Testing cinnarizine solubility and dissolution in biorelevant media

Drug: cinnarizine tablets
Therapeutic category: antihistamine
Release: immediate
Type: base
Food effect: positive
BCS classification: class 2                   

A series of in vitro biorelevant dissolution tests were conducted in-house on branded cinnarizine tablets (Reference drug product: Sturgeron®) and a generic equivalent sourced from the UK to understand the influence of simulated gastrointestinal fluids on the drug's dissolution process. The biorelevant tests were developed to evaluate and compare the release rate of the generic formulation with the originator. The results strongly suggested that the drug substance and formulation were closely matched. Biorelevant media appropriate for selecting bioequivalent formulations with very similar release profiles were also identified. Additionally, the results strongly suggested that both the generic and the originator were likely to be subject to a positive food effect when the cinnarizine tablets are taken with a fatty meal.

If you would like to discuss how these type of biorelevant tests will help you accelerate the development of your test product to maximise your chances of achieving bioequivalence, please feel free to contact us here.