Document Type
Oral Presentation
Location
Oxford Conference Center, Oxford MS
Event Website
https://oxfordicsb.org/
Start Date
7-4-2025 3:30 PM
Description
Clinical studies assessing structure-function claims, safety, phytochemical pharmacokinetics, or drug interaction potential of botanical dietary supplements (BDS) often overlook the disintegration and dissolution characteristics of the administered dosage form. Consequently, inadequate disintegration or dissolution profiles may prevent key study endpoints from being met. Given the high cost of clinical research, no study should proceed without first verifying the disintegration and dissolution performance of the selected dosage form. Failure to do so may compromise the study’s validity and render its findings inconclusive. Assessing dosage form performance, particularly in biorelevant media, is a cost-effective strategy that can provide critical insights for optimizing clinical study design involving BDS. Biorelevant media are designed to mimic the physiological conditions of the stomach and small intestine in both fed and fasted states, improving the predictive accuracy of in vitro dissolution testing. Given the lipophilic nature of many phytochemicals, evaluating dissolution in biorelevant media can help determine whether a BDS should be administered with or without food to maximize bioavailability. For instance, prior to conducting a clinical study on the herb-drug interaction potential of turmeric, the disintegration and curcuminoid dissolution profiles of four commercially available turmeric-containing BDS were evaluated in four distinct biorelevant media. The results revealed significant variability in disintegration times and curcuminoid dissolution rates across the tested products. Notably, while not all product labels recommend food intake, curcuminoid dissolution was markedly higher in simulated fed gastric and intestinal conditions compared to fasted states. These findings suggest that for clinical studies involving turmeric-containing BDS, administering the dosage form with meals—preferably those rich in fat—would optimize curcuminoid bioavailability and enhance study outcomes.
Recommended Citation
Gurley, Bill, "Dosage form performance assessment of four commercially available turmeric-containing dietary supplements to inform clinical study design." (2025). Oxford ICSB. 10.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/10
Publication Date
April 2025
Accessibility Status
Screen reader accessible, Searchable text
Included in
Dosage form performance assessment of four commercially available turmeric-containing dietary supplements to inform clinical study design.
Oxford Conference Center, Oxford MS
Clinical studies assessing structure-function claims, safety, phytochemical pharmacokinetics, or drug interaction potential of botanical dietary supplements (BDS) often overlook the disintegration and dissolution characteristics of the administered dosage form. Consequently, inadequate disintegration or dissolution profiles may prevent key study endpoints from being met. Given the high cost of clinical research, no study should proceed without first verifying the disintegration and dissolution performance of the selected dosage form. Failure to do so may compromise the study’s validity and render its findings inconclusive. Assessing dosage form performance, particularly in biorelevant media, is a cost-effective strategy that can provide critical insights for optimizing clinical study design involving BDS. Biorelevant media are designed to mimic the physiological conditions of the stomach and small intestine in both fed and fasted states, improving the predictive accuracy of in vitro dissolution testing. Given the lipophilic nature of many phytochemicals, evaluating dissolution in biorelevant media can help determine whether a BDS should be administered with or without food to maximize bioavailability. For instance, prior to conducting a clinical study on the herb-drug interaction potential of turmeric, the disintegration and curcuminoid dissolution profiles of four commercially available turmeric-containing BDS were evaluated in four distinct biorelevant media. The results revealed significant variability in disintegration times and curcuminoid dissolution rates across the tested products. Notably, while not all product labels recommend food intake, curcuminoid dissolution was markedly higher in simulated fed gastric and intestinal conditions compared to fasted states. These findings suggest that for clinical studies involving turmeric-containing BDS, administering the dosage form with meals—preferably those rich in fat—would optimize curcuminoid bioavailability and enhance study outcomes.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/10