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Titolo:
RELATIVE BIOAVAILABILITY OF ONDANSETRON 8-MG ORAL TABLETS VERSUS 2 EXTEMPORANEOUS 16-MG SUPPOSITORIES - FORMULATION AND GENDER DIFFERENCES
Autore:
JANN MW; ZUMBRUNNEN TL; TENJARLA SN; WARD ES; WEIDLER DJ;
Indirizzi:
MERCER UNIV,SO SCH PHARM,DEPT PHARM PRACTICE,3001 MERCER UNIV DR ATLANTA GA 30341 MERCER UNIV,SO SCH PHARM,DEPT PHARMACEUT SCI ATLANTA GA 30341 MOREHOUSE SCH MED,DEPT FAMILY MED ATLANTA GA 30310 MOREHOUSE SCH MED,DEPT INTERNAL MED ATLANTA GA 30310 MOREHOUSE SCH MED,DEPT PHARMACOL ATLANTA GA 30310
Titolo Testata:
Pharmacotherapy
fascicolo: 2, volume: 18, anno: 1998,
pagine: 288 - 294
SICI:
0277-0008(1998)18:2<288:RBOO8O>2.0.ZU;2-C
Fonte:
ISI
Lingua:
ENG
Soggetto:
CLINICAL PHARMACOKINETICS; PLASMA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
15
Recensione:
Indirizzi per estratti:
Citazione:
M.W. Jann et al., "RELATIVE BIOAVAILABILITY OF ONDANSETRON 8-MG ORAL TABLETS VERSUS 2 EXTEMPORANEOUS 16-MG SUPPOSITORIES - FORMULATION AND GENDER DIFFERENCES", Pharmacotherapy, 18(2), 1998, pp. 288-294

Abstract

Study Objective. To compare the relative bioavailability of two 16-mgextemporaneously prepared suppository formulations with that of an 8-mg commercially available oral tablet. Design. Prospective, crossover bioavailability study. Setting. Inpatient clinical research center. Subjects. Sixteen young, nonsmoking, healthy volunteers. Interventions. Blood samples were obtained 24 and 48 hours after administration of an8-mg oral ondansetron tablet and 16-mg suppository, respectively. Two16-mg suppository formulations were compounded using commercially available Fattibase and Polybase. Measurements and Main Results. Ondansetron was well absorbed by both routes of administration. The following pharmacokinetic parameters (mean +/- SEM) were obtained for the 8-mg tablet, 16-mg Fattibase suppository, and 16-mg Polybase suppository, respectively: area under the curve (AUC) in men 154.2 +/- 21.77, 253.4 +/- 72.3, 304.8 +/- 62.2 ng.hr/ml; AUC in women 353.6 +/- 32.7, 561.6 +/- 103.6, and 768.7 +/- 117.9 ng.hr/ml; maximum concentration (C-max in men 45.5 +/- 7.0, 40.6 +/- 10.4, and 51.2 +/- 6.7 ng/ml; C-max in women 51.4 +/- 4.8, 47.1 +/- 3.9, and 82.9 +/- 6.6 ng/ml. Times to C-max(T-max) mean +/- SEM) for men were 1.5 +/- 0.3, 4.4 +/- 0.5, and 2.9 /- 0.3 hours; T-max for women were 1.8 +/- 0.3, 4.1 +/- 0.4, and 4.4 /- 0.6 hours for the three formulations, respectively. Women had a consistently higher AUC for all three formulations than men (p<0.05). Conclusion. With the exception of the 16-mg Polybase formulation in women, the two suppositories closely approximated the pharmacokinetics of the 8-mg oral tablet. These results suggest that gender may be a significant factor in ondansetron's disposition.

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Documento generato il 29/11/20 alle ore 07:00:41