DG DISPATCH - APA: Intramuscular Formulation Stabilizes Risperidone Plasma Levels
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DG DISPATCH - APA: Intramuscular Formulation Stabilizes Risperidone Plasma Levels

By Lara Pullen
Special to DG News

CHICAGO, IL -- May 19, 2000 -- Administration of risperidone via an intramuscular (IM) depot resulted in equivalent daily body exposure of the active moiety when compared to oral risperidone.

At the 2000 Annual Meeting of the American Psychiatric Association, Marielle Eerdekens, MD, of Janssen Pharmaceutica, Belgium, presented the results of a 15-week study of IM risperidone in schizophrenic patients.

The 86 patients in the study were aged 18-65 and physically healthy, with a Diagnostic and Statistical Manual (DSM)-IV diagnosis of chronic stable schizophrenia.

They had received oral risperidone at doses of 2, 4, or 6 mg/day for at least one month before the trial started and were clinically stable. Starting at week two and every two weeks thereafter, the patients were switched from oral to IM risperidone and received a total of 5 IM depot injections of 25, 50, or 75 mg risperidone.

After dosing, the median steady-state plasma levels of the active moiety was 11.1 to 32.8 ng/ml at the lowest dose, 18.1 to 67.2 ng/ml at the medium dose, and 29.1 to 101.0 ng/ml at the highest dose.

Clinical symptoms were stable or improved in all three groups when treatment was changed from oral to depot dosing.

The effect of the decreased fluctuations in plasma levels of risperidone seen with the depot formulation is not yet clear. Dr. Eerdekens explains, "What everybody seems to agree is that the lower the fluctuations, the better it is… But this is still a hypothesis that remains to be proven."

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