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<p>This research focuses on enhancing the bioavailability of Raloxifene Hydrochloride(RLX) through a novel microneedle(MN) system embedded with hydroxyapatite (HAP) nanoparticles for transdermal delivery. The aim was to develop a microneedle-based formulation using HAP nanoparticles that could synergize with RLX’s anti-osteoporotic action. HAP nanoparticles were synthesized using chemical precipitation and optimized using Box-Behnken design. These nanoparticles were incorporated into a PVA-PVP polymer matrix and moulded into fast-dissolving MNs using a micro-moulding approach. The optimization of the formulation variables for MN preparation was performed by 3² full factorial design. Characterization of the nanoparticles included evaluation of particle size, zeta potential, drug entrapment, TEM, XRD, FTIR, and DSC. The MNs were tested for morphology, mechanical strength, drug content, penetration capacity, in-vitro and ex-vivo drug release. Results demonstrated that the MNs had sharp tips, good mechanical integrity, and dissolved quickly upon application. Ex-vivo studies confirmed significantly enhanced drug permeation compared to the conventional forms. Histological analysis revealed successful microporation of the skin. Notably, a 5.56-fold increase in bioavailability was achieved with the MN patches compared to oral delivery. This innovative system shows strong potential for transdermal osteoporosis therapy and warrants further exploration via biodistribution studies.</p>

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Fast Dissolving Microneedle of Raloxifene Hydrochloride Loaded Hydroxyapatite Nanoparticle: In-Vitro, Ex-Vivo and In-Vivo Characterization

  • 期刊论文

  • 发表日期：

    2026年2月16日

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  • Drashti Goinawala,
  • Sweety Patel,
  • Dhruvi Rana,
  • Zeel Prajapati,
  • Hetal P. Thakkar

摘要

This research focuses on enhancing the bioavailability of Raloxifene Hydrochloride(RLX) through a novel microneedle(MN) system embedded with hydroxyapatite (HAP) nanoparticles for transdermal delivery. The aim was to develop a microneedle-based formulation using HAP nanoparticles that could synergize with RLX’s anti-osteoporotic action. HAP nanoparticles were synthesized using chemical precipitation and optimized using Box-Behnken design. These nanoparticles were incorporated into a PVA-PVP polymer matrix and moulded into fast-dissolving MNs using a micro-moulding approach. The optimization of the formulation variables for MN preparation was performed by 3² full factorial design. Characterization of the nanoparticles included evaluation of particle size, zeta potential, drug entrapment, TEM, XRD, FTIR, and DSC. The MNs were tested for morphology, mechanical strength, drug content, penetration capacity, in-vitro and ex-vivo drug release. Results demonstrated that the MNs had sharp tips, good mechanical integrity, and dissolved quickly upon application. Ex-vivo studies confirmed significantly enhanced drug permeation compared to the conventional forms. Histological analysis revealed successful microporation of the skin. Notably, a 5.56-fold increase in bioavailability was achieved with the MN patches compared to oral delivery. This innovative system shows strong potential for transdermal osteoporosis therapy and warrants further exploration via biodistribution studies.