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Application of in vitro – in vivo correlations (IVIVC) in setting formulation release specifications
Author(s) -
Modi Nishit B.,
Lam Andrew,
Lindemulder Elizabeth,
Wang Bei,
Gupta Suneel K.
Publication year - 2000
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.248
Subject(s) - ivivc , in vivo , computer science , chemistry , pharmacology , medicine , mathematics , dissolution testing , drug , biopharmaceutics classification system , microbiology and biotechnology , biology
An in vitro – in vivo correlation (IVIVC) was established for an osmotic controlled‐release dosage form by deconvolution using data from an immediate‐release treatment as the characteristic response. The established IVIVC was evaluated internally (predicting data used to develop the IVIVC) and externally (predicting data not originally included in developing the IVIVC), and the application of the IVIVC in product development was demonstrated. The estimated in vivo dissolution profile compared favorably with the in vitro drug release profile. Good agreement was demonstrated between the estimated and observed cumulative drug release across the entire time course (level A correlation) with low (<10%) predictive error for both C max and AUC ∞ . External validation using lots not initially included in the model development compared very well with the observed in vivo profile, with mean prediction errors less than 10% for both C max and AUC ∞ . The proposed method demonstrates a schema for developing IVIVCs using data from biostudies routinely conducted during formulation development. The method should facilitate product optimization and can support setting in vitro dissolution specification. Copyright © 2000 John Wiley & Sons, Ltd.