Comparative bioavailability study of two haloperidol decanoate containing products
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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 ×), 200 mg (7 ×) and 300 mg (7 ×). 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.
KeywordsBiological availability Delayed-action preparations Haloperidol Haloperidol decanoate Pharmacokinetics
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- 2.Pakes GE. Haloperidol decanoate in perspective. In: Johnson DAW, editor. Haloperidol decanoate and the treatment of chronic schizophrenia. New York: Adis Press, 1982:108–11.Google Scholar
- 3.Reyntjes AJM, Heykants JJP, Woestenborghs RJH, Gelders YG, Aerts TJL. Pharmacokinetics of haloperidol decanoate: a 2-year follow-up. Int Pharmacopsychiat 1982, 17:238–46.Google Scholar
- 5.Suy E, Woestenborghs R, Heykants J. Bioavailability and clinical effect of two different concentrations of haloperidol decanoate. Curr Ther Res 1982;31:982–91.Google Scholar
- 6.Nayak RK, Nair NPV, Doose DR, McCarthy LR, Desiraju RK. Pharmacokinetics of haloperidol and haloperidol decanoate in schizophrenic patients. Clin Pharmacol Ther 1985;37:217.Google Scholar
- 9.American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 3rd ed., revised. Washington: American Psychiatric Press, 1987.Google Scholar
- 10.Bouma P, Uges DRA. De bepaling van enige xenobiotica in lichaamsvloeistoffen. Praktische analysevoorschriften IV. Haloperidol [Methods for the analysis of some xenobiotics in body fluids. Haloperidol]. Ziekenhuisfarmacie 1987;3(4): 147.Google Scholar
- 19.Zuidema J, Pieters FAJM, Duchateau GSMJE. Release and absorption rate aspects of intramuscularly injected pharmaceuticals. Int J Pharm 1988;47:1–12.Google Scholar