Objectives: Microneedles transdermal patches is the combination between hypodermic needles and transdermal patches to overcome the individual limitations of both injections and patches. The objective of this study was to design a minimally invasive biodegradable polymeric recombinant human keratinocyte growth factor (rHuKGF) microneedles array and evaluate the prepared biodegradable microneedles using in-vitro techniques. Materials and Method: Biodegradable polymeric microneedles arrays were fabricated out of poly lactic-co-glycolic acid (PLGA) using micromoulding technique under aseptic conditions and the morphology of the microneedles were characterized using light microscope. Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis (SDS-PAGE) was used to rule out drug polymer interaction. Standard procedures were used to analyze the prepared microneedles arrays for invitro drug release and microneedles insertion test. Enzyme-linked Immunosorbent Assay (ELISA) was used to quantify rHuKGF. Results. PLGA polymer was safe to be used for fabrication of rHuKGF microneedles as there was no interaction between drug and polymer. The fabricated rHuKGF microneedles arrays had fully formed microneedles with the height of 600 µm and base of 300 µm. The drug from the microneedles patch was released in-vitro within 30 minutes. The strength of microneedles in the patch was good as it was able to reach the depth of 381 ± 3.56 µm into parafilm without any structural change or fracture. Conclusion: Microneedles transdermal patches were successfully prepared for rHuKGF and their evaluation suggested excellent quality and uniformity in patch characteristics. This can have potential applications in therapeutic arena offering advantages in terms of reduced dosing frequency, improved patients' compliance and bioavailability.
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