Department of Pharmaceutical Technology, Marmara University Faculty of Pharmacy, Istanbul, Turkey.
PLoS One. 2013 May 10;8(5):e63819. doi: 10.1371/journal.pone.0063819. Print 2013.
The "poke and release" strategy for the delivery of macromolecules using polymeric microneedle (MN) is of great importance because it eliminates microneedle reuse, the risks of biohazardous sharps and cross contamination, and it requires no special disposal mechanism. The main objective of this study was the determination of the stability and delivery of bovine serum albumin (BSA) that was transported across human skin via sodium alginate (SA) microneedle arrays (MNs) and SA needle free patches using two different analytical methods.
The capability of two analytical methods, the bicinchoninic acid (BCA) assay and sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), to precisely detect and quantify BSA within different types of polymeric MNs was assessed. The ex vivo protein release of BSA across dermatomed human abdominal skin from 10 w/w SA MNs was compared to that from needle-free patches using Franz diffusion cells. The developed applicator was mechanically characterized using a Texture Analyzer. The patch mold and its components were fabricated using a rapid prototyping machine.
CONCLUSIONS/SIGNIFICANCE: The BCA method was able to precisely detect BSA that had been loaded into SA MNs. However, the use of SDS-PAGE as the analytical method resulted in significantly different amounts of BSA recovered from differently conditioned polymeric MNs. The permeation of BSA across dermatomed human abdominal skin by SA MNs, which were composed of 100 pyramidal needles, increased by approximately 15.4 fold compared to the permeation obtained with SA needle-free patches. The ease of use of the applicator during the release studies was also demonstrated, as was its mechanical characterization.
使用聚合物微针（MN）进行大分子传递的“戳刺和释放”策略非常重要，因为它消除了微针的重复使用、生物危害锐器和交叉污染的风险，并且不需要特殊的处理机制。本研究的主要目的是确定牛血清白蛋白（BSA）的稳定性和传递，该蛋白通过海藻酸钠（SA）微针阵列（MN）和无针 SA 贴片穿过人体皮肤运输，使用两种不同的分析方法。
评估了两种分析方法，即双缩脲（BCA）测定法和十二烷基硫酸钠聚丙烯酰胺凝胶电泳（SDS-PAGE），以精确检测和定量不同类型聚合物 MN 中的 BSA。使用 Franz 扩散细胞比较了 10 w/w SA MN 从去皮人腹部皮肤释放 BSA 的体外蛋白释放情况与无针贴片的释放情况。使用质地分析仪对开发的敷贴器进行了机械特性表征。使用快速成型机制造了贴片模具及其组件。
结论/意义：BCA 方法能够精确检测加载到 SA MN 中的 BSA。然而，使用 SDS-PAGE 作为分析方法会导致从不同条件下的聚合物 MN 中回收的 BSA 数量显著不同。由 100 个金字塔形针组成的 SA MN 使 BSA 穿过去皮的人腹部皮肤的渗透增加了约 15.4 倍，与使用无针 SA 贴片获得的渗透相比。还证明了在释放研究过程中敷贴器的易用性及其机械特性。
