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<p>Self-nanoemulsifying drug delivery system, an isotropic mixture having nanosized globules, is comprised of oils, surfactants, and co-surfactants. The objective of the present work is to fabricate and optimize SNEDDS (liquid and solid form) of BCS class IV drug (Chlorthalidone) via Box-Behnken design utilizing response surface methodology and desirable functionality approach for improving the dissolution profile of the drug. A pseudoternary phase diagram was developed for selecting the concentration ranges (%v/v) of oleic acid (oil), Tween 20-PEG 200 (surfactant and co-surfactant respectively), and water to develop an experimental design layout. The Chlorthalidone-loaded liquid self-nanoemulsifying drug delivery system was optimized via polynomial quadratic equations on each dependent variable (droplet size, self-emulsification time and cumulative percentage drug release at 1&#xa0;h) and characterized on the basis of physicochemical parameters, thermal, and stability studies. Further, to enhance the stability and patient compliance, the powdered form of the optimized formulation was compressed into a tablet and again evaluated. The optimized CTD-loaded&#xa0;SNEDDS,&#xa0;comprising oleic acid (31.46%v/v), Tween 20 (49.12%v/v), and PEG 200 (15.67%v/v), demonstrated nano-ranged droplet size (91.12&#xa0;nm ± 2.01), minimum self-emulsification time (39&#xa0;s ± 1.01), and 85.20% ± 0.08 of CTD release (at 1&#xa0;h) following Higuchi kinetics. The percentage bias lies within the range of − 2.80 to + 3.42%, and the formulation was found to be stable. Moreover, the in vitro drug release of both liquid and solid forms of self-nanoemulsifying drug delivery system was found to be 3.9–four&#xa0;fold increased than pure drug suspension suggesting the formulations as potential candidates for further in vivo study.</p> Graphical Abstract <p></p>

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DoE-based Chlorthalidone Self-nanoemulsifying System: An Approach to Enhance In Vitro Dissolution Profile of BCS Class IV Drug

  • 期刊论文

  • 发表日期：

    2025年7月14日

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  • Ayon Dutta,
  • Swarupananda Mukherjee,
  • Biswajit Basu,
  • Durgesh Ranjan Kar,
  • Bhupendra Prajapati

摘要

Self-nanoemulsifying drug delivery system, an isotropic mixture having nanosized globules, is comprised of oils, surfactants, and co-surfactants. The objective of the present work is to fabricate and optimize SNEDDS (liquid and solid form) of BCS class IV drug (Chlorthalidone) via Box-Behnken design utilizing response surface methodology and desirable functionality approach for improving the dissolution profile of the drug. A pseudoternary phase diagram was developed for selecting the concentration ranges (%v/v) of oleic acid (oil), Tween 20-PEG 200 (surfactant and co-surfactant respectively), and water to develop an experimental design layout. The Chlorthalidone-loaded liquid self-nanoemulsifying drug delivery system was optimized via polynomial quadratic equations on each dependent variable (droplet size, self-emulsification time and cumulative percentage drug release at 1 h) and characterized on the basis of physicochemical parameters, thermal, and stability studies. Further, to enhance the stability and patient compliance, the powdered form of the optimized formulation was compressed into a tablet and again evaluated. The optimized CTD-loaded SNEDDS, comprising oleic acid (31.46%v/v), Tween 20 (49.12%v/v), and PEG 200 (15.67%v/v), demonstrated nano-ranged droplet size (91.12 nm ± 2.01), minimum self-emulsification time (39 s ± 1.01), and 85.20% ± 0.08 of CTD release (at 1 h) following Higuchi kinetics. The percentage bias lies within the range of − 2.80 to + 3.42%, and the formulation was found to be stable. Moreover, the in vitro drug release of both liquid and solid forms of self-nanoemulsifying drug delivery system was found to be 3.9–four fold increased than pure drug suspension suggesting the formulations as potential candidates for further in vivo study.

Graphical Abstract