Comparative bioavailability of two oral formulations of ketorolac tromethamine: Dolac® and Exodol®

Francisco J. Flores‐Murrieta; Vinicio Granados‐Soto; Gilberto Castañeda‐Hernández; Jorge E. Herrera; Enrique Hong

doi:10.1002/bdd.2510150205

Comparative bioavailability of two oral formulations of ketorolac tromethamine: Dolac^® and Exodol^®

Francisco J. Flores‐Murrieta, Vinicio Granados‐Soto, Gilberto Castañeda‐Hernández, Jorge E. Herrera, Enrique Hong

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

The bioavailability of ketorolac after administration of two oral formulations containing 10 mg of ketorolac tromethamine, Exodol^® and Dolac^®, to 12 healthy Mexican volunteers was compared. Subjects received both formulations according to a randomized crossover design and blood samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma‐concentration‐against‐time curves were constructed. Maximal plasma concentration and AUC_0‐24. values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged from 80 to 125% for C_max and from 85 to 118% for AUC_0‐24. It is concluded that the two assayed formulations are bioequivalent.

Original language	English
Pages (from-to)	129-136
Number of pages	8
Journal	Biopharmaceutics and Drug Disposition
Volume	15
Issue number	2
DOIs	https://doi.org/10.1002/bdd.2510150205
State	Published - Mar 1994
Externally published	Yes

Keywords

Bioequivalence
Ketorolac tromethamine

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10.1002/bdd.2510150205

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title = "Comparative bioavailability of two oral formulations of ketorolac tromethamine: Dolac{\textregistered} and Exodol{\textregistered}",

abstract = "The bioavailability of ketorolac after administration of two oral formulations containing 10 mg of ketorolac tromethamine, Exodol{\textregistered} and Dolac{\textregistered}, to 12 healthy Mexican volunteers was compared. Subjects received both formulations according to a randomized crossover design and blood samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma‐concentration‐against‐time curves were constructed. Maximal plasma concentration and AUC0‐24. values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged from 80 to 125% for Cmax and from 85 to 118% for AUC0‐24. It is concluded that the two assayed formulations are bioequivalent.",

keywords = "Bioequivalence, Ketorolac tromethamine",

author = "Flores‐Murrieta, {Francisco J.} and Vinicio Granados‐Soto and Gilberto Casta{\~n}eda‐Hern{\'a}ndez and Herrera, {Jorge E.} and Enrique Hong",

year = "1994",

month = mar,

doi = "10.1002/bdd.2510150205",

language = "Ingl{\'e}s",

volume = "15",

pages = "129--136",

journal = "Biopharmaceutics and Drug Disposition",

issn = "0142-2782",

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TY - JOUR

T1 - Comparative bioavailability of two oral formulations of ketorolac tromethamine

T2 - Dolac® and Exodol®

AU - Flores‐Murrieta, Francisco J.

AU - Granados‐Soto, Vinicio

AU - Castañeda‐Hernández, Gilberto

AU - Herrera, Jorge E.

AU - Hong, Enrique

PY - 1994/3

Y1 - 1994/3

N2 - The bioavailability of ketorolac after administration of two oral formulations containing 10 mg of ketorolac tromethamine, Exodol® and Dolac®, to 12 healthy Mexican volunteers was compared. Subjects received both formulations according to a randomized crossover design and blood samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma‐concentration‐against‐time curves were constructed. Maximal plasma concentration and AUC0‐24. values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged from 80 to 125% for Cmax and from 85 to 118% for AUC0‐24. It is concluded that the two assayed formulations are bioequivalent.

AB - The bioavailability of ketorolac after administration of two oral formulations containing 10 mg of ketorolac tromethamine, Exodol® and Dolac®, to 12 healthy Mexican volunteers was compared. Subjects received both formulations according to a randomized crossover design and blood samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma‐concentration‐against‐time curves were constructed. Maximal plasma concentration and AUC0‐24. values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged from 80 to 125% for Cmax and from 85 to 118% for AUC0‐24. It is concluded that the two assayed formulations are bioequivalent.

KW - Bioequivalence

KW - Ketorolac tromethamine

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U2 - 10.1002/bdd.2510150205

DO - 10.1002/bdd.2510150205

M3 - Artículo

SN - 0142-2782

VL - 15

SP - 129

EP - 136

JO - Biopharmaceutics and Drug Disposition

JF - Biopharmaceutics and Drug Disposition

IS - 2

ER -

Comparative bioavailability of two oral formulations of ketorolac tromethamine: Dolac^® and Exodol^®

Abstract

Keywords

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