Determination of the influencing factors on in vitro performance of a marketed OTC nasal spray product using a Quality by Design (QbD) and Design of Experiments (DOE) approach

Poster presented at Respiratory Drug Delivery Conference Asia 2014.

Farina DJ, Pitluk Z, Mayer WJ, Falatico M, De S; RDD Asia 2014. Volume 1, 2014: 215-220.

INTRODUCTION: Determining the influencing factors related to in vitro performance of nasal sprays is essential for establishing robust release specifications, label claims, and product understanding consistent with current Food and Drug Administration (FDA) and International Conference on Harmonization (ICH Q8,R2) guideline [1,2]. The main purpose of this work was to show how as a systematic approach with modern design of experiments (DoE) and quality by design (QbD) practices can yielda wealth of product knowledge on a marketed nasal spray product for shot weight, spray pattern, and droplet size distribution in vitro performance. Moreover, with the 2013 FDA Advisory Panel recommendation to allow Nasacort AQ nasal spray (Triamcinolone) to be available as an over the counter product (OTC), deeper product knowledge gained from the approach shown in this poster could help regulatory, quality assurance, and business people when making the Rx-OTC transition [3] (e.g testing of the contain closure system in a way that simulates actual product usage [2, Section 2.4].

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