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Titolo:
COMPARATIVE BIOAVAILABILITY STUDY OF 2 HALOPERIDOL DECANOATE CONTAINING PRODUCTS
Autore:
VANWERINGH G; KOMEN BJ; THIEME RE; VANDERHOEVEN RTM; VOS T;
Indirizzi:
ANDREAS HOSP,DEPT PHARM,THEOPHILE BOCKSTR 8 1058 NR AMSTERDAM NETHERLANDS HAARLEM HOSP HAARLEM NETHERLANDS PSYCHIAT HOSP AMSTERDAM,PZA CENTRUM OUD W NOORD 1083 HJ AMSTERDAM NETHERLANDS
Titolo Testata:
Pharmacy world & science
fascicolo: 6, volume: 16, anno: 1994,
pagine: 243 - 247
SICI:
0928-1231(1994)16:6<243:CBSO2H>2.0.ZU;2-E
Fonte:
ISI
Lingua:
ENG
Soggetto:
SCHIZOPHRENIC-PATIENTS; PHARMACOKINETICS; TRIALS; BIOEQUIVALENCE; EQUIVALENCE;
Keywords:
BIOLOGICAL AVAILABILITY; DELAYED-ACTION PREPARATIONS; HALOPERIDOL; HALOPERIDOL DECANOATE; PHARMACOKINETICS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
20
Recensione:
Indirizzi per estratti:
Citazione:
G. Vanweringh et al., "COMPARATIVE BIOAVAILABILITY STUDY OF 2 HALOPERIDOL DECANOATE CONTAINING PRODUCTS", Pharmacy world & science, 16(6), 1994, pp. 243-247

Abstract

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(R). 15-schizophrenic patients, already stabilized with Haldol Decanoas(R), were enrolled. Intramuscular injections were given every three weeks in the following doses: 100 mg (1 x), 200 mg (7 x) and 300 mg (7 x). In this open,randomized, cross-over study all patients received four injections ofthe reference product, and four injections of the test product. Only after the fourth injection oi 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 parametersAUC(0-21) and C-max were statistically valuated. 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.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/05/20 alle ore 22:29:25