D. Farina. Poster presented at AAPS Annual Meeting and Exposition 2008; 2008 Nov 16 – 20; Atlanta, GA.

INTRODUCTION: The purpose of this presentation is to describe the holistic Proveris by Design™[1] methodology for characterizing pMDI performance using quality by design (“QbD”) principles advocated by the FDA and industry [2][3][4], and to apply the methodology to a commercially representative product. A commercially available pMDI product was characterized using the patented Proveris by Design process. Results included measurements of the product’s Design Space based on manual actuation using male and female trained testers. The Control Space was determined from the Design Space measurements and the Operating Space was confirmed using metered spray weight measurements. The Plume Geometry performance of the product was determined using Proveris’s patented SprayVIEW® equipment running Viota® software.

BACKGROUND: The current FDA guidance documents related to in vitro testing of nasal spray and inhalation solution, suspension and spray drug products [5], recommends the use of automated actuation systems to perform the in vitro tests for these spray drug products and that settings for these systems should be relevant to proper usage of the product by trained patients. Furthermore, where actuation settings are not available from the pump supplier, the guidance document specifies that “settings should be documented based on exploratory studies in which the relevant parameters are varied to simulate in vitro performance upon hand actuation.” The Proveris by Design process presented here leverages this recommendation to significantly streamline product development efforts and simplify the transfer of development methods to the production arena.

Organizations that have followed the Proveris by Design process typically save 12-18 months of development time resulting in millions of dollars of cost savings, significantly reduce the risk associated with nasal and aerosol product development, all while improving the quality of regulatory submission packages (e.g. ANDA, NDA, IND) and promoting PAT and QbD principles now advocated by the FDA [2][3][4].