Development, characterisation and evaluation of sugar glass microneedles

摘要: Biodegradable microneedles (MNs) are currently being developed to painlessly facilitate the effective permeation of therapeutic substances across skin barrier. As sugar glasses utilised in nature protect proteins and other delicate structures upon dehydration, such materials may be an appropriate substrate for preparation biodegradable MNs. The aim this work was investigate first time feasibility preparing MNs from test their potential utility drug delivery applications. Solid products were fabricated 32 different solutions containing a range individual sugars binary combinations, utilising low temperature dehydration methodology. Subsequently, novel vacuum-forming micromoulding methodology optimised produce glass microneedle (SGMN) arrays silicon master structures. MN characterised using variety microscopic, thermal x-ray diffraction analyses. ability SGMNs puncture human assessed vitro model, whilst SGMN facilitated investigated modified static Franz-type diffusion cells. A model including methylene blue (MB) dye, ibuprofen sodium (IBU), sulforhodamine B (SRB), FITC-BSA β-galactosidase (β-gal) incorporated within arrays. Furthermore, adhesive patches SRB backing only silicone acrylate adhesives. Long-term stability under differing storage conditions. Initial characterisation studies suggested that non-crystalline material formed anhydrous trehalose sucrose (75:25 %w/w) solutions. This finding critical future fabrication incorporation material. Process optimisation led with strong morphological fidelity structures, which reliably penetrated MB dye. shown dissolve rapidly completely deliver MB, IBU, deeper layers. Diffusion study data incorporating bolus manner. Additionally, it found able control SRB, hydrophilic compound. Sugar β-gal stabilise enzyme functionality at approximately 40 % initial activity over 3 month period when stored desiccation. Elevated humidity detrimental morphology, 10 relative 20 °C optimal preservation. Overall, suggests stable intra- or trans-dermal substances, macromolecular molecules. patch provide capability release skin. demonstrated stabilising effect functional protein cargo, although appeared conditions had influence physical stability.