Development and evaluation of bio-dissolution systems capable of detecting the food effect on a polysaccharide-based matrix system.

Methods are proposed and tested for mimicking the in vitro food effect on controlled release dosage forms, using USP dissolution apparatus 3. Using in vivo data a pH and time profile was constructed, and the methods utilized either presoaking in peanut oil or continuous oil contact to mimic the presence of a high fat meal. A water soluble drug (propranolol hydrochloride, class 1 by BCS) was used as a model material. Both methods were able to confirm that a labile multiparticulate system (Inderal LA) was susceptible to such in vitro effects. A hydrocolloid matrix tablet showed low susceptibility to either technique. There was a good correlation between methods, which may indicate that the oil presoaking method, which is less time consuming to carry out and leads to more simple subsequent analysis, may be sufficient to identify dosage forms susceptible to physical food effects.