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<p>The present study was undertaken to develop and evaluate matrix-type transdermal patches of flufenamic acid and tenoxicam for controlled drug delivery. Both drugs are nonsteroidal anti-inflammatory agents (NSAIDs) that, when administered orally, are commonly associated with gastrointestinal side effects and extensive first-pass metabolism. To overcome these limitations, transdermal patches were formulated using the solvent casting technique with varying concentrations of hydroxypropyl methylcellulose (HPMC), Eudragit RS 100 (ERS 100), and glycerol. A full 2³ factorial design was employed to investigate the influence of these formulation variables on drug release behavior. The prepared patches were evaluated for physicochemical and mechanical properties, including thickness, weight variation, drug content uniformity, moisture content, moisture uptake, swelling index, folding endurance, and tensile strength. In vitro drug release studies were performed using Franz diffusion cells. The results demonstrated that all formulations exhibited uniform physicochemical characteristics and provided sustained drug release for up to 24&#xa0;h. Among the developed formulations, the DoE-optimized formulation (F4) showed optimal drug release along with satisfactory mechanical strength and stability. Statistical analysis using ANOVA revealed that HPMC exerted a negative effect on drug release, whereas glycerol showed a statistically significant positive influence (<i>p</i> &lt; 0.01). Drug release followed diffusion-controlled mechanisms, as confirmed by the Korsmeyer–Peppas model, and the release kinetics were best described by zero-order and Higuchi models. Fourier transform infrared (FTIR) spectroscopy confirmed the compatibility between the drugs and the selected polymers. Stability studies conducted for 90 days indicated no significant changes in the physical appearance or drug content of the optimized formulation. Overall, the study successfully demonstrates the potential of customized transdermal patches for the delivery of flufenamic acid and tenoxicam. This delivery approach offers sustained drug release, improved patient compliance, and reduced systemic side effects, making it a promising alternative for the management of chronic pain conditions.</p>

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Controlled Drug Delivery of Tenoxicam and Flufenamic Acid Via Transdermal Patches: A DOE Optimization Study

  • 期刊论文

  • 发表日期：

    2026年5月8日

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  • Payal N. Vaja,
  • Hardik L. Varu,
  • Chetan H. Borkhataria,
  • Chetankumar B. Rathod

摘要

The present study was undertaken to develop and evaluate matrix-type transdermal patches of flufenamic acid and tenoxicam for controlled drug delivery. Both drugs are nonsteroidal anti-inflammatory agents (NSAIDs) that, when administered orally, are commonly associated with gastrointestinal side effects and extensive first-pass metabolism. To overcome these limitations, transdermal patches were formulated using the solvent casting technique with varying concentrations of hydroxypropyl methylcellulose (HPMC), Eudragit RS 100 (ERS 100), and glycerol. A full 2³ factorial design was employed to investigate the influence of these formulation variables on drug release behavior. The prepared patches were evaluated for physicochemical and mechanical properties, including thickness, weight variation, drug content uniformity, moisture content, moisture uptake, swelling index, folding endurance, and tensile strength. In vitro drug release studies were performed using Franz diffusion cells. The results demonstrated that all formulations exhibited uniform physicochemical characteristics and provided sustained drug release for up to 24 h. Among the developed formulations, the DoE-optimized formulation (F4) showed optimal drug release along with satisfactory mechanical strength and stability. Statistical analysis using ANOVA revealed that HPMC exerted a negative effect on drug release, whereas glycerol showed a statistically significant positive influence (p < 0.01). Drug release followed diffusion-controlled mechanisms, as confirmed by the Korsmeyer–Peppas model, and the release kinetics were best described by zero-order and Higuchi models. Fourier transform infrared (FTIR) spectroscopy confirmed the compatibility between the drugs and the selected polymers. Stability studies conducted for 90 days indicated no significant changes in the physical appearance or drug content of the optimized formulation. Overall, the study successfully demonstrates the potential of customized transdermal patches for the delivery of flufenamic acid and tenoxicam. This delivery approach offers sustained drug release, improved patient compliance, and reduced systemic side effects, making it a promising alternative for the management of chronic pain conditions.