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Adv Pharm Bull. 2024;14(1): 161-175.
doi: 10.34172/apb.2024.011
  Abstract View: 575
  PDF Download: 417

Research Article

Green Formulation of Spironolactone Loaded Chitosan-Coated Nano Lipid Carrier for Treatment of Acne Vulgaris: A Randomized Double-Blind Clinical Trial

Majid Saeedi 1,2 ORCID logo, Katayoun Morteza-Semnani 3, Jafar Akbari 2, Zohreh Hajheydari 4, Amin Goodarzi 5, Seyyed Sohrab Rostamkalaei 6, Seyyed Mohammad Hassan Hashemi 7* ORCID logo, Seyyed Mobin Rahimnia 2,5* ORCID logo

1 Pharmaceutical Sciences Research Center, Haemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.
2 Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
3 Department of Medicinal Chemistry, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
4 Department of Dermatology, Boo Ali Sina (Avicenna) Hospital, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.
5 Student Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
6 Department of Pharmaceutics, Faculty of Pharmacy, Ayatollah Amoli Branch, Islamic Azad University, Amol, Iran.
7 Department of Pharmaceutics, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
*Corresponding Authors: Seyyed Mohammad Hassan Hashemi, Email: smhhashemipharma@gmail.com; Seyyed Mobin Rahimnia, Email: mobin.rahimnia@yahoo.com

Abstract

Purpose: Spironolactone (SPN), which is classified as an anti-androgen, has demonstrated efficacy in treating acne. This study aimed to utilize ultrasonication to create a chitosan-coated nano lipid carrier (NLC) for enhancing the delivery of SPN to the skin and treating acne.

Methods: Various hydrophilic-lipophilic balance (HLB) values were investigated to optimize the SPN-NLCs. 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 SPN in nanoparticle form. Additionally, the optimized formulation was used in a double-blind, randomized clinical trial.

Results: Reducing the HLB of the surfactant mixtures resulted in a reduction in the size of SPNNLCs. The formula with the smallest particle diameter (238.4±0.74 nm) and the lowest HLB value (9.65) exhibited the highest encapsulation efficiency (EE) of 79.88±1.807%. Coating the optimized SPN-NLC with chitosan increased the diameter, polydispersity index (PDI), zeta potential (ZP), and EE. In vitro skin absorption studies demonstrated sustained release profiles for chitosan-coated SPN-NLC. In the double-blind trial, a gel containing chitosan-coated SPN-NLC effectively treated mild to moderate acne vulgaris, leading to improved healing and reduced lesion count after 8 weeks of therapy compared to the placebo. It successfully addressed both non-inflammatory and inflammatory lesions without adverse effects on the skin.

Conclusion: The findings indicate that chitosan-coated SPN-NLCs have the potential as nanoparticles for targeted SPN delivery to the skin, offering novel options for the treatment of acne vulgaris.

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Submitted: 04 Apr 2023
Revision: 18 Aug 2023
Accepted: 20 Sep 2023
ePublished: 23 Sep 2023
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