Unilever’s Use Of Biorelevant Media
Biorelevant Media can assist with the development of your oral dosage form and Unilever’s study on capsule shell material can help show you how¹.
The team at Unilever looked at how materials that make up capsules interact with a specific green tea extract. They looked at the effects of these interactions between the external materials (gelatin or a polymer called HPMC) and the green tea extract by doing disintegration and dissolution testing.
Unilever’s dissolution testing (USP 2 apparatus) comprised compendial media and our very own Biorelevant Media to compare their predictive power looking at 135 existing human trials with green tea extract. Biorelevant Media were able to predict in vitro the performance of these capsules in vivo (i.e. gelatin presents better performance than HPMC). In this paper the authors endorse the use of Biorelevant Media and general dissolution testing:
“Data from dissolution in FaSSIF and FeSSIF are especially valuable to plan the time of administration, e.g. whether to dose with or without a meal… in order to properly design and guide nutrition intervention trials and to enhance the success rate of an investigational product or dietary supplement, a good understanding of the formulation’s in vitro performance is crucial, as the release profiles will greatly affect the timings of clinical measurements”. – Unilever
If you want to learn more about this study, we strongly recommend that you have a read through the original article (see reference below).
1. Glube, N., Moos, L. von & Duchateau, G. Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract. Results Pharma Sci. 3, 1–6 (2013).