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|The evaluation of in-vitro dissolution of mycophenolate mofetil in aqueous buffer media using basket method
|Aqel N.N., Popescu I.A., Lupuleasa D., Miron D.S., Rădulescu F.Ș.
|University of Medicine and Pharmacy „Carol Davila” Bucharest, Faculty of Pharmacy, no.6 Traian Vuia St., 020956, Bucharest, Romania.
1Department of Pharmaceutical Technology and Biopharmaceutics,
2Department of Pharmaceutical Physics and Informatics,
3Department of Drug Industry and Pharmaceutical Biotechnologies.
|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.
|mycophenolate mofetil, in-vitro dissolution, USP apparatus 1, Japanese sinkers.
|Ioana Andreea Popescu, University of Medicine and Pharmacy „Carol Davila” Bucharest, Faculty of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, no.6 Traian Vuia St., 020956, Bucharest, Romania, Tel. +40-(21)-3180740, email: email@example.com.