Development and Validation of Computer Spreadsheet Used to Calculate Dissolution Profiles without Media Replacement

Abstract

Calculations carried out to generate dissolution profile data are complicated and subject to error to be performed manually, moreover and due to the repetitive nature of the dissolution testing experiments it is necessary to create a validated spreadsheet to replace and overcome the problems associated with manual calculations. A simple, user friendly spreadsheet was written to calculate dissolution profiles for a dissolution experiment where the volume of the dissolution medium for the vessel varies with time as the removed dissolution medium is not replaced with fresh one at each time point. The calculations of the spreadsheet were validated against manual calculations using a hand-held calculator; the results of the two methods were found to be comparable. The developed spreadsheet can be easily adapted for use in regulated environment after activating the security features embedded in Microsoft Excel software such as formula hiding, cell block and password protection.