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photos in Figure 3 show how the capsules and their fill appeared after dissolution testing. Conclusions Filled manually, the enteric-coated empty capsule shells described here performed well. However, they may not perform as well on high-speed encapsulation equip- ment and thus commercial application of the technique may be limited. Nonetheless, it is useful in providing acid resistance during non-traditional, early phase-1 formula- tions for evaluation and screening studies. Indeed, the coated capsules offered a faster path to an enteric-coated product for acid-labile compound drugs than was possible using other dosage forms, such as tablets or pellets, that require more elaborate formulation and coating processes. The coating method is easy to use and can be applied at advanced clinical stages. Furthermore, the empty cap- sules enable development scientists to adjust the size of the dose easily. There are many types of enteric coatings that can be used. In this case, it was an aqueous film coat- ing, which eliminated concerns about a non-aqueous sol- vent entering the finished product. Finally, the Wurster process is efficient and ideal for empty capsules com- pared to the conventional pan coating because it is more gentle and easier to observe. T&C Yogesh Chachare is scientist III; Theresa Estep is granulation group leader; and Mark Geis is senior technician at Patheon Pharmaceuticals, 4721 Emperor Blvd., Suite 200, Durham, NC 27703. Tel. 919 226 3200. Webstie: www.patheon.com. Michael Gosselin, formerly of Patheon, is manager, formula- tions at Aptalis. John Dela Cruz is formerly of Patheon. 20 January 2015 Tablets & Capsules Figure 2 Acid resistance of filled capsules after 2 hours in dissolution bath 16% Coating 20% Coating Batch 1 20% Coating Batch 2 20% Coating Batch 3 24% Coating 0% Coating control 100% 80% 60% 40% 20% 0% Enteric coating weight gain Release of acetaminophen after 2 hours in acidic bath (average) 0% 0% 0% 0% 0% 93% Figure 3 Appearance of coated capsules and fill after 2 hours of dissolution testing Start your free subscription at our website. www.tabletscapsules.com www.tabletscapsules.com