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Tablets & Capsules Capsules and Capsule Filling Desktop Reference May 2014 19 based solutions. However, shellac has stability limitations that make it a poor choice to mask the taste of fish oil. But other products are available. In 2003, Colorcon launched a delayed-release (DR) coating system for dietary supplements that meets regulatory requirements in North America and Europe and that uses ingredients that are approved as food additives and/or have self- affirmed GRAS status for use in dietary supplements. The coating, called Nutrateric, combines Surelease—an aque- ous ethylcellulose (EC) dispersion—with a nutritional enteric component called NS Enteric. EC is a water-insol- uble pH-independent polymer that forms a non-eroding diffusion barrier, and the enteric additive functions as a pH-dependent pore-former within the EC film to delay release. As a clear formulation, the coating is 85 percent aqueous EC dispersion and 15 percent enteric additive, hydrated to a 10 percent solids concentration. Pigmented versions are also available. This DR coating system is easily prepared. First, the pH-dependent pore-former is dispersed in room-temper- ature de-ionized water under low shear and mixed for 60 to 90 minutes. The aqueous EC dispersion is then added to the solution and mixed slowly for an additional 15 minutes. It is then ready for use, typically at a theoretical weight gain of 3 to 4 percent on softgels using standard coating equipment and standard coating parameters. Another method of delaying the release of softgels is to use an anti-reflux technology. It typically comprises a gastro-resistant natural polymer (such as pectin), a film- forming natural polymer and, optionally, a gelling agent. Anti-reflux technology cross-links the gelatin in the soft- gel, allowing it to remain intact longer after ingestion [4]. Determining how well these two approaches work re - quires testing, and a test method listed in USP 35-NF 30— <2040> Disintegration and Dissolution of Dietary Supplements, Delayed Release Tablets [5]—is well suited to the task. It calls for reciprocating coated softgels (n = 6) for 1 hour in simulated gastric fluid (SGF) at 37° ±2°C. If the softgels remain intact over that period and show no evi- dence of disintegration, cracking, or softening, they are then reciprocated in simulated intestinal fluid (SIF) at 37° ±2°C until rupture. The tests are performed in Apparatus B, which is required for capsules longer than 18 millimeters. The SGF and SIF are prepared in accordance with USP [6]. Comparing performance Commercially available fish oil softgels from three dif- ferent manufacturers that use the anti-reflux technology were tested for disintegration. The label of one product claimed an "all natural enteric" and "no fishy aftertaste." Six softgels of this product were placed in the SGF and failed after 7 minutes (Figure 1a). The label of the second product made similar claims as the first: "all natural enteric" and "no fishy aftertaste." Again, six softgels were tested for DR disintegration in SGF and failed after 30 minutes (Figure 1b). The third product tested failed after 20 minutes (Figure 1c). Figure 1 a. The first brand ruptured after 7 minutes in SGF. b. The second brand ruptured within 30 minutes in SGF. c. The third brand failed after 20 minutes. Disintegration test results of softgels that use anti-reflux technology g-Scatterart_18-21_Nutra 4/30/14 1:43 PM Page 19