Development and Optimization of Eberconazole Nanostructured Lipid Carrier Topical Formulations Based on the QbD Approach

Jul 15, 2026

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Eberconazole nanostructured lipid carrier (EBR-NLC) 1% w/w topical formulations were optimized using a Quality by Design (QbD) workflow. A 2^3 full factorial design evaluated effects of total lipid amount, surfactant amount, and sonication time on particle size and entrapment efficiency. The optimized formulation was characterized for assay, impurities, rheology, validated in-vitro release testing (vertical diffusion cells), ex-vivo permeation, and skin retention. Compared with EBERNET® cream, higher release, permeation, and retention were observed (P<0.05), with stability for at least six months under specified conditions.

LanguageEnglish

CategoryResearch & Report

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Pages17

Reading Time43 min

AAPS PharmSciTech (2025) 26:87 [https://doi.org/10.1208/s12249-025-03083-x](https://doi.org/10.1208/s12249-025-03083-x) Development and Optimization of Eberconazole Nanostructured Lipid Carrier Topical Formulations Based on the QbD Approach Amarnath Reddy Ramireddy1 · Dilip Kumar Behara2 Received: 28 December 2024 / Accepted: 1 March 2025 / Published online: 18 March 2025 © The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists 2025 Abstract Eberconazole nanostructured lipid carrier (EBR-NLC) 1% w/w optimization was done using the Quality by Design (QbD) approach, employing a 23 Full Factorial Design (FFD) for experimental planning, followed by thorough physico-chemical, in-vitro, and ex-vivo evaluations. The 23 FFD assessed the impact of total lipid amount, surfactant amount, and sonication time on critical quality attributes such as particle size and % entrapment efficiency. In-vitrorelease testing (IVRT) validation was performed using vertical diffusion cells. IVRT, a compendial technique by pharmacopoeias, was for performing semisolid formulations analysis. The optimized EBR-NLC 1% w/w was characterized for assay, organic impurities, amplitude sweep, viscosity, IVRT, ex-vivo permeation testing, and skin retention. The validated IVRT technique was meeting the acceptance criteria of regulatory guidelines. The results showed that in-vitro release, ex-vivo permeation, and skin retention were significantly higher (P< 0.05) for the optimized EBR-NLC 1% w/w formulation compared to the innovator formulation (EBERNET® Cream 1% w/w) . Applying QbD principles systematically facilitated the successful development and optimization of an EBR-NLC 1% w/w. The optimized EBR-NLC 1% w/w formulation proved to be a viable alternative, showing stability for at least six months under conditions of 40°C/75% RH and 30°C/75% RH. Keywords Eberconazole · Ex-vivo permeation testing · Full factorial design · In-vitro release testing · Nanostructured lipid carrier · Quality by Design Summary • Eberconazole nanostructured lipid carrier 1% w/w was formulated and optimized by Quality by Design QbD. • In-vitro release testing (IVRT), a compendial technique, was developed and validated for estimation of Eberconazole release. • Ex-vivo permeation testing and skin retention were performed for nanostructured lipid carrier. • IVRT was used for the performance analysis of nanostructured lipid carrier 1% w/w. * Amarnath Reddy Ramireddy [amarpharmacy123@gmail.com](amarpharmacy123@gmail.com) Dilip Kumar Behara [dileepbh.chemengg@jntua.ac.in](dileepbh.chemengg@jntua.ac.in) 1 Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University Anantapur (JNTUA), Anantapuramu, Andhra Pradesh, India 515002 2 JNTUA College of Engineering (Autonomous), Jawaharlal Nehru Technological University Anantapur (JNTUA), Anantapuramu, Andhra Pradesh, India 515002 Introduction Fungal skin infections are a signific

Jul 15, 2026

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