Formulation and evaluation of fexofenadine hydrochloride-loaded niosomes for topical delivery
DOI:
https://doi.org/10.12923/cipms-2026-0022Keywords:
fexofenadine hydrochloride, chronic idiopathic urticaria, niosomes, ex vivo permeation, ultra-deformableAbstract
Fexofenadine hydrochloride (FEX HCl), a second-generation antihistamine, is widely used in the treatment of chronic idiopathic urticaria (CIU). The present study aimed to develop and optimize FEX-loaded niosomes to enhance topical drug delivery for the management of CIU. Eight batches of niosomes were prepared using a 2³ full factorial design by the ethanol evaporation method. The percentage entrapment efficiency (%EE) and percentage in vitro drug release at 8 h (%DR) of the model niosomal formulations ranged from 53.67 ± 0.16% to 77.32 ± 0.20% and from 42.80 ± 0.25% to 64.32 ± 0.24%, respectively. The optimized niosomal batch exhibited a reduced particle size of 160 ± 7.3 nm, good colloidal stability, with a zeta potential of −28.9 ± 5.5 mV, and high entrapment efficiency of 77.32 ± 0.20%. Scanning electron microscopy indicated the spherical morphology and nanoscale size of the niosomes, whereas differential scanning calorimetry and X-ray diffractometry confirmed the presence of the drug in a molecular state within the niosomal bilayer. The optimized formulation was incorporated into a Carbopol-based gel and evaluated for physical properties, in vitro drug release, and ex vivo skin permeation. The niosomal gel showed prolonged drug release, with 63.57 ± 2.21% released within 8 h, compared with the drug solution. Ex vivo studies demonstrated significantly enhanced (p < 0.0001) skin permeation, with 51.97 ± 0.28 µg/cm³ drug permeated from the niosomal gel compared with 30.00 ± 0.28 µg/cm³ from the FEX gel. These results indicate that niosomes may be promising carriers for the topical delivery of FEX in the treatment of CIU.
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Copyright (c) 2026 H.S. Lavanya, H.N. Shivakumar , Bindu Banakar, Rushikesh Shinde (Autor)
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