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To clinically assess the efficacy of DRcaps® capsules for resistance to stomach acids for delayed delivery properties of ingredients, Capsugel commissioned an independent laboratory to conduct a gamma scintigraphic study.
The study was designed to investigate the in vivo behavior of unbanded DRcaps® capsules using qualitative and quantitative scintigraphic methods to assess the GI transit of DRcaps® capsules and the release of capsule contents based on the scintigraphic images obtained.
Each subject consumed a light breakfast approximately 30 minutes prior to dosing a DRcaps® capsule containing 300mg of lactose, 10mg of which was radiolabelled. Anterior and posterior images were taken after dosing and then every 5 minutes up to 4 hours post-dose.