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<p>Diabetic neuropathy, a common complication of diabetes, significantly impairs the quality of life due to sensory loss and chronic pain. Duloxetine HCl (DXH), a serotonin-norepinephrine reuptake inhibitor, is widely used for managing neuropathic pain but is limited by low oral bioavailability and systemic side effects. This study explores the potential of a transferosome-based transdermal gel system for DXH delivery, aiming to enhance bioavailability, reduce first-pass metabolism, and achieve sustained drug release. DXH-loaded transferosomes (DXH-TFs) were formulated using the thin-film hydration method and optimized through a Box–Behnken design. The optimized DXH-TFs demonstrated a nanoscale particle size (84.58&#xa0;nm), high drug entrapment efficiency (81.65%), and superior transdermal flux (42.63&#xa0;μg/cm<sup>2</sup>/h). Characterization studies confirmed drug encapsulation and stability, while in vitro and ex vivo assessments revealed sustained drug release over 24&#xa0;h. In vivo pharmacodynamic studies in streptozotocin-induced diabetic neuropathy models highlighted significant reductions in heat hyperalgesia and cold allodynia, with DXH-TF gel providing comparable efficacy to oral DXH while minimizing systemic exposure. Stability studies confirmed the robustness of the formulation under accelerated conditions. The findings underscore the potential of transferosomal gel systems as an innovative and effective approach for the transdermal delivery of DXH in diabetic neuropathy management.</p>

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Transferosome-Enhanced Transdermal Therapy: A Novel Approach for Duloxetine Delivery for Management of Neuropathic Pain

  • 期刊论文

  • 发表日期：

    2025年3月17日

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  • Pramod S. Salve,
  • Mohammad Qutub,
  • Ujban Md Hussain Hussain,
  • Amol A. Tatode,
  • Samiksha Tammewar

摘要

Diabetic neuropathy, a common complication of diabetes, significantly impairs the quality of life due to sensory loss and chronic pain. Duloxetine HCl (DXH), a serotonin-norepinephrine reuptake inhibitor, is widely used for managing neuropathic pain but is limited by low oral bioavailability and systemic side effects. This study explores the potential of a transferosome-based transdermal gel system for DXH delivery, aiming to enhance bioavailability, reduce first-pass metabolism, and achieve sustained drug release. DXH-loaded transferosomes (DXH-TFs) were formulated using the thin-film hydration method and optimized through a Box–Behnken design. The optimized DXH-TFs demonstrated a nanoscale particle size (84.58 nm), high drug entrapment efficiency (81.65%), and superior transdermal flux (42.63 μg/cm2/h). Characterization studies confirmed drug encapsulation and stability, while in vitro and ex vivo assessments revealed sustained drug release over 24 h. In vivo pharmacodynamic studies in streptozotocin-induced diabetic neuropathy models highlighted significant reductions in heat hyperalgesia and cold allodynia, with DXH-TF gel providing comparable efficacy to oral DXH while minimizing systemic exposure. Stability studies confirmed the robustness of the formulation under accelerated conditions. The findings underscore the potential of transferosomal gel systems as an innovative and effective approach for the transdermal delivery of DXH in diabetic neuropathy management.