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<p>The objective of this study was to develop and investigate a Tolfenamic acid (TOL) and Limonin (LIM) co-loaded nanostructured lipid carrier (NLC) based topical gel as a new combinatorial approach to enhance permeation in epidermis and dermis layers of the skin. The solvent emulsification diffusion method was used to develop the NLC using Geleol<sup>®</sup>, Lemon grass oil, and a mixture of Cremophor<sup>®</sup> RH40 and PEG-400 as solid lipid, liquid lipid, surfactant and co-surfactant, respectively. The central composite rotatable design (CCRD) optimized their combination. The optimized TOL-LIM NLC was observed with a particle size of 159.4 ± 1.24&#xa0;nm, polydispersity index of 0.291 ± 0.005, zeta potential of − 15.52 ± 0.74 mV, and entrapment efficiency of &gt; 80% for both drugs. TEM verified the smooth and spherical shape of NLC. FTIR analysis showed that there were no interactions between the drugs and the excipients. In comparison to the conventional gel, the in vitro release studies showed a markedly improved, prolonged, and controlled release of the drugs from the NLC gel. Furthermore, the developed formulation demonstrated antioxidant activity comparable to that of the conventional gel. In vitro and ex vivo permeation studies showed close correlation. When comparing skin treated with the NLC gel to that treated with the conventional gel, dermatokinetic studies showed a significant (<i>p</i> &lt; 0.05) increase in C<sub>Skin max</sub> and AUC<sub>0− 8&#xa0;h</sub>. These results came to the conclusion that the NLC gel is a potential approach for the topical delivery of TOL and LIM.</p>

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Rational Design of CCRD-Optimized Nanostructured Lipid Carrier Co-Encapsulating Tolfenamic acid and Limonin for Improved Topical Therapeutics in Osteoarthritis

  • 期刊论文

  • 发表日期：

    2026年5月30日

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  • Mahak Singh Kasana,
  • Shivani Tyagi,
  • Abhishek Gupta

摘要

The objective of this study was to develop and investigate a Tolfenamic acid (TOL) and Limonin (LIM) co-loaded nanostructured lipid carrier (NLC) based topical gel as a new combinatorial approach to enhance permeation in epidermis and dermis layers of the skin. The solvent emulsification diffusion method was used to develop the NLC using Geleol®, Lemon grass oil, and a mixture of Cremophor® RH40 and PEG-400 as solid lipid, liquid lipid, surfactant and co-surfactant, respectively. The central composite rotatable design (CCRD) optimized their combination. The optimized TOL-LIM NLC was observed with a particle size of 159.4 ± 1.24 nm, polydispersity index of 0.291 ± 0.005, zeta potential of − 15.52 ± 0.74 mV, and entrapment efficiency of > 80% for both drugs. TEM verified the smooth and spherical shape of NLC. FTIR analysis showed that there were no interactions between the drugs and the excipients. In comparison to the conventional gel, the in vitro release studies showed a markedly improved, prolonged, and controlled release of the drugs from the NLC gel. Furthermore, the developed formulation demonstrated antioxidant activity comparable to that of the conventional gel. In vitro and ex vivo permeation studies showed close correlation. When comparing skin treated with the NLC gel to that treated with the conventional gel, dermatokinetic studies showed a significant (p < 0.05) increase in CSkin max and AUC0− 8 h. These results came to the conclusion that the NLC gel is a potential approach for the topical delivery of TOL and LIM.