• 생물정신의학
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• 제14권2호
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• pp.99-105
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• 2007

Objectives : The purpose of present study was to investigate the effect, safety and tolerability of risperdal sachet(oral solution) with lorazepam tablet versus intramuscular haloperidol and lorazepam injection for management of acute psychotic symptom in the elderly with organic mental disorder. Methods : Total 37 patients who have dementia, medical or physical diseases, associated with acute psychotic symptom were randomly assigned to oral treatment with 1mg of risperdal sachet(oral solution) plus 1mg of lorazepam(N=17) or to intramuscular treatment with 2.5mg of haloperidol plus 2mg of lorazepam (N=20). The change of CGI scores was used for the evaluation of efficacy. Results : Mean score improvements at 15, 30, 60, and 120 minutes after treatment were statistically significant at each time point in both groups(p<0.001) and were similar in both groups(p=0.189). Conclusion : A single oral dose of risperdal sachet(oral solution) plus lorazepam was as effective and tolerable as parenterally administered haloperidol plus lorazepam for the rapid control of acute psychotic symptom in the elderly with organic mental disorder.

• Journal of Pharmaceutical Investigation
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• 제34권2호
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• pp.139-145
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd.) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperidone release from the two risperidone formulations in vitro was tested using KP VIII Apparatus II method with various of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33\;{\pm}2.10$ years in age and $69.24{\pm}8.05\;kg$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross over study was employed. After one tablet containing 2 mg as risperidone was orally administered, blood was taken at predetermined time intervals and the concentrations of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$,$C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the analysis of the parameters using logarithmically transformed $AUC_t$,$C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Risperdal were 0.20, -1.29 and -11-09% for $AUC_t$,$C_{max},\;and\;T_{max}$, respectively There were no sequence effects two formulations in parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,$log(0.90){\sim}log(1.30)$ and $log(0.84){\sim}log(1.09)$ for$AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.