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A Novel Transungual Formulation (Nail Patch) For Delivery of Ciclopirox Olamine into the Nail and the Nail Folds

Biji Palliyil 1 and David B Lebo 1, 2
1 Department of Pharmaceutical Sciences, School of Pharmacy, Temple University, 3307 North Broad Street, Philadelphia, PA 19140.
2 cGMP Services, School of Pharmacy, Temple University, 3307 North Broad Street, Philadelphia, PA 19140.
Abstract—The current work describes (1) development of a transungual patch containing ciclopirox olamine (CPO) and the penetration enhancers (thiourea and propylene glycol); and (2) comparative evaluation of patch against commercially available topical formulation (Penlac <00AE> nail lacquer) for drug delivery into the nail folds and across the nail plate. An immediate release nail patch containing ciclopirox olamine, thiourea and propylene glycol in a HPMC matrix, with a peripheral lining of acrylate PSA (DURO-TAK <00AE> 87-4287) was prepared. The in vitro drug release from the transungual patch was evaluated using USP Apparatus 5. Human cadaver skin was used to determine the in vitro skin permeation and epidermal accumulation of CPO using the nail patch and Penlac <00AE> nail lacquer. The in vitro transungual permeation and ungual delivery of CPO from the two formulations were evaluated using human cadaver toenails. The in vitro release profile shows greater than 80% of drug release within 2 h indicating that the drug release is not the rate limiting step in drug delivery. The nail patch showed significant increase in epidermal accumulation (2.8 fold), transungual permeation flux (4.8 fold), drug concentrations in the receiver compartment (5.2 fold) and in the nail (2.7 fold) compared to the commercial formulation.

Index Terms—Transungual, HPMC, Ciclopirox olamine, On ychomycosis, Penetration enhancers, Antifungal

Cite: Biji Palliyil and David B Lebo, "A Novel Transungual Formulation (Nail Patch) For Delivery of Ciclopirox Olamine into the Nail and the Nail Folds," International Journal of Pharma Medicine and Biological Sciences, Vol. 3, No. 3, pp. 152-164, July 2014.
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