Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%

William Stringer1, Roy Bryant21Module 3 Pharma Services, St. Petersburg, Florida; 2Encompass Pharmaceutical Services, Norcross, Georgia, USAPurpose: To compare the dose uniformity of difluprednate ophthalmic emulsion 0.05% (Durezol&reg;) with both branded and generic prednisolone acetate oph...

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Autores principales:	William Stringer, Roy Bryant
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2010
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/8b37c7a0aa594e8e87db1d64a3326f62
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spelling	oai:doaj.org-article:8b37c7a0aa594e8e87db1d64a3326f622021-12-02T07:08:42ZDose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%1177-54671177-5483https://doaj.org/article/8b37c7a0aa594e8e87db1d64a3326f622010-09-01T00:00:00Zhttp://www.dovepress.com/dose-uniformity-of-topical-corticosteroid-preparations-difluprednate-o-a5379https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483William Stringer1, Roy Bryant21Module 3 Pharma Services, St. Petersburg, Florida; 2Encompass Pharmaceutical Services, Norcross, Georgia, USAPurpose: To compare the dose uniformity of difluprednate ophthalmic emulsion 0.05% (Durezol&reg;) with both branded and generic prednisolone acetate ophthalmic suspension 1% under different simulated patient usage conditions.Methods: Drug concentrations of difluprednate emulsion, branded prednisolone acetate suspension (Pred Forte&reg;) and generic prednisolone acetate suspension following three storage conditions (upright, then shaken; upright, not shaken; inverted, not shaken) were analyzed by high performance liquid chromatography assay and results were reported as percent of declared concentration. Two drops were dispensed every four hours four times daily.Results: Regardless of bottle orientation and shaking, all difluprednate emulsion concentrations at each time point analyzed were within 15% of declared concentration. Both branded and generic prednisolone acetate suspension concentrations varied substantially throughout the study. For the bottle stored upright and not shaken, 46% of the branded concentrations were not within 15% of declared concentration; for the bottle stored upright and shaken prior to use, 60% failed to meet this criterion. None of the branded concentrations from the inverted and not shaken bottle was within 15% of declared concentration. Generic prednisolone concentrations demonstrated the poorest dose uniformity, with 96% of the concentrations from the inverted and not shaken bottle not within 15% of declared concentration; 94% of the concentrations from the upright and shaken bottle and 87% from the upright and not shaken bottle similarly failed to meet this criterion.Conclusions: Dose uniformity of Durezol emulsion was predictable in all simulated patient usage conditions, whereas the drop concentrations of Pred Forte and generic prednisolone acetate suspensions were highly variable throughout the study. Drop concentrations are more predictable with Durezol emulsion than with either prednisolone acetate suspension.Keywords: difluprednate, dose uniformity, emulsion, prednisolone acetate William StringerRoy BryantDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2010, Iss default, Pp 1119-1124 (2010)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 William Stringer Roy Bryant Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%
description	William Stringer1, Roy Bryant21Module 3 Pharma Services, St. Petersburg, Florida; 2Encompass Pharmaceutical Services, Norcross, Georgia, USAPurpose: To compare the dose uniformity of difluprednate ophthalmic emulsion 0.05% (Durezol&reg;) with both branded and generic prednisolone acetate ophthalmic suspension 1% under different simulated patient usage conditions.Methods: Drug concentrations of difluprednate emulsion, branded prednisolone acetate suspension (Pred Forte&reg;) and generic prednisolone acetate suspension following three storage conditions (upright, then shaken; upright, not shaken; inverted, not shaken) were analyzed by high performance liquid chromatography assay and results were reported as percent of declared concentration. Two drops were dispensed every four hours four times daily.Results: Regardless of bottle orientation and shaking, all difluprednate emulsion concentrations at each time point analyzed were within 15% of declared concentration. Both branded and generic prednisolone acetate suspension concentrations varied substantially throughout the study. For the bottle stored upright and not shaken, 46% of the branded concentrations were not within 15% of declared concentration; for the bottle stored upright and shaken prior to use, 60% failed to meet this criterion. None of the branded concentrations from the inverted and not shaken bottle was within 15% of declared concentration. Generic prednisolone concentrations demonstrated the poorest dose uniformity, with 96% of the concentrations from the inverted and not shaken bottle not within 15% of declared concentration; 94% of the concentrations from the upright and shaken bottle and 87% from the upright and not shaken bottle similarly failed to meet this criterion.Conclusions: Dose uniformity of Durezol emulsion was predictable in all simulated patient usage conditions, whereas the drop concentrations of Pred Forte and generic prednisolone acetate suspensions were highly variable throughout the study. Drop concentrations are more predictable with Durezol emulsion than with either prednisolone acetate suspension.Keywords: difluprednate, dose uniformity, emulsion, prednisolone acetate
format	article
author	William Stringer Roy Bryant
author_facet	William Stringer Roy Bryant
author_sort	William Stringer
title	Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%
title_short	Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%
title_full	Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%
title_fullStr	Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%
title_full_unstemmed	Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%
title_sort	dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%
publisher	Dove Medical Press
publishDate	2010
url	https://doaj.org/article/8b37c7a0aa594e8e87db1d64a3326f62
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Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%

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