Abstract
Nail patches have a potential role as drug carriers for the topical treatment of nail diseases such as onychomycosis, a common condition. Our aim was therefore to develop a systematic and novel approach to the formulation of a simple drug-in-adhesive ungual patch. Twelve pressure-sensitive adhesives (PSAs), four backing membranes, two release liners and three drugs were screened for pharmaceutical and mechanical properties. From this initial screening, two PSAs, two drugs, one backing membrane and one release liner were selected for further investigation. Patches were prepared by solvent-casting and characterised. The patches had good uniformity of thickness and of drug content, and showed minimal drug crystallisation during six months of storage. Meanwhile, the drug stability in the patch upon storage and patch adhesion to the nail was influenced by the nature of the drug, the PSA and the backing membrane. The reported methodology paves the way for a systematic formulation of ungual nail patches to add to the armamentarium of nail medicines. Further, from this work, the best patch formulation has been identified.
Highlights
Onychomycosis, the fungal infection of the nail unit, affects 14–18% of the general population worldwide [1], and has been called a ‘stubborn clinical problem’ [2]
It can be seen that the experimentally-determined δD, δP and δH parameters reflected the chemical structures of the pressure-sensitive adhesives (PSAs)
Our aim was to develop a new systematic approach to the formulation of drug-in-adhesive anti-onychomycotic nail patches, and in this paper, we demonstrate a possible pathway for such patch development
Summary
Onychomycosis, the fungal infection of the nail unit, affects 14–18% of the general population worldwide [1], and has been called a ‘stubborn clinical problem’ [2]. Significant negative impact on sufferers’ quality of life [3] and current treatment limitations such as liver toxicity of oral drugs and low cure rates of approved topical medicines [4], demand new therapeutic approaches. We have studied the development of anti-onychomycotic nail patches. Topical therapy is highly desirable for its avoidance of systemic adverse effects and drug interactions. Nail patches have been investigated the literature is very limited. It includes investigations into the influence of patch components on ungual (i.e. of the nail) drug permeation [7,8], testing of sertaconazole-containing patches in human volunteers[9], and the use of patches in photodynamic therapy of onychomycosis [10] and in iontophoretic ungual drug delivery[11]
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