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Comparative bioavailability of two risperidone orodispersible tablet products after single dose administration
W Tassaneeyakul1, S Kumar, D Gaysonsiri
1Department of Pharmacology, Khon Kaen University, Thailand. wichitt@kku.ac.th
International Journal of Clinical Pharmacology and Therapeutics
|September 24, 2010
Summary
This study found that the risperidone mouth-dissolving tablet is bioequivalent to the reference product. Both formulations demonstrated comparable bioavailability in healthy male volunteers.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Bioavailability Studies
Background:
- Risperidone is an atypical antipsychotic used to treat schizophrenia and bipolar disorder.
- Orodispersible tablets offer an alternative administration route for improved patient compliance.
- Assessing the bioavailability of generic formulations is crucial for therapeutic equivalence.
Purpose of the Study:
- To evaluate and compare the bioavailability of a test risperidone orodispersible tablet (Ranbaxy) against a reference product (Risperdal Quicklet).
- To determine bioequivalence between the two risperidone formulations in healthy male volunteers under fasting conditions.
Main Methods:
- A randomized, 2-treatment, 2-period, 2-sequence crossover study was performed in 24 healthy Thai male volunteers.
- Plasma concentrations of risperidone and its active metabolite, 9-hydroxyrisperidone, were measured using LC-MS-MS.
- Pharmacokinetic parameters were analyzed using a non-compartmental model.
Main Results:
- The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-t, and AUC0-inf for risperidone were within the 80%-125% bioequivalence range.
- Similar results were observed for the pharmacokinetic parameters of 9-hydroxyrisperidone, with 90% CIs for geometric mean ratios ranging from 96.97% to 97.49%.
Conclusions:
- The test risperidone orodispersible tablet is bioequivalent to the reference product, Risperdal Quicklet.
- The study supports the therapeutic equivalence of the generic risperidone formulation based on US-FDA bioequivalence criteria.
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