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Microneedle-Mediated Transdermal Delivery of Bevacizumab
Courtenay, Aaron J.,McCrudden, Maelí,osa T. C.,McAvoy, Kathryn J.,McCarthy, Helen O.,Donnelly, Ryan F. American Chemical Society 2018 Molecular pharmaceutics Vol.15 No.8
<P>Bevacizumab is a recombinant humanized monoclonal antibody used clinically as a combination chemotherapeutic. Antibody therapeutics are usually formulated as parenteral injections, owing to their low oral bioavailability. Microneedle technology provides a transdermal alternative for drug-delivery using micron-scale needle structures to penetrate directly through the <I>stratum corneum</I> into the dermal interstitium. This study describes the design, formulation, and <I>in vitro</I> characterization of both dissolving and hydrogel-forming microneedle array platforms for transdermal delivery of bevacizumab. Bevacizumab recovery and transdermal permeation studies were conducted and analyzed using bevacizumab specific ELISA. Prototype microneedle-patches were tested <I>in vivo</I> in Sprague-Dawley rats with serum, exterior lumbar and axial lymph nodes, spleen, and skin tissue concentrations of bevacizumab reported. This work represents the first example of high dose transdermal delivery of an antibody therapeutic <I>in vivo</I> using dissolving and hydrogel-forming microneedle platforms. Basic pharmacokinetic parameters are described including hydrogel-forming microneedles: <I>C</I><SUB>max</SUB> 358.2 ± 100.4 ng/mL, <I>T</I><SUB>max</SUB> 48 h, AUC 44357 ± 4540, and <I>C</I><SUB>ss</SUB> 942 ± 95 ng/mL, highlighting the potential for these devices to provide sustained delivery of antibody therapeutics to the lymph and systemic circulation. Targeted delivery of chemotherapeutic agents to the lymphatic system by MN technology may provide new treatment options for cancer metastases.</P> [FIG OMISSION]</BR>