Pharmaceutical properties of fluticasone propionate nasal drops: a new formulation

A variety of corticosteroid delivery systems have been considered for the t reatment of nasal polyposis. Safety considerations favour local delivery of the drug to the nasal cavity. No topical delivery system is entirely witho ut problems, however, and formulations must address issues of microbiologic al quality, drug stability, reproducible drug delivery and adequate drug di stribution at site, while also offering environmental and patient acceptabi lity. Fluticasone propionate has been formulated in a new nasal drop prepar ation. As a highly water-insoluble compound, the active fluticasone propion ate requires micronization to an optimal particle size and subsequent dispe rsion with a surface-active wetting agent. The product is presented in a un it dose low-density polyethylene container, manufactured by a blow-fill-sea l process and stored in an aluminium foil over-wrap. Micronized active has been used to promote optimal local drug delivery, and excipients have been selected for low irritancy potential and high formulation stability. There is no microbiological risk with fluticasone propionate unit dose nasal drop s 400 mu g and therefore no need to include a preservative in the preparati on. They provide a convenient and effective treatment option for patients w ith nasal polyposis.