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Adv Pharm Bull. 2021;11(1): 104-110.
doi: 10.34172/apb.2021.011
  Abstract View: 129
  PDF Download: 37

Research Article

Preparation and Safety Evaluation of Topical Simvastatin Loaded NLCs for Vitiligo

Sahar Yazdani Ashtiani 1 ORCID logo, Saman Ahmad Nasrollahi 1* ORCID logo, Atefeh Naeimifar 2 ORCID logo, Aubid Nassiri Kashani 1, Aniseh Samadi 1 ORCID logo, Somayeh Yadangi 1, Ehsan Aboutaleb 3, Poorya Abdolmaleki 1, Rassoul Dinarvand 2 ORCID logo, Alireza Firooz 1 ORCID logo

1 Pharmaceutical, Cosmeceutical and Hygienic Formulation Lab, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
2 Department of Pharmaceutics, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
3 Department of Pharmaceutics, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.

Abstract

Purpose: Vitiligo is a long-term common autoimmune disease in which growing patches of skin lose their color. There is no FDA-approved treatment for vitiligo. However, recent studies have demonstrated an immunosuppressive effect on vitiligo lesions in mouse models by simvastatin. A topical formulation was prepared containing simvastatin-loaded nano lipid carriers (simNLCs) for vitiligo treatment followed by evaluating their physicochemical characteristics and clinical safety.

Methods: Both the lipid phase and the aqueous phase were heated to 75°C separately, and then simvastatin was dispersed in the lipid phase added to the aqueous phase. The mixture was homogenized for 1 minute, then for Nanostructured Lipid Carriers (NLC) formation, the emulsion was sonicated using a probe sonicator. The simNLCs produced were evaluated for drug entrapment, particle size and morphology, zeta potential, polydispersity index, viscosity, drug content, in vitro drug release, in vivo skin safety test, and long-term stability studies.

Results: Dynamic light scattering, transmission electron microscopy and differential scanning calorimetry techniques proved the formation of a stable formulation containing spherical particles with nanoscale size. The drug entrapment efficiency and the drug-loading capacity were determined to be 99.27% and 3.9%, respectively. Human safety results indicated that adding simvastatin to lipid nanoparticles did not cause any changes to skin biophysical parameters.

Conclusion: The preparation method of simNLC developed in this study is a suitable method, and the nanoparticles fabricated were safe with acceptable long-term stability and drug entrapment.

Keywords: Nano lipid carriers, Probe sonication, Simvastatin, Safety, Vitiligo
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Submitted: 30 Jun 2019
Revision: 24 Feb 2020
Accepted: 19 Apr 2020
ePublished: 07 Nov 2020
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