Dissolution, bioavailability and pharmacokinetics of three nitrofuratoin preparations in man
Bron, J.; Vree, T.B.; Damsma, J.E.; Hekster, Y.A.; van der Kleijn, E.
Arzneimittel-Forschung 29(10): 1614-1620
1979
ISSN/ISBN: 0004-4172 PMID: 42416 Document Number: 3639
In a series of in vitro and in vivo experiments, the dissolution, bioavailability and pharmacokinetics of three commercial nitrofurantoin preparations, formulation A, formulation B and Ceduran®, were studied and compared. Plasma and urine levels were determined using a HPLC method recently described by the same authors. From the in vivo results it is concluded that nitrofurantoin formulation B is significantly less absorbed and excreted than the two other preparations, thus, depending on the minimum inhibitory concentration for the bacteria resulting in reduced possibilities to eradicate urinary tract infections. Nitrofurantoin formulation A and Ceduran are bioequivalent, but in view of the reduction of side effects Ceduran seems to be the drug of choice. An in vitro dissolution test for nitrofurantoin, carried out using the USP XIX disintegration apparatus, provided profiles comparable to the in vivo results and thus seemed reliable for batch-to-batch control of nitrofurantoin preparations.
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