivat deraf og fremgangsmåder til anvendelse af samme - Google Patents

Modificerede frigivelsessammensætninger af epalrestat eller et derivat deraf og fremgangsmåder til anvendelse af samme Download PDF

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DK2665477T3
DK2665477T3 DK12736674.8T DK12736674T DK2665477T3 DK 2665477 T3 DK2665477 T3 DK 2665477T3 DK 12736674 T DK12736674 T DK 12736674T DK 2665477 T3 DK2665477 T3 DK 2665477T3
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epalrestat
release composition
diabetic
composition
release
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DK12736674.8T
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English (en)
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Isabel Kalofonos
William Martin-Doyle
Judy Caron
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Bionevia Pharmaceuticals Inc
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • 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
    • A61K9/14—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
    • A61K9/20—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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/282—Organic compounds, e.g. fats
    • 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
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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

Claims (15)

1. Modificeret farmaceutisk frigivelsessammensætning, omfattende: epalrestat eller et farmaceutisk acceptabelt derivat deraf; en vandopsvulmelig og pH-uafhængig polymer; en anionisk ikke-cellulosebaseret vandopsvulmelig polymer; og et sakkaridbaseret frigivelseshastighedstilpasningsmiddel.
2. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, som (i) når administreret til en patient i en regelmæssig doseringsplan, tilvejebringer en relativ flad plasmakoncentrationsprofil af epalrestat ved steady state, hvor der ikke er nogen i det væsentlige toppunkter eller lavpunkter i den relativt flade plasmakoncentrationsprofil og den minimale plasmakoncentration af epalrestat i den relativt flade plasmakoncentrationsprofil er tilstrækkelig til at tilvejebringe en terapeutisk virkning til patienten; eller (ii) når administreret til en patient i en regelmæssig doseringsplan, tilvejebringer en relativ flad plasmakoncentrationsprofil af epalrestat ved steady state således at et gennemsnitligt Cmin/Cmax epalrestat-forhold under doseringsintervallet er omkring 0,55 til omkring 1,0 og Cmin'en er tilstrækkelig til at tilvejebringe en terapeutisk virkning; eller (iii) er i en en-gang-om-dagen eller to-gange-om-dagen dosisform, tilvejebringer til en patient en terapeutisk effekt i omkring 12 til omkring 24 timer og en relativ flad plasmakoncentrationsprofil af epalrestat ved steady state således at den minimale plasmakoncentration af epalrestat under doseringsintervallet er omkring 55% af den maksimale plasmakoncentration under doseringsintervallet.
3. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, hvor den vandopsvulmelige og pH-uafhængige polymer er valgt fra gruppen bestående af hypromellose, hydroxypropylethylcelluloser, hydroxypropylcellulose, hydroxyethylcellulose, methylcellulose, og kombinationer deraf.
4. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, hvor den anioniske ikke-cellulosebaserede vandopsvulmelige polymer er valgt fra gruppen bestående af anioniske derivater af agar; anioniske derivater af guargummi; anioniske derivater af johannesbrødkernegummi; anioniske derivater af xanthangummi; anioniske derivater af alginin; anioniske derivater af polysakkarider af mannose og galaktose, eller kitosan; anioniske derivater af modificeret stivelse; og kombinationer deraf.
5. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, hvor det sakkaridbaserede frigivelseshastighedstilpasningsmiddel er en polyol-forbindelse.
6. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 5, hvor polyol-forbindelsen er valgt fra arabitol, xylitol, ribitol, mannitol, sorbitol, dulcitol, fucitol, iditol, isomalt, maltitol, og lactitiol.
7. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, hvilken er i en matrix-form, såsom en oral tablet.
8. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, hvor vægtforholdet mellem den vandopsvulmelige og pH-uafhængige polymer og den anioniske ikke-cellulosebaserede vandopsvulmelige polymer er fra omkring 2,5 : 1 til omkring 1,5 : 1.
9. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, hvor epalrestat eller et farmaceutisk acceptabelt derivat deraf er i en mængde på omkring 30 til omkring 45 vægtprocent.
10. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, hvor epalrestat eller et farmaceutisk acceptabelt derivat deraf er cholinhydrogendiepalrestat eller betainhydrogendiepalrestat.
11. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, til anvendelse i en fremgangsmåde omfattende administration til en patient en eller to gange om dagen.
12. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, til anvendelse i en fremgangsmåde til behandling af diabetes eller en diabetisk komplikation i et individ med behov derfor.
13. Den modificerede farmaceutiske frigivelsessammensætning til anvendelsen ifølge krav 12, omfattende administration til en patient en eller to gange om dagen.
14. Den modificerede farmaceutiske frigivelsessammensætning til anvendelsen ifølge krav 12, hvor den diabetiske komplikation er valgt fra gruppen bestående af diabetisk neuropati, diabetisk nephropati, diabetisk kardiomyopati, diabetisk retinopati, diabetisk gastroparese, katarakt, fodsår, diabetisk macroangiopati, diabetisk microangiopati, højt blodsukker, høje HbAlc-niveauer, og kombinationer deraf.
15. Den modificerede farmaceutiske frigivelsessammensætning ifølge krav 1, til anvendelse i en fremgangsmåde til at inhibere aldose-reduktase i et individ med behov derfor; eller til anvendelse i kardiobeskyttelse i et individ med behov derfor.
DK12736674.8T 2011-01-20 2012-01-20 Modificerede frigivelsessammensætninger af epalrestat eller et derivat deraf og fremgangsmåder til anvendelse af samme DK2665477T3 (da)

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US201161434637P 2011-01-20 2011-01-20
PCT/US2012/022094 WO2012100208A1 (en) 2011-01-20 2012-01-20 Modified release compositions of epalrestat or a derivative thereof and methods for using the same

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US (2) US9566269B2 (da)
EP (2) EP2665477B1 (da)
CY (1) CY1117483T1 (da)
DK (1) DK2665477T3 (da)
ES (1) ES2555927T3 (da)
HK (1) HK1191569A1 (da)
HR (1) HRP20151321T1 (da)
HU (1) HUE026715T2 (da)
PL (1) PL2665477T3 (da)
PT (1) PT2665477E (da)
RS (1) RS54447B1 (da)
RU (2) RU2017124629A (da)
SI (1) SI2665477T1 (da)
SM (1) SMT201500307B (da)
WO (1) WO2012100208A1 (da)

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WO2012100208A1 (en) 2012-07-26
PL2665477T3 (pl) 2016-05-31
EP2665477B1 (en) 2015-09-09
ES2555927T3 (es) 2016-01-11
EP3042654A1 (en) 2016-07-13
PT2665477E (pt) 2016-01-12
US20180000792A1 (en) 2018-01-04
RU2017124629A (ru) 2019-01-30
HUE026715T2 (en) 2016-07-28
US20140296309A1 (en) 2014-10-02
CY1117483T1 (el) 2017-04-26
SMT201500307B (it) 2016-02-25
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EP2665477A1 (en) 2013-11-27
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RS54447B1 (en) 2016-06-30

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