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DRcaps® Capsules: Proven Targeted Release for Acid-Sensitive Ingredients
DRcaps® Capsules Disintegration Performance in Human Subjects
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.
Key Study Results
DRcaps™ in vivo disintegration
- DRcaps® capsules displayed delayed release properties
- Disintegration started approximately 45 minutes later than a typical immediate release capsule of about 5 minutes
- For the majority of subjects, complete release took place in the intestine
- Complete release occurred 20 minutes after the onset of release
- DRcaps® capsules significantly reduced opportunity for nutritional ingredient degradation compared with standard immediate release capsules