Abstract
In vitro permeation studies using nail clippings or nail plates are commonly used in the development of transungual formulations. However, there are ethical, safety and cost issues associated with sourcing such tissues. Herein, we describe a preliminary approach is described for the design and manufacture of a human nail model surrogate based on 3D printing. To evaluate these 3D printed constructs, nails were mounted in conventional glass Franz cells and a commercial antifungal lacquer formulation containing ciclopirox olamine was applied daily to the surrogate printed surfaces for a period of 14 days. On days 8 and 14, the surfaces of the 3D printed nails were washed with ethanol to remove excess formulation. Confocal Raman spectroscopy (CRS) was used to profile the drug in the 3D printed nail. At the end of the Franz cell studies, no drug was observed in the receptor phase. CRS studies confirmed penetration of the active into the model nails with reproducible depth profiles. Our ongoing work is focused on synthesising commercial and non-commercial printable resins that can replicate the physical and chemical characteristics of the human nail. This will allow further evaluation of actives for ungual therapy and advance the development of the surrogate nail tissue model.
Highlights
The nail plate can be characterised as a thin (0.25–0.60 mm length), hard, slightly elastic, translucent and convex structure
The emergence of additive manufacture (AM) technologies such as 3D printing has heralded a new era for the design of non-expensive and efficient reproducible polymeric matrices
Necessary fine-tuning of printing parameters allied with the synthesis of new polymeric resins will allow for more control of the composition and porosity of the nail scaffold going forward
Summary
The nail plate can be characterised as a thin (0.25–0.60 mm length), hard, slightly elastic, translucent and convex structure. Formed by approximately 25 layers of dead keratinised flattened cells, the nail plate is tightly bound via numerous intercellular links, membrane-coating granules and desmosomes [1]. An assessment of the efficacy of new formulations for treatment of nail diseases requires the provision of human nails or an appropriate surrogate tissue. Human nails are difficult to source, variable in quality and their use is associated with ethical and safety issues [2–6]. The emergence of additive manufacture (AM) technologies such as 3D printing has heralded a new era for the design of non-expensive and efficient reproducible polymeric matrices. With printer specifications that can achieve layer thicknesses of ~25 μm and allied with digital design, 3D desktop printers are becoming powerful tools in pharmaceutical research [7–10]. The costs of biocompatible resins allied with the complexities of biological tissues have limited the widespread use of the technology
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