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Design of Experiment Navigated Methodical Development of Neem Oil Nanoemulsion Containing Tea Tree Oil for Dual Effect Against Dermal Illness: Ex Vivo Dermatokinetic and In Vivo

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Abstract

This study was designed to develop neem oil nanoemulsion of tea tree oil (TTO-NO-NE) using design of experiment based Box–Behnken design, which provided thermodynamic stable NE with globule size of 174 nm, and PDI 0.28, respectively. Whereas the zeta potential of optimized NE has occurred as − 20 mV with spherical and non-segregated in shape. Next, TTO-NO-NE-loaded nanogel and conventional gel were prepared, and initially, a comparative evaluation was performed for homogeneity, pH, spreadability, extrudability, and drug content. Furthermore, in vitro release pattern, ex vivo dermatokinetic profile, in vivo skin safety study, and stability of nanogel was determined. Comparative in vitro release study showed significantly sustained release of drug from nanogel (p < 0.005) when compared to the conventional gel. Simultaneously, a comparative ex vivo dermatokinetic study demonstrated significantly maximum drug deposition for nanogel (p < 0.05) than conventional gel. Moreover, in vivo skin safety study exhibited no signs of toxicity in terms of zero scoring for nanogel and was considered safe for future use. Finally, a stability study showed no significant (p > 0.05) variation in the pH, spreadability, extrudability, and drug content of optimized nanogel, which claims good stability for nanogel after 6 months of storage in prescribed environmental conditions. Thus, it can be concluded that the developed novel nanogel is a promising therapeutic asset that can mitigate dermal infections effectively.

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Acknowledgements

This project was funded by the Deanship of Scientific Research (DSR) at King Abdulaziz University, Jeddah, under Grant No. (G: 104-140-1442). The authors, therefore, acknowledge with thanks to DSR for technical and financial support.

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Authors and Affiliations

  1. Department of Medical Microbiology and Parasitology, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

    Hani Z. Asfour & Mohammed W. Al-Rabia

  2. Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia

    Nabil A. Alhakamy & Shadab Md

  3. Center of Excellence for Drug Research & Pharmaceutical Industries, King Abdulaziz University, Jeddah, Saudi Arabia

    Nabil A. Alhakamy & Shadab Md

  4. Research & Development, Jamjoom Pharmaceuticals, Jeddah, 21442, Saudi Arabia

    Md Shoaib Alam

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  1. Hani Z. Asfour
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Asfour, H.Z., Alhakamy, N.A., Alam, M.S. et al. Design of Experiment Navigated Methodical Development of Neem Oil Nanoemulsion Containing Tea Tree Oil for Dual Effect Against Dermal Illness: Ex Vivo Dermatokinetic and In Vivo. J Clust Sci 34, 1311–1323 (2023). https://doi.org/10.1007/s10876-022-02301-x

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