Characterization of Dose Delivery and Spray Pattern of a Metered-Dose Flunisolide Nasal Spray

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Abstract
Flunisolide is a synthetic fluorinated corticosteroid with significant ant -inflammatory and anti-allergic activities. Flunisolide nasal solution (Nasalide®) is delivered by a unique pump-activated, non-propellant, metered-dose device. A previous paper (1) reported droplet size characterization of the nasal spray by a cascade impactor. This report describes the remaining physical characterizations, namely dose delivery and spray pattern, of this metered-dose delivery system as well as the suitability of the system for a therapeutic corticosteroid nasal solution. Actuation of flunisolide nasal spray units by 10 subjects over time demonstrated good constancy of dose delivery for up to 24 days of use. The average dose delivery was 0.737 ± 0.040 gm/day (grand mean ± s.d.). Actuation of similar units by 17 subjects over time showed good constancy of spray pattern, which was defined as the long and short diameters of the impaction pattern of the spray on a TLC plate, for the entire lifetime of the unit.

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