Evaluation of a New Film-Coating System for Temperature Sensitive Active Pharmaceutical Ingredients

Many API’s and excipients are heat sensitive. This can prove problematic when using regular film coating systems based on HPMC or PVA because high temperatures are required in order to efficiently apply a uniform coating. If the elevated temperatures are not used, a variety of issues related to over-wetting may occur. The objective of this study was to evaluate the performance of a modified pea starch polymer based coating formulation processed at a tablet bed temperature lower than 25 C.

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