Design and Development of Charantin and Gymnemic Acid Microneedle Based Transdermal Drug Delivery System for Diabetes Management.
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Abstract
The present study focused on the formulation and optimization of dissolving microneedle-assisted transdermal patches containing the phytoconstituents Charantin and Gymnemic acid using a pharmaceutical-grade beeswax mould. Hydrophilic polymers, including polyvinyl alcohol (PVA), polyvinylpyrrolidone K30 (PVP K30), hydroxypropyl methylcellulose E15, and sodium alginate, were screened for their suitability in microneedle fabrication. Preliminary formulations were prepared using PVA, PVP K30, and polyethylene glycol 400 (PEG 400), and evaluated for appearance, microneedle morphology, ease of demoulding, mechanical integrity, flexibility, uniformity of microneedle formation, drug content, swelling behaviour, in vitro drug release, and transdermal flux.
Five preliminary trial batches were prepared with varying concentrations of Charantin and Gymnemic acid. Among these, TB2, containing 5 mg of each phytoconstituent, demonstrated the most satisfactory overall characteristics, including sharp and uniformly formed microneedles, good mechanical strength, flexibility, drug content uniformity of 99.12 ± 0.86%, and cumulative drug release of 96.84 ± 0.92% after 24 hours. Further optimization was performed using a [2^3] full factorial design to investigate the effects of PVA, PVP K30, and PEG 400 concentrations on cumulative drug release and transdermal flux.
The optimized formulation exhibited satisfactory physicochemical and mechanical properties. The factorial batches showed drug release values ranging from 84.36 ± 1.42% to 98.64 ± 0.78%, while the transdermal flux ranged from 162.84 ± 3.12 to 218.76 ± 2.48 µg/cm²/h. Formulation B8, containing 20% PVA, 10% PVP K30, and 15% PEG 400, demonstrated the highest cumulative drug release and transdermal flux. The findings indicate that beeswax mould-based dissolving microneedle patches may provide a promising transdermal delivery platform for Charantin and Gymnemic acid.