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Purpose  When establishing IVIVC, a special problem arises by interpretation of averaged  in vivo  profiles insight of considerable individual variations in term of time and number of mechanical stress events in GI-tract. The objective of the study was to investigate and forecast the effect of mechanical stress on  in vivo  behavior in human of hydrophilic matrix tablets.    Methods  Dissolution profiles for the marketed products were obtained at different conditions (stirring speed, single- or repeatable mechanical stress applied) and convoluted into C-t profiles. Vice versa, published  in vivo  C-t profiles of the products were deconvoluted into absorption profiles and compared with dissolution profiles by similarity factor.    Results  Investigated hydrophilic matrix tablets varied in term of their resistance against hydrodynamic stress or single stress during the dissolution. Different scenarios, including repeatable mechanical stress, were investigated on mostly prone Seroquel® XR 50 mg. None of the particular scenarios fits to the published  in vivo  C-t profile of Seroquel® XR 50 mg representing, however, the average of individual profiles related to scenarios differing by number, frequency and time of contraction stress. When different scenarios were combined in different proportions, the profiles became closer to the original  in vivo  profile including a burst between 4 and 5 h, probably, due to stress-events in GI-tract.    Conclusion  For establishing IVIVC of oral dosage forms susceptible mechanical stress, a comparison of the deconvoluted individual  in vivo  profiles with  in vitro  profiles of different dissolution scenarios can be recommended.

IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress