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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.

Objectives: The objective of the research was to prepare and evaluate the cosmetic gel containing SLNs of Kappaphycus alvarezii chloroform extract to localize the extract topically to exert its antimicrobial properties. Methodology: The antimicrobial activity evaluation for the chloroform, methanol, and aqueous K. alvarezii extracts were carried out using disc-diffusion agar plate method. The extract with maximum antimicrobial action was selected for the preparation of SLNs. Pre-formulation studies using ATR-FTIR spectrophotometer was carried out to check the compatibility of the extract with excipients in the range of 400–4000 cm−1.The SLNs were prepared by the film hydration technique with ultrasonication. The dried SLNs were evaluated for its physical characteristics, zeta potential and for the duration taken to release the encapsulated extract for the antimicrobial action. Carbopol and HPMC were chosen as the gelling agent after compatibility studies with nanoparticle dispersions.The extract loaded SLNs based gel was analysed for its pH, visual appearance, and in-vitro drug release. Results: Chloroform extract of K. alvarezii (120μg) showed maximum antimicrobial activity with cloudy and blurry zone of inhibition. The zone of inhibition was smaller for SLNs when compared to the extract. This was due to the low diffusion of encapsulated drug through the outer lipid layer of SLNs. SLNs showed a zeta potential ranging between –11.0 to –37.4mV. The formulated gel containing solid lipid nanoparticles of chloroform extract of K. alvarezii had an average pH value of 5.37, which was suitable to be used on human skin. The maximum drug release was 60.28% for over a period of 25 hours. Conclusion: In this study algal extracts were successfully encapsulated within the SLNs and when applied topically the SLNs could reside on the surface of the skin for localized action as evident from the drug release study.The zeta potential obtained for the SLNs was approximately within the limit of –30mV that yields a formulation with fairly good physical stability.

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