DK2568988T3 - Farmaceutiske formuleringer omfattende 1-(beta-d-glucopyranosyl)-2-thienylmethylbenzen-derivater som inhibitorer af sglt - Google Patents

Farmaceutiske formuleringer omfattende 1-(beta-d-glucopyranosyl)-2-thienylmethylbenzen-derivater som inhibitorer af sglt Download PDF

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DK2568988T3
DK2568988T3 DK11721616.8T DK11721616T DK2568988T3 DK 2568988 T3 DK2568988 T3 DK 2568988T3 DK 11721616 T DK11721616 T DK 11721616T DK 2568988 T3 DK2568988 T3 DK 2568988T3
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Wenhua Wang
Todd Outwin
Thomas C Joseph
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Janssen Pharmaceutica Nv
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Claims (16)

1. Oral administrerbar farmaceutisk formulering omfattende en (a) forbindelse med formel (I)
hvor Ri er halo, eller en Ci-ealkylgruppe; og R2 er phenyl, hvor phenyl eventuelt er substitueret med 1 til 3 substituenter valgt fra gruppen bestående af halo, en cyanogruppe, en Ci-ealkylgruppe, en halo-Ci-ealkylgruppe, en Ci-6alkoxygruppe, en halo-Ci-6alkoxygruppe, en methylendioxygruppe, en ethylenoxygruppe, en mono-Ci-ealkyl eller di-Ci-ealkylaminogruppe, en carbamoylgruppe, og en mono-Ci-ealkyl eller di-Ci-ealkyl carbamoylgruppe; hvor halo er chlor, brom, iod, eller fluor; eller et farmaceutisk acceptabelt salt deraf; (b) et fortyndingsmiddel eller fyldstof omfattende en kombination af mikrokrystallinsk cellulose og lactose; (c) mindst én disintegrant omfattende croscarmellosenatrium; (d) mindst ét bindemiddel omfattende hydroxypropylcellulose; og (e) mindst ét smøremiddel omfattende magnesiumstearat; hvor forbindelsen med formel (I) er til stede i en mængde indenfor området på fra 1 til 80 vægtprocent; fortyndingsmidlet eller fyldstoffet er til stede i en mængde indenfor området på fra 10 til 95 vægtprocent; disintegranten er til stede i en mængde indenfor området på fra 0,1 til 20 vægtprocent; bindemidlet er til stede i en mængde indenfor området på fra 0,1 til 20 vægtprocent; og smøremidlet er til stede i en mængde indenfor området på fra 0,1 til 5 vægtprocent, alle af de ovenfor nævnte vægtprocenter er baseret på vægten af formuleringen.
2. Den farmaceutiske sammensætning ifølge krav 1, hvor fortyndingsmidlet eller fyldstoffet er til stede i en mængde indenfor området på fra 30 til 50 vægtprocent.
3. Den farmaceutiske sammensætning ifølge krav 1, hvor forbindelsen med formel (I) er til stede i en mængde indenfor området på fra 40 til 60 vægtprocent.
4. Den farmaceutiske sammensætning ifølge krav 1, hvor forbindelsen med formel (I) er: l-(3-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorphenyl)-2- thienylmethyljbenzen); eller et farmaceutisk acceptabelt salt deraf.
5. Den farmaceutiske sammensætning ifølge krav 4, hvor forbindelsen er til stede i en mængde på 25 mg til 600 mg.
6. Den farmaceutiske sammensætning ifølge krav 4, hvor forbindelsen er til stede i en mængde på 50 mg til 300 mg.
7. Den farmaceutiske sammensætning ifølge krav 4, hvor forbindelsen er til stede i en mængde på 100 mg.
8. Den farmaceutiske sammensætning ifølge krav 4, hvor forbindelsen er til stede i en mængde på 300 mg.
9. Den farmaceutiske sammensætning ifølge krav 1, hvor forbindelsen er l-(3-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorphenyl)-2-thienylmethyl]benzen) hemihydrate.
10. Den farmaceutiske sammensætning ifølge krav 4 til anvendelse i en fremgangsmåde til behandling af en natrium-afhængig glucosetransporter-medieret lidelse.
11. Den farmaceutiske sammensætning ifølge krav 10, hvor forbindelsen administreres ved en dosis på fra 50 mg til 300 mg én gang dagligt.
12. Den farmaceutiske sammensætning ifølge krav 10, hvor forbindelsen administreres ved en dosis på 100 mg pr. dag.
13. Den farmaceutiske sammensætning ifølge krav 10, hvor forbindelsen administreres ved en dosis på 300 mg pr. dag.
14. Oralt administrerbar farmaceutisk formulering ifølge krav 1 omfattende (a) l-(3-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorphenyl)-2-thienylmethyl]benzen), eller et farmaceutisk acceptabelt salt deraf der er til stede i en mængde indenfor området på fra 40 til 60 vægtprocent; (b) et fortyndingsmiddel eller fyldstof omfattende en kombination af mikrokrystallinsk cellulose og lactose til stede i en mængde indenfor området på fra 30 til 50 vægtprocent; (c) mindst én disintegrant i en mængde indenfor området på fra 3 til 10 vægtprocent; (d) mindst ét bindemiddel til stede i en mængde indenfor området på fra 0,5 til 5 vægtprocent; og (e) mindst ét smøremiddel til stede i en mængde indenfor området på fra 0,5 til 2 vægtprocent; hvor vægtprocenten er baseret på vægten af formuleringen.
15. Den farmaceutiske sammensætning ifølge krav 14, hvor forbindelsen er l-(3-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorphenyl)-2-thienylmethyl]benzen)hemihydrat.
16. Den farmaceutiske formulering ifølge et hvilket som helst af kravene 1 til 15, hvor formuleringen er en tablet.
DK11721616.8T 2010-05-11 2011-05-11 Farmaceutiske formuleringer omfattende 1-(beta-d-glucopyranosyl)-2-thienylmethylbenzen-derivater som inhibitorer af sglt DK2568988T3 (da)

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US33349510P 2010-05-11 2010-05-11
PCT/US2011/036038 WO2011143296A1 (en) 2010-05-11 2011-05-11 Pharmaceutical formulations comprising 1 - (beta-d-glucopyranosyl) - 2 -thienylmethylbenzene derivatives as inhibitors of sglt

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KR (1) KR101931209B1 (da)
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US9056850B2 (en) * 2008-10-17 2015-06-16 Janssen Pharmaceutica N.V. Process for the preparation of compounds useful as inhibitors of SGLT
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TWI542596B (zh) 2011-05-09 2016-07-21 健生藥品公司 （２ｓ,３ｒ,４ｒ,５ｓ,６ｒ）－２－（３－（（５－（４－氟苯基）噻吩－２－基）甲基）－４－甲基苯基）－６－（羥甲基）四氫－２ｈ－哌喃－３,４,５－三醇之ｌ－脯胺酸及檸檬酸共晶體
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US20170071970A1 (en) 2015-09-15 2017-03-16 Janssen Pharmaceutica Nv Co-therapy comprising canagliflozin and phentermine for the treatment of obesity and obesity related disorders
WO2019046659A1 (en) * 2017-08-30 2019-03-07 First Fruits Business Ministry, Llc COMPOSITION AND METHOD FOR INCREASING SERIAL ADIPONECTIN AND REDUCING THE LIPID RESERVES OF THE ORGANISM
CN108078945B (zh) * 2018-01-12 2020-09-11 杭州中美华东制药有限公司 卡格列净药物组合物
US11857559B2 (en) 2018-09-10 2024-01-02 Aurobindo Pharma Ltd. Pharmaceutical composition comprising Canagliflozin, process of preparation and use thereof
CN111773194B (zh) * 2019-04-04 2023-06-30 常州恒邦药业有限公司 一种卡格列净片剂及其制备方法
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