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Mucoadhesion and rheology characterization in topical semisolid formulations: An AQbD-driven case study
Lucas Chiarentin1, Vera Moura2, Carla Vitorino3
1Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Laboratórios Basi Indústria Farmacêutica S.A., Parque Industrial Manuel Lourenço Ferreira, lote 15, 3450-232 Mortágua, Portugal; Basinnov Life Sciences, Unipessoal LDA, Avenida José Malhoa, Ed. Malhoa Plaza, n° 2, 3° piso, escritório 3.7, 1070-325 Lisboa, Portugal; Coimbra Chemistry Centre, Institute of Molecular Sciences - IMS, Department of Chemistry, University of Coimbra 3000-535 Coimbra, Portugal.
Abstract:
This study outlines a framework for developing a texture analyzer-based mucoadhesion method integrated with rheology analysis for evaluating ointment formulations. Using an Analytical Quality by Design (AQbD) approach, key sources of variability affecting critical method variables (CMVs) were identified. A Box-Behnken design evaluated applied force, contact time, and trigger force, with optimal conditions selected via response surface methodology (RSM) within the method operable design region (MODR). The final conditions-2 N applied force, 60 s contact time, and 0.05 N trigger force-ensured compliance with the analytical target profile (ATP). Incorporating mucin dispersion revealed significant rheological synergism, validating the optimized method. The framework adheres to ICH guidelines, demonstrating robust and reproducible performance.
