Testing cinnarizine solubility and dissolution in biorelevant media
Drug: cinnarizine tablets
Therapeutic category: antihistamine
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.
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