ANYL 61 |
| Metal induced photodegradation was characterized for drug molecule Compound A (Scheme 1; UVmax: 285nm) under ultraviolet and/or visible light stress conditions. Structural identification of the degradation products suggested an oxidative degradation pathway. This metal-sensitized photodegradation does not appear to occur via Fenton chemistry, but rather is attributed to direct drug-metal complexation. The UV absorption spectrum of Compound A is significantly extended from <300nm to >400nm upon complexation, resulting in the transformation from a photostable to a photolabile drug molecule. The metal-drug complexation and subsequent photoxidation were demonstrated in both the solution and solid states. These findings suggest that the photochemistry of a drug molecule could be altered during formulation processes, such as wet granulation or hot melt extrusion. During these processes, excipient metal impurities may potentially complex with the drug substance ultimately leading to photo-instability in the drug products.
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General Papers
7:00 PM-9:00 PM, Sunday, 10 September 2006 Moscone Center -- Hall D, Poster
Division of Analytical Chemistry |
