DK2637646T3 - Farmaceutisk kombination indeholdende en ibat-inhibitor og et galdesyrebindemiddel - Google Patents

Farmaceutisk kombination indeholdende en ibat-inhibitor og et galdesyrebindemiddel Download PDF

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DK2637646T3
DK2637646T3 DK11840481.3T DK11840481T DK2637646T3 DK 2637646 T3 DK2637646 T3 DK 2637646T3 DK 11840481 T DK11840481 T DK 11840481T DK 2637646 T3 DK2637646 T3 DK 2637646T3
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phenyl
carbamoyl
methylthio
dibutyl
dioxo
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Per-Göran Gillberg
Hans Graffner
Ingemar Starke
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Albireo Ab
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Claims (16)

1. Kombination indeholdende en IBAT-inhibitor med formlen II
Formel II i hvilken Mer -CH2 eller NH; R1 er H eller OH; og R2 er H, -CH3, -CH2CH3, -CH2CH2CH3, -CH2CH2CH2CH3, -CH(CH3)2, -CH2CH(CH3)2, -CH(CH3)CH2CH3, -CH2OH, CH2OCH3, -CH(OH)CH3j -CH2SCH3 eller -CH2CH2-S-CH3; eller et farmaceutisk acceptabelt salt deraf, og et galdesyrebindemiddel, til samtidig, sekventiel eller særskilt indgivelse, hvor galdesyrebindemidlet er formuleret til frigivelse i colon, til anvendelse ved behandling afen leversygdom valgt fra gruppen bestående af primær biliær cirrhose (PBC); progressiv familiær intrahepatisk cholestase (PFIC); Alagilles syndrom (ALGS); primær skleroserende cholangitis (PSC); ikke-alkoholisk steatohepatitis (NASH); og pruritus ved cholestatisk leversygdom.
2. Kombination til anvendelse ifølge krav 1, hvor leversygdommen er primær biliær cirrhose (PBC).
3. Kombination til anvendelse ifølge krav 1, hvor leversygdommen er progressiv familiær intrahepatisk cholestase (PFIC).
4. Kombination til anvendelse ifølge krav 1, hvor leversygdommen er Alagilles syndrom (ALGS).
5. Kombination til anvendelse ifølge krav 1, hvor leversygdommen er primær skleroserende cholangitis (PSC).
6. Kombination til anvendelse ifølge krav 1, hvor leversygdommen er ikke-alkoholisk steatohepatitis (NASH).
7. Kombination til anvendelse ifølge krav 1, hvor leversygdommen er pruritus ved cholestatisk leversygdom.
8. Kombination til anvendelse ifølge ethvert af kravene 1 til 7, hvor kombinationen er udformet til afgivelse af IBAT-inhibitoren i tyndtarmen og galdesyrebindemidlet i colon.
9. Kombination til anvendelse ifølge ethvert af kravene 1 til 8, hvori forbindelsen med formlen (II) er valgt fra gruppen bestående af: 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-a-[N-(carboxymethyl)carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-a-[N'-((S)-1-carboxyethyl) carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,5-benzothiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(A/-{(R)-a-[A/-((S)-1 -carboxypropyl) carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((R)-1-carboxy-2-methylthioethyl)carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((R)-1-carboxy-2-methylthio-ethyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxy-2-methylpropyl)carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxy-2-(R)-hydroxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/V-((S)-1 -carboxybutyl) carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(A/-{(R)-a-[A/-((S)-1 -carboxyethyl) carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8- (N-{(R)-a-[N'-((S)-1-carboxypropyl) carbamoyl]-4-hydroxybenzyl} carbamoylmethoxy)-2,3,4,5-tetrahydro-1,5-benzothiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxyethyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxy-2-methylpropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; og 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-1'-phenyl-1'-[N'-(carboxymethyl)carbamoyl]methyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,5-benzothiazepin, eller et farmaceutisk acceptabelt salt deraf.
10. Kombination til anvendelse ifølge krav 9, hvori forbindelsen med formlen (II) er 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1-carboxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin eller et farmaceutisk acceptabelt salt deraf.
11. Kombination til anvendelse ifølge ethvert af kravene 1 til 10, hvori galdesyrebindemidlet er cholestyramin, cholestipol eller colesevelam.
12. Farmaceutisk sammensætning indeholdende en IBAT-inhibitor med formlen II
Formel II i hvilken Mer -CH2 eller NH; R1 er Fl eller OFI; og R2 er H, -CH3, -CH2CH3, -CH2CH2CH3, -CH2CH2CH2CH3, -CH(CH3)2, -CH2CH(CH3)2, -CH(CH3)CH2CH3j -CH2OH, CH2OCH3j -CH(OH)CH3j -CFI2SCFI3 eller -CFI2CFI2-S-CFI3; eller et farmaceutisk acceptabelt salt deraf og et galdesyrebindemiddel, hvor galdesyrebindemidlet er i kernen og formuleret til frigivelse i colon, og hvor IBAT-inhibitoren er i et ydre lag formuleret til umiddelbar frigivelse eller til forsinket frigivelse i den distale jejunum eller den proximale ileum, til anvendelse ved behandling afen leversygdom valgt fra gruppen bestående af primær biliær cirrhose (PBC); progressiv familiær intrahepatisk cholestase (PFIC); Alagilles syndrom (ALGS); primær skleroserende cholangitis (PSC); ikke-alkoholisk steatohepatitis (NASFI); og pruritus ved cholestatisk leversygdom.
13. Formulering til anvendelse ifølge krav 12, indeholdende (i) en indre kerne indeholdende et galdesyrebindemiddel; (ii) et colonfrigivelseslag på kernen; (iii) et IBAT-inhibitorlag på colonfrigivelseslaget; og (iv) et ydre beskyttende overtræk.
14. Formulering til anvendelse ifølge krav 12 eller 13, hvori IBAT-inhibitorlaget indeholder en forbindelse valgt fra gruppen bestående af: 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-a-[N-(carboxymethyl)carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-a-[N'-((S)-1-carboxyethyl) carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,5-benzothiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(A/-{(R)-a-[A/-((S)-1 -carboxypropyl) carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((R)-1-carboxy-2-methylthioethyl)carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxypropyl) carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((R)-1-carboxy-2-methylthio-ethyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/V-((S)-1 -carboxy-2-methylpropyl)carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(A/-{(R)-a-[A/-((S)-1 -carboxy-2-(R)-hydroxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxybutyl) carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxyethyl) carbamoyl]benzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-a-[N'-((S)-1-carboxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,5-benzothiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/\/-((S)-1 -carboxyethyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; 1.1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[/V-((S)-1 -carboxy-2-methylpropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin; og 1.1- dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-1'-phenyl-1'-[N'-(carboxymethyl)carbamoyl]methyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,5-benzothiazepin, eller et farmaceutisk acceptabelt salt deraf.
15. Formulering til anvendelse ifølge krav 14, hvori IBAT-inhibitorlaget indeholder forbindelsen 1,1 -dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(/V-{(R)-a-[A/-((S)-1-carboxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin eller et farmaceutisk acceptabelt salt deraf.
16. Formulering til anvendelse ifølge ethvert af kravene 12 til 15, hvori galdesyrebindemidlet er cholestyramin, cholestipol eller colesevelam.
DK11840481.3T 2010-11-08 2011-11-08 Farmaceutisk kombination indeholdende en ibat-inhibitor og et galdesyrebindemiddel DK2637646T3 (da)

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MY180164A (en) 2020-11-24
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EP2637646B1 (en) 2016-05-11
AU2011326872A1 (en) 2013-04-11
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US20130236541A1 (en) 2013-09-12
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