Study on Swallowability of EUDRAGIT® Coated Tablets

A swallowing disorder, known as dysphagia, is a phenomenon of increasing prevalence. It may occur because of various medical conditions involving the oral cavity, the pharynx, the esophagus, and the gastro-esophageal junction. The US FDA and the EMA have provided guidance addressing the importance of tablet coating to not only ensure differentiation, but also to ease the swallowing of oral solid dosage forms, in order to improve patient safety and compliance1, 2, 3.

For evaluating the ease of swallowability of tablets coated with EUDRAGIT® in comparison to other commercially available coating systems, 12.5 mm circular flat-faced caffeine tablets were coated to a solid weight gain of 5% w/w in a perforated coating pan using the following polymers:

  1. EUDRAGIT® E PO (Evonik Nutrition & Care GmbH, Germany)
  2. EUDRAGIT® L 30 D-55 (Evonik Nutrition & Care GmbH, Germany),
  3. EUDRAGIT® FS 30 D (Evonik Nutrition & Care GmbH, Germany)
  4. Opadry® (HMPC based) (Colorcon Inc., USA)
  5. Opadry® AMB (PVA based) (Colorcon Inc., USA)
  6. Opadry® EZ (Colorcon Inc., USA)

Batch size was 800 grams in all cases, and the processing conditions were based on the standard recommendations4,5.

Read more in the LinkedIn article of Brigitte Skalsky

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