Evaluation of Dietary Softgel Capsules using USP<701> and USP<2040>: A Comparative Disintegration Study
Objectives: USP implemented a new rupture disintegration test (USP) for dietary supplements in 2007. This study evaluates a vitamin product using the conventional USP and the new USP rupture test.
Method: The softgel capsules were subjected to accelerated stability conditions (40°C/75% RH) for two and four weeks. The samples were evaluated for disintegration and rupture test according to USP and USP respectively (n=6 each). Gelatin dissolution was also monitored for these samples during the rupture test (n=6 each—extended to 60 min). For gelatin release, the disintegration medium was sampled at 5, 15, 30, 45 and 60 minutes and analyzed at 220 nm by UV-visible spectrophotometer.
Results: All samples (initial, two and four week) passed the USP disintegration test. However, only time zero softgel capsules passed the USP rupture test. Complete gelatin dissolution was observed at 60 minutes; 98.96 ± 2.14%, 95.71 ± 3.14% and 103.53 ± 5.64% for initial, two and four week stability samples, respectively. Statistical analysis (ANOVA) of the gelatin release data showed no significant difference between the 60-minute samples (p > 0.05).
Implications: The gelatin dissolution profile confirms no dissolution differences between fresh and aged product. There are differences in performance between USP and USP. These methods are not equivalent. It is recommended to utilize USP until data is generated to understand if test failures are indicative of non-performing product. Since gelatin dissolution is at the same rate, it is likely the contents would be available for absorption and test method is suitable.
Yacobucci, Matthew; Shan, Chintan; Huang, Ted; Stein, Daniel; Zhao, Fang; and Chablani, Lipika, "Evaluation of Dietary Softgel Capsules using USP<701> and USP<2040>: A Comparative Disintegration Study" (2014). Pharmacy Faculty/Staff Publications. Paper 218.
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