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.
1Department of Pharmaceutical Technology and Biopharmaceutics,
2Department of Pharmaceutical Physics and Informatics,
3Department of Drug Industry and Pharmaceutical Biotechnologies.
* corresponding author: dalia_simona_m@yahoo.com
Download Full Article

Abstract:

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.

Top