The effect of cross-linking on the in vivo disintegration of hard gelatin capsules

Purpose. To evaluate if the cross-linking of gelatin affects in viva capsule disintegration. Methods. Scintigraphic investigation in nine healthy volunteers to provide for a real time visualisation of capsule disintegration. Results. The moderately stressed capsules failed the USP dissolution specification for acetaminophen capsule when tested in water and conventional SGF bur passed with the addition of pepsin. Moderately stressed capsules started to disintegrate at 10 +/- 6 minutes (range 6 to 24 minutes) compared to 8 +/- 2 minutes (range 5 to II minutes) for the unstressed capsule. Conclusions. The results of the study clearly demonstrate that with the incisive technique of gamma scintigraphy there are no differences in the in viva disintegration properties of moderately stressed and unstressed capsules.