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Submitted: 24 Jan 2024
Revision: 02 Aug 2024
Accepted: 08 Sep 2024
ePublished: 15 Sep 2024
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Adv Pharm Bull. 2024;14(4): 858-869.
doi: 10.34172/apb.42731
  Abstract View: 207
  PDF Download: 54

Research Article

Green Formulation of Menadione-Loaded Niosome as a Skin-Lightening Preparation: In Vitro/In Vivo Safety Evaluation on Wistar Rat

Majid Saeedi 1,2 ORCID logo, Katayoun Morteza-Semnani 3, Jafar Akbari 1, Seyyed Mobin Rahimnia 1,2* ORCID logo, Fatemeh Ahmadi 4, Mohammad Reza Mojaveri 4, Saghar Ahmadipour 4, Seyyed Mohammad Hassan Hashemi 5,6* ORCID logo

1 Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
2 Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.
3 Department of Medicinal Chemistry, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
4 Student Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
5 Food Health Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
6 Department of Pharmaceutics, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
*Corresponding Authors: Seyyed Mobin Rahimnia, Email: mobin.rahimnia@yahoo.com; Seyyed Mohammad Hassan Hashemi, Email: smhhashemipharma@gmail.com

Abstract

Purpose: In the present research, a green technique (an ultrasonic method) was used to synthesize menadione sodium bisulfite (MSB) niosome (Menasome) which is used to improve dermal delivery and increase anti-melanogenesis activities.

Methods: Various cholesterol: surfactant (Chol: Sur) ratios were investigated to optimize the Menasomes. Photon correlation spectroscopy, attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR), transmission electron microscopy (TEM), and differential scanning calorimetry (DSC) were employed to characterize the solid state of MSB in nanoparticle form. Additionally, the optimized formulation was used to investigate ex-vivo skin absorption, in vivo skin irritation, in vitro cell survival, and anti-melanogenesis activity.

Results: The results exhibited that increasing cholesterol declined the average size of the Menasomes from 653.766±25.171 nm to 298.133±8.823 nm and increased entrapment efficiency 30.237±3.4204% to 83.616±2.550 %. The rat skin permeation study indicated that Menasome gel administered more MSB in dermal layers (439.000±36.190 μg/cm2 or 23.827±1.964%) than MSB plain gel (286.200±22.6 μg/cm2 or 15.53±1.227%). In both the in vivo skin irritation test and the in vitro cytotoxicity experiment, the extended-release behavior of the enhanced Menasome demonstrated a minimal side effect profile. Furthermore, optimum Menasome inhibited melanin formation (37.426±1.644% at 15μM) greater than free MSB (57.383±1.654%) considerably (P<0.05). Furthermore, Menasome 7 prevented L-dopa auto-oxidation in higher levels (95.140±2.439%) than pure MSB solution (83.953±1.629%).

Conclusion: According to the study’s findings, the prepared Menasome could be employed as a viable nanovehicle for MSB dermal delivery, a promising solution for the management of human hyperpigmentation disorders.


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