The US FDA and EMA recently issued industry guidance focused on reducing risk associated with medication errors and improving patient compliance. Recommendations are that varying color, shape, and size between dose strengths of a solid oral medication are useful tools to improve differentiation and minimize potential for errors. Additionally, visual differentiation of immediate and modified release dosage forms of the same drug is essential to ensure overall patient safety. Understanding the marketed product landscape for targeted therapeutic categories can help formulators better design a dosage form that is memorable and patient centric. Addition of a fi lm coating on tablets is also clearly recommended in the guidance to improve patient compliance by enhancing the patient’s ability to swallow tablets. In this study a developmental fi lm coating system has been evaluated to demonstrate wet slip behavior as an indication to provide improved swallowability.
The clear and pigmented developmental film coatings demonstrated exceptional wet slip behavior. Application of the developmental clear coating imparted excellent wet slip behavior to both the hypromellose and PVA-based coated tablets, while also improving the glossy appearance. Enhancing slip provides a way to improve tablet swallowability and enhance patient compliance.
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Daniel To, Jeff Gimbel, Jason Teckoe, Rita Steff enino and Ali Rajabi Siahboomi
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