8. Dissolution studies
Assessment of dissolution of chemicals and pharmaceutical formulations is conducted in a standardized shortâterm assay. In contrast with the simplified dissolution experiments typically performed in pharmaceutical industry, the ProDigest assay allows to work under highly representative intestinal conditions. This results in a dramatically increased predictive value of the obtained dissolution profiles. The ProDigest dissolution experiment can be performed under both fasted and fed conditions and consists of the sequential incubation of a representative dose of the selected products under simulated conditions (either fasted or fed) for:
- Stomach (low pH, pepsin);
- Small intestine (high pH, addition of pancreatic enzymes and bile salts).
This approach is typically used to evaluate the intestinal passage of capsules and pharmaceutical formulations for targeted release of active compounds and makes use of a temperature-controlled continuously stirred reactor in which the capsules are fixed in the reactor using a sinker device. The reactors can be sampled at different time intervals and specific analyses can be conducted to evaluate the dissolution/bioavailability of the active compounds from a formulation or the survival of probiotics under intestinal conditions.