Abstract
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, the oleogel demonstrated vastly superior potency, achieving a lower MIC (minimum inhibitory concentration) against Candida albicans (0.001µg/ml of oleogel vs. 0.02µg/ml of cream). Candida tropicalis (0.01µg/ml of oleogel vs. 0.04µg/ml of cream). 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.
Keyword: Terbinafine Hcl-Ceramide NP, Oleogel, natural oil, palmitic acid, Candida species, Transungual Delivery
| Intend to be published in the IJPS ? | Yes |
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| Has the manuscript been published | not published |
