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These results demonstrated the efficacy of statistical experimental design to unveil the critical formulation interactions and variability affecting the performance of proniosomal formulations.
Overall, applying quality by design paradigm to the development of tenofovir niosomal gels not only offered a promising nanomedicine for the vaginal microbicide delivery but also unveiled the critical formulation interactions influencing its biological performance.
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In fact, the importance of the individual bioequivalence concept is recently being claimed, which would allow the scaling of the established intervals based on the individual comparison and the subject – formulation interaction [ 17, 18].
This work shows how sex-by-formulation interaction can affect bioequivalence conclusions.
Moreover, the formulations' interaction with skin was analysed by ATR-FTIR.
Over this parameter, a significant sex-by-formulation interaction was detected: 90CI CMAX T/R was 0.838 1.36 in women and 0.540 0.920 in men; with a 52% relative difference between point estimates.
The second problem is what is called subject-by-formulation interaction.
The interaction coating thickness – coating formulation, the interaction between the fluid bed temperature and the coating formulation and the coating formulation as well as the interaction costing thickness – fluid bed temperature were found to be very significant.
A head-to-head comparison of 'matched' SX and SS formulations when aerosolised from the same three devices demonstrated that formulation-device interactions are as critical in determining the in vitro deposition of drug-lactose blends as the identity of the active pharmaceutical ingredient.
Confocal microscopy images and association tests provided an insight into the contribution of formulation-cell interactions vs. the contribution of DOX release rate.
It is evident that when different liquids and different types of polymer molecules are introduced in the gel formulations, multiple interactions may develop among the components whose effects are not easy to predict.
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CEO of Professional Science Editing for Scientists @ prosciediting.com