Mathematical methods for quantification and comparison of dissolution testing data.

In recent years, drug release/ dissolution  from solid dosage forms has been the subject of intense and profitable scientific developments. Whenever a new solid dosage form is developed or produced, it is necessary to ensure that drug  dissolution occurs in an appropriate manner. The pharmaceutical industry and the registration authorities do focus, nowadays, on drug  dissolution  studies. The quantitative analysis of the values obtained in  dissolution /release tests is easier when  mathematical formulas that express the  dissolution  results as a function of some of the dosage forms characteristics are used. This work discusses the analysis of  data  obtained for  dissolution  profiles under different media pH conditions using  mathematical methods of analysis described by Moore and Flanner. These authors have described difference factor (f1) and similarity factor (f2), which can be used to characterise drug  dissolution /release profiles. In this work we have used these formulas for evaluation of  dissolution  profiles of the conventional tablets in different pH of  dissolution  medium (range of physiological variations).