Abstract
Objective: The goal of the present study was to develop niosomal gel as a nanocarrier for improved depigmentation effect of hydroquinone (HQ). As well as to evaluate the prepared niosomes for entrapment efficiency, transmission electron microscopy (TEM), zeta potential, and in vitro release study. As an ultimate point of the objectives was to evaluate the best-prepared niosomal gel formula clinically in well-diagnosed patients of melasma and the results were compared with a commercial product.
 Methods: The effect of incorporation of co-surfactant such as Tween 20, Tween 40, and Tween 60 with Span 80, was studied to determine the highest entrapment efficiency and the desired release rate. Niosomes showed the highest entrapment efficiency was incorporated in different gelling agents like Carbopol 934 and Carboxymethylcellulose sodium (CMC Na) with different concentrations. Accelerated stability testing of HQ from niosomal gel formulations; the expiry date t90 was estimated. The best-prepared niosomal gel formula was studied clinically in patients of melasma and the results were compared with the commercial product (Clearique 2%)®Delta Pharma Company. 
 Results: There was a significant increase in the clinical efficacy of the niosomal therapy and a highly significant decrease regarding to modified melasma area and severity index (MASI), duration to achieve improvement, side effects, and the recurrence of melasma in patients treated with niosomal gel compared to the commercial product.
 Conclusion: The incorporation of hydroquinone in niosomal gel improves its therapeutic effect regarding clinical effect, duration of treatment, side effects, recurrence and patient compliance.
Highlights
Melasma is an acquired hyperpigmentary disorder on sunlight exposed skin of the face and neck, reported mainly among females with IV or V skin types
Niosomes are microscopic unilamellar or multilamellar spheroid structures formed upon combining non-ionic surfactants with hydrated mixtures of cholesterol (Chol)
All HQ-entrapped niosomes were prepared from a mixture of nonionic surfactant, Chol and co-surfactant
Summary
All HQ-entrapped niosomes were prepared from a mixture of nonionic surfactant, Chol and co-surfactant (table 1). A white suspension was obtained and 1 ml of this suspension was taken with a micro-pipette and transferred to a test tube To this 5 ml methanol was added, which resulted in a clear solution; this was further vortexed in a vortex mixer for 2 min, such that to ensure that the niosomes are lysed completely to release the drug. After separation of the free drug, an accurately measured amount of HQ niosomal formulations, equivalent to 2 mg of HQ was resuspended in 1 ml PBS (pH 7.4) and transferred to the diffusion cell to which a cellulose membrane of the molecular weight cut off 10,000 was attached to one side, and immersed in a receptor compartment containing 100 ml PBS (pH 7.4). The plain drug gel was prepared in the same method, but instead of incorporation of niosome, the plain drug would be incorporated to the best gel base concentration regarding physical properties, in vitro drug release and patient compliance for comparison with niosomal gel
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