Pharmaceutical compositions comprising eluxadoline

摘要

Eluxadoline (previously known as JNJ-27018966) is a locally acting, mixed mu opioid receptor (μOR) agonist and de Ita opioid receptor (δOR) antagonist. The full chemical name is 5-111(2S)-2-amino-3-[4-(aminiocarbonyl)-2,6-diinothylpheny!]-i-oxopropyl][(lS)- l-(4-phenyl- 1H-imidaaol-2-yl)ethyl]amino|methyl]-2-methoxybenzoic acid. Eluxadoline has been approved by the US FDA as VIBERZI® on May 27, 2015. VIBERZI® is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). In Europe, it was approved in September 2016 by the EMA as TRUBERZ® for the same indication. VIBERZI® / TRUBERZI® is available as 75 mg and 100 mg tablets for oral administration. The tablets contain 75 mg or 100 mg eluxadoline, silicified microcrystatltnc cellulose (filler), colloidal silica, crospovidone type B (disintegrant), mannitol (filler), magnesium stearate (lubricant), and a Opadry® II coating (containing partially hydrolyzed poly vinyl alcohol titanium dioxide, polyethylene glycol. talc, iron oxide yellow, and iron oxide red).