Abstract
BackgroundOptimising intranasal distribution and retention of topical therapy is essential for effectively managing patients with chronic rhinosinusitis, including those that have had functional endoscopic sinus surgery (FESS). This study presents a new technique for quantifying in vitro experiments of fluticasone propionate deposition within the sinuses of a 3D-printed model from a post-FESS patient.MethodsCircular filter papers were placed on the sinus surfaces of the model. Deposition of fluticasone on the filter paper was quantified using high-performance liquid chromatography (HPLC) assay-based techniques. The deposition patterns of two nasal drug delivery devices, an aqueous nasal spray (Flixonase) and metered dose inhaler (Flixotide), were compared. The effects of airflow (0 L/min vs. 12 L/min) and administration angle (30° vs. and 45°) were evaluated.ResultsInhaled airflow made little difference to sinus deposition for either device. A 45° administration angle improved frontal sinus deposition with the nasal spray and both ethmoidal and sphenoidal deposition with the inhaler. The inhaler provided significantly better deposition within the ethmoid sinuses (8.5x) and within the maxillary sinuses (3.9x) compared with the nasal spray under the same conditions.ConclusionIn the post-FESS model analysed, the inhaler produced better sinus deposition overall compared with the nasal spray. The techniques described can be used and adapted for in vitro performance testing of different drug formulations and intranasal devices under different experimental conditions. They can also help validate computational fluid dynamics modelling and in vivo studies.
Highlights
Chronic rhinosinusitis (CRS) represents a spectrum of disorders resulting from complex immunopathological responses that lead to persistent inflammation of the paranasal sinus mucosa
This study aimed to design and perform in vitro experiments allowing the quantification of topical fluticasone propionate deposition within the sinuses of a single highly detailed threedimensional (3D) printed model of a post-functional endoscopic sinus surgery (FESS) patient by two commercially available devices: 1) Flixonase nasal spray (GlaxoSmithKline, UK) 2) Flixotide metered dose inhalers (MDIs) (GlaxoSmithKline, UK)
A total of 16 data points were collected for each site with no Optimal device for sinus deposition using limited sampling
Summary
Chronic rhinosinusitis (CRS) represents a spectrum of disorders resulting from complex immunopathological responses that lead to persistent inflammation of the paranasal sinus mucosa. In patients who fail to respond adequately to medical therapy, functional endoscopic sinus surgery (FESS) is indicated. This procedure opens the obstructed sinus openings (ostia) in order to improve sinus ventilation and restore mucociliary clearance. Without long-term topical postoperative medical management, these cases have a significant risk of requiring revision surgery. Topical corticosteroids are the mainstay of postoperative therapy for effective long-term management [2, 3]. It remains uncertain how efficiently these are. Optimising intranasal distribution and retention of topical therapy is essential for effectively managing patients with chronic rhinosinusitis, including those that have had functional endoscopic sinus surgery (FESS). This study presents a new technique for quantifying in vitro experiments of fluticasone propionate deposition within the sinuses of a 3D-printed model from a post-FESS patient
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