Disintegration and Rupture Testing of Omega-3 Soft Capsules

Abstract

Omega-3 fatty acid soft capsules are a popular nutritional supplement. Previous product quality studies reported in the literature have mostly only addressed specifications for omega-3 fatty acid content and chemical stability aspects. This study aimed to characterize the in vitro release characteristics of omega-3 from soft capsules in aqueous media using disintegration and rupture tests. Four gelatin and one non-gelatin (starch/carrageen) commercially available omega-3 soft capsule products were evaluated using water and 0.1 N HCl as the media. In general, most products displayed faster release in the acidic medium compared to water. There was a statistically significant correlation between the disintegration and rupture test times. Although between-product disintegration and rupture test times varied considerably, all products ruptured within 15 minutes and completely disintegrated within 30 minutes in both media.