Self-Nanoemulsifying Isotretinoin Topical Formulation: Development, Optimization and Characterization, in vitro Permeation Study by Using Response Surface Methodology
Sandeep Ghangas1, Praveen Kumar Ashok2, Tanuj Hooda3★★ Corresponding author
- 1Department of Pharmaceutical Sciences, DOPS, VMSB Uttarakhand Technical University, Dehradun, Uttarakhand, INDIA.
- 2Department of Pharmaceutical Sciences, Gyani Inder Singh Institute of Professional Studies, Dehradun, Uttarakhand, INDIA.
- 3Department of Pharmaceutical Sciences, Geeta Institute of Pharmacy, Geeta University, Naultha, Panipat, Haryana, INDIA.
CORRESPONDENCE
Tanuj Hooda
Department of Pharmaceutical Sciences, Geeta Institute of Pharmacy, Geeta University, Naultha, Panipat, Haryana, INDIA.
Received: 04-07-2023; Revised: 17-09-2023; Accepted: 13-10-2023.
Volume 58, Issue 1 · pp. 122–130 · PUBLISHED 2024 · DOI: 10.5530/ijper.58.1.12
ABSTRACT
Aim/Background: The objective of this research was to develop a nano-emulsified formulation by using a central composite design for topical drug delivery. Materials and Methods: Isotretinoin-loaded nano-emulsified drug delivery system was prepared for topical application. Surface response methodology was used for the Design Of Experiment (DOE) using Central Composite Design (CCD). A combination of roseship and soyabean oil was used as the oil phase for the development of the formulation. Kolliphor® EL and Transcutol® P were used as surfactant and co-surfactant, respectively. The impact of independent parameters, percentage of oil phase (X1), and surfactant to co-surfactant ratio (X2) were checked at three levels of dependent variablesviz particle size and drug permeation. Results: p-value in ANOVA tables indicate a significant impact of both independent parameters on dependent parameters. R-sq and R-sq(adj) in both regressions is above 99%, confirming the model's suitability. The final formulation contains 22.07% of the oil phase. The ratio of surfactant and co-surfactant is 40:60. It helped to achieve a minimum particle size of ~280 nm and a maximum percentage permeation of ~ 70%. The optimized formulation was characterized for particle size, zeta potential, refractive index, polydispersity index, thermodynamic stability, and percentage drug permeation. Conclusion: The optimum percentage of the oil phase and surfactant to co-surfactant ratio improved the drug permeation when compared with the marketed formulation.
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Ghangas, S., Ashok, P. K., & Hooda, T. (2024). Self-Nanoemulsifying Isotretinoin Topical Formulation: Development, Optimization and Characterization, in vitro Permeation Study by Using Response Surface Methodology. Indian Journal of Pharmaceutical Education and Research, 58(1), 122–130. https://doi.org/10.5530/ijper.58.1.12
