Abstract
Chronic onychomycosis, frequently caused by candida species poses a significant therapeutic and financial challenge for low-income patients due to poor drug penetration through the nail plate. This study aimed to develop a cost-effective, high penetration topical Oleogel loading Terbinafine HCL (1%) and ceramide (0.5%) to synergize antifungal eradication with nail barrier repair. The formulation utilized Jojoba oil, Palmitic acid (10%), and span60(7%). In-vitro drug release was evaluated using a Franz diffusion cell with a dialysis membrane in a single biorelevant medium. To ensure successful transungual delivery to the subungual tissue, ex-vivo permeation studies were conducted across a fabricated bovine hoof membrane (0.6mm thickness), under two distinct microenvironments: acetate buffer (pH5.5, stimulating the nail surface) and phosphate buffer saline (pH7.4, stimulating the nail bed fluid). The developed oleogel was compared with a commercial reference cream (TamifenTM, jamjoom pharma). against Candida albicans and candida tropicalis. The optimized oleogel exhibited an exceptional sustained release profile, delivering a controlled cumulative release of 90% over 8 hours.in permeation study, the oleogel demonstrated superior, pH-dependent transungual penetration; it achieved a controlled cumulative permeation of 92% over 10 hours at pH 5.5 and 92% over 6 hours at pH 7.4. conversely, the commercial Terbinafine Hcl cream exhibit an abrupt burst release 79% within 2 hours, and rapid, short-lived permeation 95% in 4 hours at pH 5.5 and 96.5% within 3 hours at pH 7.4. Microbiologically, although aqueous microdilution biased lower MICs for the cream (R.c) over the oleogel (R. g) against C. albicans (6.25 vs 50mg/ml), and C. trophicalis (0.781vs 6.25mg/ml), the anhydrous oleogel acts as a biomimetic sustained release vehicle, exploiting Candida lipolytic physiology to target and bypass rigid transungual barrier. the developed oleogel successfully penetrates the tough nail barrier to reach the deep nail bed environment.it offers a novel, sustained release, and economically accessible alternative that outclasses traditional commercial cream, ensuring both clinical efficacy and patient compliance.
| Has the manuscript been published | not published |
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| Intend to be published in the IJPS ? | Yes |
