Abstract

The present study aims to develop an optimized niosome formulation for encapsulation of melatonin using a ball milling (BM) method. Niosomes with and without melatonin inclusions were prepared using a mixture of Span 60 and cholesterol in various molar ratios (2:1, 1:1, and 1:2). The physical properties and stability of the blank niosomes and melatonin-loaded niosomes were characterized using FTIR, TEM, and dynamic light scattering techniques. The results revealed that the BM method was successfully applied to niosome preparation. It provided a smaller average size and a narrower size distribution, with high stability. All niosomal formulations resulted in spherical particles, ranging from 250 nm to 600 nm in diameter with lower polydispersity index values. The niosomes with 1:1 ratios of Span 60 and cholesterol were found to have high stability, suitable for further in vitro drug release study. The entrapment efficiency of melatonin in niosomes was found to range from 85.09% to 86.69%. The results of an in vitro study revealed that the released profile of melatonin-loaded niosomes was more prolonged, with a maximum release of 21% after 48 h. The mechanism of drug release from the niosomes was best described by Higuchi’s model, which indicates that the drug diffuses at a slower rate as the diffusion distance increases. Based on this study, the BM technique is a promising method for the preparation of niosomes for encapsulation of poorly soluble drugs with improved drug release profiles.

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