DDSolver: an add-in program for modeling and comparison of drug dissolution profiles

Abstract

In recent years, several mathematical models have been developed for analysis of drug dissolution data, and many different mathematical approaches have been proposed to assess the similarity between two drug dissolution profiles. However, until now, no computer program has been reported for simplifying the calculations involved in the modeling and comparison of dissolution profiles. The purposes of this article are: (1) to describe the development of a software program, called DDSolver, for facilitating the assessment of similarity between drug dissolution data; (2) to establish a model library for fitting dissolution data using a nonlinear optimization method; and (3) to provide a brief review of available approaches for comparing drug dissolution profiles. DDSolver is a freely available program which is capable of performing most existing techniques for comparing drug release data, including exploratory data analysis, univariate ANOVA, ratio test procedures, the difference factor f (1), the similarity factor f (2), the Rescigno indices, the 90% confidence interval (CI) of difference method, the multivariate statistical distance method, the model-dependent method, the bootstrap f (2) method, and Chow and Ki's time series method. Sample runs of the program demonstrated that the results were satisfactory, and DDSolver could be served as a useful tool for dissolution data analysis.

Fig. 1

Interface of the DDSolver program. After the program is installed, a pull-down menu will appear in the menu bar when Excel is launched

Fig. 2

Interface of the DDSolver program. Dissolution data can be entered by drag-selecting the corresponding range of cells in the spreadsheet

Fig. 3

Sample sheet showing the use of predefined dissolution functions; the names of the functions are listed in Column G, while Column F shows the calculation results