TY - JOUR TI - Risperidone-Loaded Nasal Thermosensitive Polymeric Micelles: Quality by Design-Based Formulation Study ID - publicatio34438 A1 - Sipos Bence A1 - Katona Gábor A1 - Pannonhalminé Csóka Ildikó SN - 1999-4923 EP - 17 UR - https://doi.org/10.3390/pharmaceutics16060703 N2 - The current research aims to develop thermosensitive polymeric micelles loaded with risperidone for nasal administration, emphasizing the added benefits of their thermosensitive behavior under nasal conditions. An initial risk assessment facilitated the advanced development process, confirming that the key indicators of thermosensitivity were suitable for nasal application. The polymeric micelles exhibited an average size of 118.4 ą 3.1 nm at ambient temperature and a size of 20.47 ą 1.2 nm at 36.5 °C, in both cases in monodisperse distribution. Factors such as pH and viscosity did not significantly impact these parameters, demonstrating appropriate nasal applicability. The model formulations showed a rapid, burst-like drug release profile in vitro, accompanied by a quick and high permeation rate at nasal conditions. Overall, the Quality by Design-based risk assessment process led to the development of an advanced drug delivery system capable of administering risperidone through the nasal cavity. AV - public JF - PHARMACEUTICS VL - 16 IS - 6 Y1 - 2024/// ER -