Abstract:
OBJECTIVE To get the data of dissolution curve in Japanese Orange Book or FDA solid oral dosage forms database by using the graph digitizer software. By similarity factor (
f2) calculation, it can forecast consistency evaluation of dissolution curve between domestic generics and original research drug
in vitro.
METHODS According to the software instructions, set the value of the origin and the maximum value of the vertical coordinate and the horizontal coordinate. By screenshot software to obtain the figure of dissolution curve for reference preparation, saved as image files. The point on the dissolution curve was determined, then the cumulative dissolution data of each point could be obtained by software analysis. Calculate the
f2 value using
f2 similar factor calculation formula. The consistency of dissolution curve between generic drugs and reference preparation could be forecasted.
RESULTS Through graph digitizer software to get dissolution data in Japanese orange book or FDA solid oral dosage forms database. Evaluate consistency of the dissolution curve
in vitro between generic drugs and reference formulations.
CONCLUSION The graph digitizer software can be used for data processing to get the dissolution curve data of the reference preparation in the literature, and it can be used to evaluate the consistency of the dissolution curve
in vitro for generic drugs.