In our hospital pharmacy an injectable solution of haloperidol decanoate 141 mg/ml (equivalent to haloperidol 100 mg/ml) in sesame oil was prepared. The aim of this study was to prove bioequivalence of this formulation with the reference product, Haldol Decanoas. 15 schizophrenic patients, already stabilized with Haldol Decanoas, were enrolled. Intramuscular injections were given every three weeks in the following doses: 100 mg (1 x), 200 mg (7 x) and 300 mg (7 x). In this open, randomized, cross-over study all patients received four injections of the reference product, and four injections of the test product. Only after the fourth injection of each product (when steady-state levels were reached) a concentration-time profile of haloperidol was established during the dose interval of 21 days. The pharmacokinetic parameters AUC0-21 and Cmax were statistically evaluated. Based on these parameters the conclusion was drawn that both products were bioequivalent. The preparation of this injectable haloperidol decanoate solution in our hospital pharmacy amounts to an annual saving of approximately $39,000.
Three main symptoms of minimal brain dysfunction (MBD), a common disorder in children, are hyperactivity, learning disabilities, and attention deficits. Drugs like amphetamine and methylphenidate have been demonstrated to produce a significant behavioral improvement in these children. The behavioral response of young rats (3--4 weeks), with selective lesioning of the central dopaminergic system, to a novel environment was analyzed. Both the frequencies and durations of eight mutually exclusive and complementary behavioral categories were scored. By analyzing the behavior in this way it appeared that considerable hyperactivity and learning disabilities could be demonstrated in these rats. Moreover, the bout length of some behavioral categories was somewhat shortened, which might be an indication of deficits in attention. However, treatment of the animals with amphetamine did not produce any "therapeutic" effect on the three symptoms. Since pharmacotherapeutic support is, in our opinion, a "conditio sine qua non" for the validity of the model, we do not believe that the young DA-lesioned rat is an appropriate animal model for MBD.
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