THE IN VITRO RELEASE PROFILES OF
NIMESULIDE FROM ORAL SOLID DOSAGE
FORMS, IN COMPENDIAL AND MODIFIED
PHYSIOLOGICAL MEDIA.
FLAVIAN ȘTEFAN RĂDULESCU1, ION-BOGDAN DUMITRESCU2,
DALIA SIMONA MIRON2*, DUMITRU LUPULEASA3, ADRIAN
ANDRIEȘ1, DOINA DRĂGĂNESCU2
1University of Medicine and Pharmacy „Carol Davila” Bucharest,
Faculty of Pharmacy, Department of Pharmaceutical Industry, 6 Traian
Vuia street, 020956, Bucharest, Romania
2University of Medicine and Pharmacy „Carol Davila” Bucharest,
Faculty of Pharmacy, Department of Pharmaceutical Physics, 6 Traian
Vuia street, 020956, Bucharest, Romania
3University of Medicine and Pharmacy „Carol Davila” Bucharest,
Faculty of Pharmacy, Department of Pharmaceutical Technology, 6
Traian Vuia street, 020956, Bucharest, Romania
*corresponding author: dalia_simona_m@yahoo.com
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Abstract:

Nimesulide is a typical Biopharmaceutical Classification System class II drug, frequently imposing the presence of high amount of tensioactive substances combined with non-physiological pH values for complete dissolution during the in vitro release profiling.
Thus, the risk of erroneous estimation for the biopharmaceutical performance of a specific drug product is increased by these non-discriminatory conditions, with further implication on the safety and efficacy profile of the active ingredient. The current paper presents the influence of several characteristics of currently recommended compendial or physiological simulated media on the in vitro dissolution pattern for nimesulid, underlying their importance and biological relevance.

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