Background The development of experimental medicine (EM) for clinical trials is a tedious but lucrative activity for hospital pharmacies. This activity requires the compounding of poorly described compounds with often unfavourable biopharmaceutical characteristics. National competent authorities (NCA) now require a high level of proof to approve such preparations. To evaluate (i) safety of use and (ii) potential efficiency of EM, in vitro characterisation of tissular bioavailability can be performed on devices called diffusion cells.
Purpose Available diffusion cells are research devices that are not well adapted to the context of HP. We developed and validated a new, easy to use, inexpensive and versatile diffusion cell called VitroPharma, meant to obtain permeation and penetration data across a wild range of biological or artificial membranes.
Material and methods VitroPharma was developed in collaboration with a local plasturgist. A validation study using caffeine and testosterone as model compounds, covering (i) infinite and finite donor conditions, (ii) artificial and biological membranes and (iii) different types of liquid and semi-solid receptor fluids was performed. VitroPharma was compared with a widely used diffusion cell reference (ie, Franz cell).
Results Permeation results in both cells were fitted to a mathematical model following Fick’s laws of diffusion. Permeability characteristics given by the model were compared using a non-parametric test. VitroPharma was found to be equivalent to the Franz cell under harmonised experimental conditions. Furthermore, VitroPharma enabled the determination of tissular penetration kinetics which in return enabled prefiguration of EM medicine active ingredient exposure and safety profile in future clinical trials. Such data will be presented to the NCA in the EM pharmaceutical dossier to apply for approval.
Conclusion VitroPharma was adapted to EM development. Furthermore, it can be used in quality control hospital preparations containing BSC class III and IV compounds and in other assessments where penetration and permeation data in a biological or artificial (ie, gloves, conditioning device) membrane are required in hospital pharmacies.
No conflict of interest
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