The influence of averaging procedure on the accuracy of IVIVC predictions: immediate release dosage form case study.
In vivo-in vitro correlation (IVIVC) is an effective tool to predict absorption behavior of active substances from pharmaceutical dosage forms. The model for immediate release dosage form containing amoxicillin was used in the presented study to check if the calculation method of absorption profiles can influence final results achieved. The comparison showed that an averaging of individual absorption profiles performed by Wagner-Nelson (WN) conversion method can lead to lose the discrimination properties of the model. The approach considering individual plasma concentration versus time profiles enabled to average absorption profiles prior WN conversion. In turn, that enabled to find differences between dispersible tablets and capsules. It was concluded that in the case of immediate release dosage form, the decision to use averaging method should be based on an individual situation; however, it seems that the influence of such a procedure on the discrimination properties of the model is then more significant.
Ostrowski
Michalł
M
R&D Departament, Polfa Tarchomin SA, Fleminga 2, 03-176 Warszawa, Poland.
Wilkowska
Ewa
E
Baczek
Tomasz
T
D000042:Absorption; D000284:Administration, Oral; D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D005260:Female; D005544:Forecasting; D006801:Humans; D007700:Kinetics; D008297:Male; D008433:Mathematics; D008657:Metabolic Clearance Rate; D012995:Solubility; D013607:Tablets; D013997:Time Factors
D000900:Anti-Bacterial Agents; D002214:Capsules; D004304:Dosage Forms; D013607:Tablets; D000658:Amoxicillin