RESUMO
Amorphous solid dispersions (ASDs) have been widely utilized to enhance the bioavailability of pharmaceutical drugs with poor aqueous solubility. The role of various excipients on the amorphous drug to crystalline form conversion in ASDs has been widely documented. However, there has been no published study to investigate the role of film coating material on the physical stability of an ASD based tablet formulation, to the best of our knowledge. Here we show that the film coating can potentially have a detrimental impact on the physical stability of spray dried intermediates (SDI) in tablet formulations. The impact of the film coating on the physical stability of SDI was found to be related to the film coat material composition, and an increase in the film coating thickness led to a reduction in the physical stability of SDI in tablets. Oral compressed tablets in which the film coat material was "mixed-in" with the formulation blend showed a similar or worse physical stability than film coated tablets, further underscoring the film coat material impact on physical stability, independent of the film coating process. This study demonstrates a need for careful consideration of the film coat material selection for ASD based pharmaceutical product development.