Abstract: The present invention relates to a solid oral pharmaceutical composition that includes: (a) an active pharmaceutical ingredient; (b) a nitrosamine inhibitor that includes linear or branched C1-C10 alkyl 3,4,5-trihydroxybenzoate; and (c) a pharmaceutically acceptable excipient. At least one of: (i) the active pharmaceutical ingredient includes at least one covalently bonded amine group that is subject to conversion to nitrosamine; or (ii) the solid oral pharmaceutical composition includes at least one amine, that is other than the amine group covalently bonded to/within the active pharmaceutical ingredient, and which is subject to conversion to nitrosamine. The nitrosamine inhibitor is present in an amount at least sufficient to reduce the amount of nitrosamine formed in the solid oral pharmaceutical composition, compared to the amount of nitrosamine formed in a comparative solid oral pharmaceutical composition that is free of the nitrosamine inhibitor.

Abstract: Apparatus and an associated method are provided for nondestructively inspecting a coated article which may be a coated drug unit to determine the extent of coating on the exterior thereof. A probe may be received within a housing wherein the article is coated and transported as in a fluidized bed. A probe which has a recess for receiving coated article and a communicating fiberoptic receiving passageway. The recess receives a single coated article or plurality of coated articles on which light, which is preferably near-infrared light, is caused to impinge by a first group of fiberoptic fibers with the reflected light being delivered from the coated article to a spectrometer which analyzes the coating information. A microprocessor may be employed to control the inspection process, as well as the coating system. The probe may be rotatably mounted within the housing to facilitate removal of the coated article after inspection under the influence of gravity.