AMITIZA (lubiprostone) is chemically designated as (–)-7-[(2R,4aR,5R,7aR)-2-(1,1- difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C₂₀H₃₂F₂O₅ with a molecular weight of 390.46 and a chemical structure as follows:

Lubiprostone drug substance occurs as white, odorless crystals or crystalline powder, is very soluble in ether and ethanol, and is practically insoluble in hexane and water. AMITIZA is available for oral administration in an imprinted, oval, orange, soft gelatin capsule containing 24 mcg lubiprostone and the following inactive ingredients: medium-chain triglycerides, gelatin, sorbitol, FD&C Red #40, D&C Yellow #10, and purified water.

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