Reducing in vitro method development of long-acting injectables through an image-based dissolution model. Development of long acting injectable (LAI) formulations like in situ gels and nano-suspensions requires lengthy in vitro and in vivo testing that potentially require their own method developments. This challenge can lead to excessive delays in the development pipeline that are both risky in cost and for the potential failure of the therapy in clinical trials. We have developed a robust characterization approach for long acting injectables that allows for rapid in vitro characterization. Rather than focus on chemical testing, our method leverages non-invasive imaging of the LAI depot coupled with dissolution modelling based on the depot geometry and chemistry. This methodology requires no additional method development for in vitro testing as the geometry of the depot is the primary influence on dissolution. This approach can even be coupled with injection of the depot into tissue systems for even more bio-relevant studies. We demonstrate the power of this method for in situ forming depots where our image-based simulation approach performs better than traditional in vitro methods in a fraction of the time.
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