Tablets & Capsules


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S 12 April 2014 Tablets & Capsules tablet coating Avoiding defects in film-coated tablets Beverly Schad Sensient Pharmaceutical This article outlines how the tablet core, coating solution, and equipment should interact to produce uniformly coated tablets. It also discusses the importance of selecting a plasticizer and sum- marizes how process settings affect the quality of the film coat. To determine where to start, the coating supplier must have a basic understanding of the API and the other com- ponents in the tablet core, the release mechanism, and the intended critical quality attributes (CQAs). Some CQAs may be aesthetic, such as coating gloss and logo definition, while others may pertain to function, such as smoothness for better swallowability. The coating may also need to provide processing advantages that reduce manufacturing costs. Selecting a coating that is appropriate begins with a review and understanding of each candidate coating's components and an assessment of their compatibility with the components of the tablet core. Formulators must also assess how the coating process—from solution preparation to coating application—could lead to tablet defects. uppliers of polymer-based coating systems must develop formulation approaches that accommodate the unique characteristics of active pharmaceutical ingredi- ents (API). Some APIs are sensitive to moisture, light, or heat, and some have undesirable tastes or odors that the coating must mask. In addition, the coating must main- tain the API's stability and support its bioavailability, which may require an enteric coating or a coating that supports controlled or immediate release. All of this must be done without causing tablet defects. c-Schadart_12-19REV_Masters 4/8/14 10:52 AM Page 12

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