An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations

Thomas R Walters,1 Robert J Smyth-Medina,2 Paul C Cockrum31Keystone Research, Austin, TX, 2University of California, Los Angeles, CA, 3Health Kinetics, Fort Worth, TX, USAPurpose: The purpose of this study was to quantify the concentration of bromfenac in the aqueous humor utilizing high-performance...

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Autores principales:	Walters TR, Smyth-Medina RJ, Cockrum PC
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Pharmacokinetics PK ocular NSAID aqueous humor Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/4f1a6f621d244a82bd07e4d288573393
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spelling	oai:doaj.org-article:4f1a6f621d244a82bd07e4d2885733932021-12-02T00:40:27ZAn ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations1177-5483https://doaj.org/article/4f1a6f621d244a82bd07e4d2885733932018-05-01T00:00:00Zhttps://www.dovepress.com/an-ex-vivo-human-aqueous-humor-concentration-comparison-of-two-commerc-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Thomas R Walters,1 Robert J Smyth-Medina,2 Paul C Cockrum31Keystone Research, Austin, TX, 2University of California, Los Angeles, CA, 3Health Kinetics, Fort Worth, TX, USAPurpose: The purpose of this study was to quantify the concentration of bromfenac in the aqueous humor utilizing high-performance liquid chromatography mass spectrometry between two commercial nonsteroidal anti-inflammatory drugs, using aqueous humor concentrations to characterize pharmacokinetic proportional differences between 0.075% bromfenac ophthalmic solution in DuraSite (BromSite®) and 0.09% bromfenac ophthalmic solution (Bromday®).Methods: In this multicenter, randomized, double-masked, two-arm, parallel-group, comparative, Phase II clinical trial, subjects were assigned to receive bromfenac in DuraSite or bromfenac ophthalmic solution in a 1:1 ratio. One drop of the masked test article was instilled into the study eye once a day for 2 days prior to and 3 hours prior (last instillation) to the subject’s cataract surgery. Aqueous humor samples were collected upon initial cataract incision for analysis of bromfenac levels. The primary end point was aqueous humor concentration of bromfenac at Day 3, at the initiation of cataract surgery. Aqueous humor samples were collected and analyzed for bromfenac levels.Results: A total of 60 subjects completed the study, 30 in each group. The mean bromfenac aqueous humor concentration in subjects who received bromfenac in DuraSite was more than twice (49.33±41.87 ng/mL, P=0.004) that of subjects who received bromfenac ophthalmic solution (23.65±16.31 ng/mL) after three doses.Conclusion: Mean bromfenac aqueous humor concentration in subjects receiving the DuraSite-containing bromfenac in DuraSite (0.075%) was significantly higher compared to subjects receiving bromfenac ophthalmic solution (0.09%) after 3 days of dosing.Keywords: pharmacokinetics, PK, ocular, NSAID, aqueous humorWalters TRSmyth-Medina RJCockrum PCDove Medical PressarticlePharmacokineticsPKocularNSAIDaqueous humorOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 943-947 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Pharmacokinetics PK ocular NSAID aqueous humor Ophthalmology RE1-994
spellingShingle	Pharmacokinetics PK ocular NSAID aqueous humor Ophthalmology RE1-994 Walters TR Smyth-Medina RJ Cockrum PC An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
description	Thomas R Walters,1 Robert J Smyth-Medina,2 Paul C Cockrum31Keystone Research, Austin, TX, 2University of California, Los Angeles, CA, 3Health Kinetics, Fort Worth, TX, USAPurpose: The purpose of this study was to quantify the concentration of bromfenac in the aqueous humor utilizing high-performance liquid chromatography mass spectrometry between two commercial nonsteroidal anti-inflammatory drugs, using aqueous humor concentrations to characterize pharmacokinetic proportional differences between 0.075% bromfenac ophthalmic solution in DuraSite (BromSite®) and 0.09% bromfenac ophthalmic solution (Bromday®).Methods: In this multicenter, randomized, double-masked, two-arm, parallel-group, comparative, Phase II clinical trial, subjects were assigned to receive bromfenac in DuraSite or bromfenac ophthalmic solution in a 1:1 ratio. One drop of the masked test article was instilled into the study eye once a day for 2 days prior to and 3 hours prior (last instillation) to the subject’s cataract surgery. Aqueous humor samples were collected upon initial cataract incision for analysis of bromfenac levels. The primary end point was aqueous humor concentration of bromfenac at Day 3, at the initiation of cataract surgery. Aqueous humor samples were collected and analyzed for bromfenac levels.Results: A total of 60 subjects completed the study, 30 in each group. The mean bromfenac aqueous humor concentration in subjects who received bromfenac in DuraSite was more than twice (49.33±41.87 ng/mL, P=0.004) that of subjects who received bromfenac ophthalmic solution (23.65±16.31 ng/mL) after three doses.Conclusion: Mean bromfenac aqueous humor concentration in subjects receiving the DuraSite-containing bromfenac in DuraSite (0.075%) was significantly higher compared to subjects receiving bromfenac ophthalmic solution (0.09%) after 3 days of dosing.Keywords: pharmacokinetics, PK, ocular, NSAID, aqueous humor
format	article
author	Walters TR Smyth-Medina RJ Cockrum PC
author_facet	Walters TR Smyth-Medina RJ Cockrum PC
author_sort	Walters TR
title	An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
title_short	An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
title_full	An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
title_fullStr	An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
title_full_unstemmed	An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
title_sort	ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/4f1a6f621d244a82bd07e4d288573393
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An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations

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