Romanian Society of Pharmaceutical Sciences
 

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THE IMPACT OF DIFFERENCES BETWEEN REGULATORY GUIDANCE FOR IN VITRO TESTING ON THE DISSOLUTION PROFILES OF MYCOPHENOLATE MOFETIL

NAHLA NUMAN AQEL1, DUMITRU LUPULEASA1, MIRELA ADRIANA MITU1, ANA ANDREEA STĂNESCU1, CĂTĂLIN DONEA1, DALIA SIMONA MIRON2*, FLAVIAN ȘTEFAN RĂDULESCU3

University of Medicine and Pharmacy „Carol Davila” Bucharest, Faculty of Pharmacy, 6th Traian Vuia street, 020956, Bucharest, Romania.
1.Department of Pharmaceutical Technology and Biopharmaceutics,
2.Department of Pharmaceutical Physics and Informatics,
3.Department of Drug Industry and Pharmaceutical Biotechnologies.

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The paper presents the results of in vitro dissolution testing for various immediate release solid oral dosage forms (three film coated tablets and one capsule formulations), containing 250 and 500 mg mycophenolate mofetil. The release profiles were evaluated according to the current recommendations available in the international biowaiver guidance, including three pH stages and two stirring rates. A very rapid and complete release was observed in the acidic conditions. The most discriminatory conditions were obtained when the acetate buffer pH=4.5 was used as release media. The low solubility of the drug substance pointed out the methodological limitation in non-sink conditions; mostly concerning the comparison of different dose strength.