The relevance of non-standardised in vitro nasal cast models in product development
Lucas Silva1, Nathalie Hauchard2, Nuria Manzano1 & Gonçalo Farias2
1Nanopharm Ltd, Franklin House, Grange Road, Cwmbran, NP44 3WY, UK
2Aptar Pharma, Route des Falaises, Le Vaudreuil, 27100, France
Summary
More realistic in vitro tools are being explored to facilitate product development by providing a better link between in vitro studies and in vivo outcomes. Standardisation is usually seen as a major challenge for these novel tools.
In this study, the nasal regional deposition of two distinct nasal products (liquid and powder) was evaluated in two different nasal cast models: one sophisticated model validated in vivo (Aeronose™) and one idealised model (AINI). Both nasal casts were able to track differences in regional deposition of two products with comparable results in anterior and posterior deposition. Nonetheless, a different deposition on the olfactory region was observed, possibly related to differences in adhesion of the powder to the nasal cast. Standardisation of realistic in vitro tools might be useful from a quality control perspective particularly by using idealised models. However, it might not be required during product development, where sophisticated and complete geometry models that can be built to be representative of certain target populations could be used as long as those models are validated with in vivo studies.
Key Message
Two distinctly different, validated nasal cast models were able to similarly discriminate differences in the regional deposition of two nasal products. Different nasal cast models could be used during product development studies as long as these have been validated with in vivo studies.