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20 May 2014 Tablets & Capsules Capsules and Capsule Filling Desktop Reference Rupture in SGF indicates that the softgels would not remain intact in the low pH of the stomach and could leave consumers with a fishy aftertaste and burps. This could diminish patient compliance, and thus diminish the health benefits from the fish oil. Two brands of commercially available fish oil softgels coated with our aqueous EC dispersion containing the pH-dependent pore-former were also tested for DR per- formance. Six softgels from each manufacturer were tested in the SGF, similar to the testing conducted on products that used the anti-reflux technology. Each of the six DR coated softgels was weighed prior to disintegra- tion testing. After weighing, all were placed in the SGF for 1 hour, and both brands stayed intact (Figure 2). The softgels were then removed from the SGF, blotted dry, and re-weighed to determine how much acid uptake occurred during testing. The percentage weight gain of the softgels is reported as percentage of acid uptake, and an uptake of less than 10 percent is typically acceptable. In this case, uptake for both sets of softgels was less than 5 percent. After weighing and drying, the softgels were reciprocated in SIF at 37° ±2°C until they ruptured, which took less than 60 minutes. In previously published work [7], we evaluated the sta- bility of fish oil softgels bearing an EC-based coating. The fish oil softgels were coated to a 4 percent theoreti- cal weight gain in a 24-inch-diameter fully perforated, side-vented coating pan and then packaged in 100-cubic- centimeter induction-sealed HPDE bottles and stored in intermediate (30°C/65 percent relative humidity (RH)) conditions for 12 months and accelerated conditions (40°C/75 percent RH) for 6 months. The softgels with the EC-based coating system were assessed for DR per- formance after 0, 3, 6, and 12 months of storage. At each time point, the samples passed DR disintegration testing, remaining completely intact without any sign of cracking or splitting after 1 hour in SGF. All capsules were trans- ferred to SIF and disintegrated completely. The stability of these DR-coated softgels ensures that users will avoid the undesirable aftertaste and burps of fish oil while obtaining the benefit of these supplements. We have also demonstrated the ability to coat softgels with the EC and pH-dependent pore-former system in a continuous coating process [8]. In that work, softgels were coated in a 13.3-foot-long, 24-inch-diameter con- tinuous coating pan. Three trials were done. The theoret- ical weight gain of the EC-based coating applied, as well as the throughput of the softgels, varied in each trial. During all three trials in the continuous coater, samples of the coated softgels were taken every 5 minutes. Each sample was tested for gastric protection in SGF for 1 hour, and each passed DR disintegration testing. T&C References 1. Porter, SC. Coating of Pharmaceutical Dosage Forms. Remington: The Science and Practice of Pharmacy, 20th ed., Lippincott Williams & Wilkins, 897- 898 (2000). 2. Colorcon. Nutrateric Enteric Coating System for Nutritional Supplements http://www.colorcon.com 3. Young, C., Steffenino, R., Farrell, T. Performance Comparison of Two Delayed Release Coating Systems for Dietary Supplements. Poster presented at Controlled Release Society Annual Meeting 2010. 4. Chidambaram, N. Gastric reflux resistant dosage forms. Patent 20070148248 28 (June 2007). 5. USP 35-NF 30, specifications; <2040> Disin - tegration and Dissolution of Dietary Supplements: Delayed Release Tablets. 6. USP 35-NF 30; Reagents; Test Solutions. 7. Koska, Megan C., Vesey, Charles, F., Steffenino, Rita M. ICH Stability of Dietary Supplements Coated with an Aqueous Ethylcellulose Based Delayed Release Coating for Nutritional Applications. Poster presented at American Association of Pharamceutical Scientists Annual Meeting 2010. 8. Cunningham, C., Young C., Nuneviller, F., Hansell, J. Evaluation of a Continuous Coating Process for the Application of a Regulatory Compliant Nutritional Enteric Coating on Soft Gelatin Capsules. Poster pre- sented at Supply Side West Annual Meeting 2008. Laura Scattergood is a principal area technical manager at Colorcon, 420 Moyer Blvd., West Point, PA 19486. Tel. 215 699 7733, fax 215 661 2626. Website: www.colorcon.com. In her 16 years at Colorcon, Scattergood has focused on delayed-, sustained-, and immediate-release coating processes. Figure 2 Softgels coated with an EC dispersion combined with a nutritional enteric component remained intact in SFG for 60 minutes, in accordance with USP 35-NF 30 protocol. www. tabletscapsules .com g-Scatterart_18-21_Nutra 4/30/14 1:43 PM Page 20