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Stability Studies of a PEG-Free, PVA-Based Film Coating System Jason Teckoe, Allison Labriola, Jason Hansell, Tom Farrell and Ali Rajabi-Siahboomi Poster Reprint AAPS 2012 Purpose Polyvinyl alcohol (PVA-based) film coatings have been used successfully on a wide range of drug and nutritional supplement products globally since they were introduced by Colorcon in the 1990s.1 The success of these coating systems has been due to their ability to provide excellent aesthetic performance as well as superior moisture and oxygen barrier properties. In addition, the Opadry® II PVA-based coatings are high productivity systems with high solids and high spray rates resulting in reduced coating process times. The key to achieving high spray rates with the Opadry II PVA-based coatings is the use of polyethylene glycol (PEG) as a detackifing agent. While the use of PEG in film coatings leads to stable drug products in the great majority of cases, there have been instances where PEG has been found to cause instability issues. It has been reported that PEG can degrade oxidatively to formic acid and formaldehyde, which may react with some APIs.2,3 In addition, PEG can promote color fading of the film coating through oxidation chemistry or due to its mobility under high temperature and humidity conditions.4 In order to address these potential issues, PEG-free, PVA-based coatings retaining the benefits of high productivity and superior barrier properties have been developed by Colorcon. The purpose of this work was to investigate the levels of formic acid and formaldehyde in a PEG-free, PVA-based film coating system and color stability of coated tablets following storage at ICH accelerated