The evaluation of in-vitro dissolution of mycophenolate mofetil in aqueous buffer media using basket method

The paper presents the evaluation of the in-vitro dissolution profiles of four immediate release oral dosage forms containing mycophenolate mofetil in three aqueous buffer systems. The basket method was adopted and the results were cross-analyzed with the experimental results generated previously in a similar protocol using the paddle apparatus. The influence of the design of the sinkers was also evaluated. The data was analyzed based on pairwise comparison procedures and on calculation of specific dissolution parameters. The results indicated that the conclusions on similarity are dependent on both pH of media and stirring rate. It was confirmed that the acidic media with low pH values are not adequate for routine quality control purposes, because it induced a very rapid and complete release of the drug. The non-sink testing conditions generated by the phosphate buffer pH=6.8 emphasized a considerable impact of the dose solubility ratio.