Bluepharma is pleased to share its latest article entitled ‘Development of a buccal in vitro permeation method – exploring aQbD implementation’, published in the prestigious International Journal of Pharmaceutics.
In this research paper, a systematic risk-based analytical quality by design (aQbD) approach is applied to the development of a buccal in vitropermeation method. Applying aQbD concepts, all sources of variability affecting permeation are identified, explained and managed by appropriate measures.
This is the first research paper to apply these tools in method development aiming the assessment of buccal permeation (to our knowledge).
Ariana Sena, Alain Costa, Francisca Bastos, Ana Catarina Pinto, Carla Vitorino, António Nunes, Sérgio Simões.
International Journal of Pharmaceutics, 2023
https://doi.org/10.1016/j.ijpharm.2023.123255
Abstract
The buccal mucosa is arising within the pharmaceutical landscape as an attractive option for local and systemic drug delivery, mostly due to its high vascularization, inherent permeability and robustness. Still, one of the major challenges in bringing oromucosal preparations to market remains the accurate evaluation of permeability. During pre-clinical drug development, in vitro permeation assessment is essential, and methodologies, based on the selection of a proper membrane in a diffusion cell, have become appealing alternatives to the conventional cell-based models. The development of such methods is being constrained by the number of variables - related to study conditions, setup and formulation - that need to be optimized to accurately estimate buccal permeation. The gap of knowledge over the mentioned variables may lead to long costly developments and poorly accurate methods, especially if the empirical analytical approach is used.
In this paper, a systematic risk-based analytical quality by design approach was applied to the development of a buccal in vitro permeation method, ensuring that all sources of variability affecting permeation process were identified, explained and managed by appropriate measures. Researchers are guided through a step by step model, successfully demonstrating with experimental data the impact of critical variables on method’s performance.