Abstract
BackgroundThe “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.Methodology and FindingsThe 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/SignificanceThe 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.
Highlights
The delivery of medicinal substances across the skin has been limited because of the unique barrier property of the stratum corneum (SC) [1]; barrier defects in the SC layer of the skin allow the penetration of environmental microorganisms into the skin to produce immunological reactions and inflammation [2]
polylactic-coglycolic acid (PLGA) is a material that can degrade over the course of months [10], and according to Park et al (2006) 80% of bovine serum albumin (BSA) was released over 5 days from PLGA matrix, where the kinetic was controlled by the degradation of the PLGA microneedle arrays (MNs) [11]
The major aim of this study was investigation of the BSA permeation profiles obtained with conventional sodium alginate (SA) patches and the formerly microfabricated soluble polymeric microneedles (SA MNs) [27], which had a height of 900 mm, a width of 250 mm, an inter-base spacing of 500 mm, and an apex diameter of 100 mm
Summary
The delivery of medicinal substances across the skin has been limited because of the unique barrier property of the stratum corneum (SC) [1]; barrier defects in the SC layer of the skin allow the penetration of environmental microorganisms into the skin to produce immunological reactions and inflammation [2]. Skin is a unique portal for vaccine administration and contains an abundance of immunocompetent cells [5,6], numerous application strategies have been utilized for drug/vaccine delivery through painless piercing matrix systems, microneedle arrays (MNs), across the skin. PLGA is a material that can degrade over the course of months [10], and according to Park et al (2006) 80% of bovine serum albumin (BSA) was released over 5 days from PLGA matrix, where the kinetic was controlled by the degradation of the PLGA MN [11]. 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
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