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Risperidone: effects of formulations on oral bioavailability

R Gutierrez1, P I Lee, M L Huang

  • 1Janssen Research Foundation, Titusville, NJ 08560, USA.

Pharmacotherapy
|May 1, 1997
PubMed
Summary

This study found that the 1-mg oral solution and 1-mg tablet of risperidone are bioequivalent. This means both formulations deliver the same amount of risperidone (and its active metabolite) into the bloodstream.

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Area of Science:

  • Pharmacology
  • Clinical Pharmacy

Background:

  • Risperidone is an atypical antipsychotic used to treat schizophrenia and bipolar disorder.
  • Ensuring bioequivalence between different dosage forms is crucial for therapeutic efficacy and patient safety.

Purpose of the Study:

  • To compare the bioavailability of a 1-mg risperidone oral solution versus a 1-mg risperidone tablet.
  • To determine if the two formulations are bioequivalent.

Main Methods:

  • An open-label, randomized, two-way, crossover study was conducted.
  • Twenty-six healthy male subjects received a single 1-mg dose of each formulation with a 10-day washout period.
  • Plasma concentrations of risperidone and 9-hydroxyrisperidone were measured using radioimmunoassays.

Main Results:

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  • Pharmacokinetic parameters, including Cmax and AUC, were analyzed.
  • The 90% confidence intervals for relative bioequivalence of risperidone, 9-hydroxyrisperidone, and the active moiety fell within the 80-125% range.
  • Log-transformed data also confirmed bioequivalence within the specified range.

Conclusions:

  • The 1-mg/ml oral solution and the 1-mg tablet of risperidone are bioequivalent.
  • This suggests interchangeable use of both formulations for therapeutic purposes.
  • The study supports the use of the oral solution as an alternative to the tablet form.