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<p>Management of severe nausea and vomiting in patients undergoing chemotherapy is challenging with traditional drug delivery techniques as emesis itself is a barrier in peroral drug delivery. Moreover, intravenous administration is poorly compliant due to invasiveness, pain and discomfort associated with it. A polymeric microneedle patch (G-FDM) was developed to overcome the drawbacks of conventional drug delivery. The formulation was optimized through 3-level factorial design and comprehensively characterized for transdermal delivery of Granisetron HCl; a vital antiemetic agent. This rigorous optimization process resulted in an ideal formulation (G-FDM<sub>o</sub>) that demonstrated robust mechanical strength, excellent structural and morphological integrity as confirmed through structural and morphological characterization techniques (SEM, FTIR, DSC and XRD). The optimized patch also exhibited excellent performance in functional studies. It achieved a high drug loading efficiency (97.2% ± 1.53%) and remarkable content uniformity (RSD = 1.73%), ensuring consistent dosing. In-vitro release profile revealed an initial burst phase, followed by steady state resulting in complete drug release (91.73%) over 24&#xa0;h. Ex-vivo permeation across rat skin model revealed an excellent enhancement in drug flux (11.76&#xa0;µg/cm²/h), confirming that microneedle patch effectively breached the stratum corneum. Furthermore, insertion capability of optimized patch in a skin model confirmed penetration to adequate depth (~ 500&#xa0;μm) and absence of skin reaction confirmed its biocompatibility. In conclusion, this research successfully established a promising, non-invasive, and more patient compliant platform for transdermal delivery of Granisetron HCl. The optimized fast-dissolving microneedle patch offers a compelling alternative to traditional routes, with strong potential to improve therapeutic efficacy of antiemetic therapy.</p>

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Novel Fast Dissolving Microneedle Patch for Transdermal Delivery of Granisetron; Optimization, In-Vitro and Ex-Vivo Evaluation

  • 期刊论文

  • 发表日期：

    2026年8月3日

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  • Akhtar Ali,
  • Ikrima Khalid,
  • Ikram Ullah Khan

摘要

Management of severe nausea and vomiting in patients undergoing chemotherapy is challenging with traditional drug delivery techniques as emesis itself is a barrier in peroral drug delivery. Moreover, intravenous administration is poorly compliant due to invasiveness, pain and discomfort associated with it. A polymeric microneedle patch (G-FDM) was developed to overcome the drawbacks of conventional drug delivery. The formulation was optimized through 3-level factorial design and comprehensively characterized for transdermal delivery of Granisetron HCl; a vital antiemetic agent. This rigorous optimization process resulted in an ideal formulation (G-FDMo) that demonstrated robust mechanical strength, excellent structural and morphological integrity as confirmed through structural and morphological characterization techniques (SEM, FTIR, DSC and XRD). The optimized patch also exhibited excellent performance in functional studies. It achieved a high drug loading efficiency (97.2% ± 1.53%) and remarkable content uniformity (RSD = 1.73%), ensuring consistent dosing. In-vitro release profile revealed an initial burst phase, followed by steady state resulting in complete drug release (91.73%) over 24 h. Ex-vivo permeation across rat skin model revealed an excellent enhancement in drug flux (11.76 µg/cm²/h), confirming that microneedle patch effectively breached the stratum corneum. Furthermore, insertion capability of optimized patch in a skin model confirmed penetration to adequate depth (~ 500 μm) and absence of skin reaction confirmed its biocompatibility. In conclusion, this research successfully established a promising, non-invasive, and more patient compliant platform for transdermal delivery of Granisetron HCl. The optimized fast-dissolving microneedle patch offers a compelling alternative to traditional routes, with strong potential to improve therapeutic efficacy of antiemetic therapy.