Franz cells have been used for many years for in vitro release testing (IVRT) to measure the release of a drug from a topical formulation. Whilst they may appear simple they require excellent experimental technique and manual sampling. Chillcot et al. showed a 30% variation across 13 labs doing the same IVRT protocol.
MedPharm has now automated the sampling of the diffusion cells which creates a number of major benefits for clients:
- Reduced variation means that clients can be more confident about any decision made based on the data. This is crucial when optimising formulations or demonstrating the bioequivalence of a new generic formulation compared to the originator product.
- With a bank of 24 cells MedPharm can create more data faster so clients can make decisions earlier in the development process.
- The automated system does not sleep and produces data 24/7 so the datasets are more complete and any trends more defined.
The MedPharm team had to overcome a number of challenges to ensure consistent data. The automation is carefully engineered to avoid an air bubble build-up and the samples are discharged into 96 wells plates so they can be robotically worked up for analysis.
These data from automated cells are currently being used in regulatory submissions.