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<p>This study aimed to develop mirtazapine-loaded transferosomes (MRT-TFs) incorporated into a thermosensitive nasal gel (TNG) for targeted brain delivery. MRT-TFs were prepared using the thin film hydration method and optimized through a Box-Behnken design (BBD) with Design-Expert software. Lecithin and Tween®80 were used as the lipid and surfactant. Thermosensitive nasal gel was prepared via the cold method and optimized by a hit-and-trial approach. The MRT-TFs and MRT-TFs-TNG formulations were characterized in vitro, ex vivo, and in vivo. The optimized MRT-TFs formulation exhibited a particle size of 127 ± 0.5&#xa0;nm, a zeta potential of − 23.8 ± 0.09&#xa0;mV, and an encapsulation efficiency of 89 ± 1.1%. Fourier transform infrared spectroscopy analysis showed no chemical interactions, while transmission electron microscopy revealed spherical transferosomes. X-ray diffraction analysis confirmed mirtazapine was in an amorphous form in the TFs. The optimized formulation demonstrated sustained release and enhanced permeation (<i>P</i> &lt; 0.001) compared to the MRT- Suspension. Stability studies confirmed the formulation remained stable at 5&#xa0;°C for 6&#xa0;months. Pharmacokinetic studies showed improved bioavailability and brain-targeting efficiency, confirming the efficacy of the formulation. Toxicity studies confirmed its biocompatibility. In conclusion, the incorporation of Transferosomes into thermosensitive nasal gel offer a promising strategy for non-invasive brain drug delivery, enhancing mirtazapine’s therapeutic potential. </p> Graphical Abstract <p></p>

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Brain Targeting of Mirtazapine Via Transferosome Embedded Thermoresponsive Nasal Gel for Sustained Release and Augmenting Bioavailability

  • 期刊论文

  • 发表日期：

    2025年3月26日

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  • Amjad Ali Shah,
  • Rashna Mirza,
  • Aqeedat Javed

摘要

This study aimed to develop mirtazapine-loaded transferosomes (MRT-TFs) incorporated into a thermosensitive nasal gel (TNG) for targeted brain delivery. MRT-TFs were prepared using the thin film hydration method and optimized through a Box-Behnken design (BBD) with Design-Expert software. Lecithin and Tween®80 were used as the lipid and surfactant. Thermosensitive nasal gel was prepared via the cold method and optimized by a hit-and-trial approach. The MRT-TFs and MRT-TFs-TNG formulations were characterized in vitro, ex vivo, and in vivo. The optimized MRT-TFs formulation exhibited a particle size of 127 ± 0.5 nm, a zeta potential of − 23.8 ± 0.09 mV, and an encapsulation efficiency of 89 ± 1.1%. Fourier transform infrared spectroscopy analysis showed no chemical interactions, while transmission electron microscopy revealed spherical transferosomes. X-ray diffraction analysis confirmed mirtazapine was in an amorphous form in the TFs. The optimized formulation demonstrated sustained release and enhanced permeation (P < 0.001) compared to the MRT- Suspension. Stability studies confirmed the formulation remained stable at 5 °C for 6 months. Pharmacokinetic studies showed improved bioavailability and brain-targeting efficiency, confirming the efficacy of the formulation. Toxicity studies confirmed its biocompatibility. In conclusion, the incorporation of Transferosomes into thermosensitive nasal gel offer a promising strategy for non-invasive brain drug delivery, enhancing mirtazapine’s therapeutic potential.

Graphical Abstract