Clinical significance of generic inequivalence of three different pharmaceutical preparations of phenytoin.

摘要: The plasma levels of phenytoin (diphenylhydantoin, DPH) in epileptic patients were significantly higher after treatment with either two preparations containing the sodium salt DPH, than same dose free acid. This was confirmed both short and long term studies, latter increased DPH accompanied by better control generalized seizures. degree acute side-effects 6 out 10 whose changed from DPH-acid to DPH-sodium proportional level DPH; varied 22.8 34.9 µg/ml affected patients. After a single oral healthy volunteers, showed much bioavailability differences volunteers probably depended on particle size its excipient, lactose or starch, did not seem affect formulations sodium-DPH.