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Characterizing Nasal Suspensions for Regulatory and Scientific Purposes

Shur J, Farias G, Huck-Jones DM, O'Grady C, Saluja B, Price R.

Respiratory Drug Delivery 2016. Volume 1, 2016: 185-192.

Abstract:

Demonstrating bioequivalence (BE) of nasal suspension sprays is a challenging task. Analytical tools are required to determine particle size of the active pharmaceutical ingredient (API) and the structure of a relatively complex formulation. This study investigated the utility of the Morpologi- G3-ID to investigate the particle size distribution (PSD) of nasal sprays formulated with APIs in suspension. Rotational rheometry and force required to actuate during dose delivery was used to investigate formulation structure. A systematic approach was utilized to develop a robust method for the analysis of the PSD of mometasone furoate in Nasonex^® and two test formulations containing the API with different particle size specifications. One test formulation API PSD suggested that the drug may have undergone Ostwald ripening in the formulation, but both were distinct and distinguishable from Nasonex and each other. Rheometric measurements were sensitive to variations in Avicel^® content and, at lower Avicel concentrations than Nasonex, exhibited different gel-like and shear-thinning properties. This was confirmed by measurement of the force to fire measurements during dose delivery. Together, these analytical methods may facilitate the determination of critical material and process attributes that may affect drug product quality.