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Purpose <p>Purpose of the study is to develop, optimize and evaluate a nanostructured lipid carrier (NLC) formulation containing 4-Octyl itaconate for the treatment of atopic dermatitis (AD).</p> Methods <p>NLCs were formulated and optimized using the Box-Behnken design. The optimized NLCs underwent comprehensive characterization, including morphological analysis, stability studies, and drug release profiling. The nanostructured lipid carriers (NLCs) were subsequently incorporated into a topical hydrogel formulation. Preclinical efficacy was evaluated using a DNCB-induced atopic dermatitis model in BALB/c mice, with therapeutic outcomes compared to standard treatments through biochemical assays and ELISA. Additionally, western blotting was performed to analyze the expression of TSLP and FLG, providing insight into the formulation’s effect on disease pathophysiology.</p> Results <p>NLC formulation exhibited a particle size within the desired range (Nanosized), a low polydispersity index, zeta potential, and high entrapment efficiency. Stability studies confirmed the formulation’s robustness, while drug release profiles indicated sustained release. In vivo studies revealed that 4-OI-NLC-G effectively reduced dorsal skin thickness, epidermal thickness, and trans-epidermal water loss in DNCB-treated mice. It also alleviated dermatitis severity by lowering the skin score, suppressing serum IgE levels, and inhibiting TNF-α expression in skin tissue. Additionally, 4-OI-NLC-G enhanced FLG expression while mitigating TSLP-induced inflammation, promoting epidermal restoration.</p> Conclusion <p>This study highlights the successful development of an optimized NLC formulation for effective topical delivery of 4-Octyl itaconate in atopic dermatitis treatment. The formulation exhibited enhanced therapeutic outcomes in a preclinical AD model, demonstrating its potential for clinical translation. The results emphasize the importance of rational design and optimization in developing advanced drug delivery systems for inflammatory skin diseases.</p>

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Quality by design based hydrogel formulation of 4-Octyl itaconate-loaded nanostructured lipid carriers for epidermal restoration in atopic dermatitis

  • 期刊论文

  • 发表日期：

    2025年6月25日

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  • Manaswini Behera,
  • Priyanka Mahale,
  • A. Gowtham,
  • Ashish Dilip Sutar,
  • Ravinder K. Kaundal,
  • Rahul Shukla

摘要

Purpose

Purpose of the study is to develop, optimize and evaluate a nanostructured lipid carrier (NLC) formulation containing 4-Octyl itaconate for the treatment of atopic dermatitis (AD).

Methods

NLCs were formulated and optimized using the Box-Behnken design. The optimized NLCs underwent comprehensive characterization, including morphological analysis, stability studies, and drug release profiling. The nanostructured lipid carriers (NLCs) were subsequently incorporated into a topical hydrogel formulation. Preclinical efficacy was evaluated using a DNCB-induced atopic dermatitis model in BALB/c mice, with therapeutic outcomes compared to standard treatments through biochemical assays and ELISA. Additionally, western blotting was performed to analyze the expression of TSLP and FLG, providing insight into the formulation’s effect on disease pathophysiology.

Results

NLC formulation exhibited a particle size within the desired range (Nanosized), a low polydispersity index, zeta potential, and high entrapment efficiency. Stability studies confirmed the formulation’s robustness, while drug release profiles indicated sustained release. In vivo studies revealed that 4-OI-NLC-G effectively reduced dorsal skin thickness, epidermal thickness, and trans-epidermal water loss in DNCB-treated mice. It also alleviated dermatitis severity by lowering the skin score, suppressing serum IgE levels, and inhibiting TNF-α expression in skin tissue. Additionally, 4-OI-NLC-G enhanced FLG expression while mitigating TSLP-induced inflammation, promoting epidermal restoration.

Conclusion

This study highlights the successful development of an optimized NLC formulation for effective topical delivery of 4-Octyl itaconate in atopic dermatitis treatment. The formulation exhibited enhanced therapeutic outcomes in a preclinical AD model, demonstrating its potential for clinical translation. The results emphasize the importance of rational design and optimization in developing advanced drug delivery systems for inflammatory skin diseases.