Comparison of the stability, efficacy, and adverse effect profile of the innovator 0.005% latanoprost ophthalmic solution and a novel cyclodextrin-containing formulation.

Abstract:

:Recently, a new latanoprost ophthalmic solution containing cyclodextrins was developed. The purpose of the present work was to compare the stability, clinical efficacy, and adverse effect profile of this formulation with the innovator product. The innovator formulation was stable at 4 degrees C but exhibited degradation at higher temperatures, whereas the cyclodextrin-containing formulation was stable at temperatures up to 40 degrees C. Formulations were assayed in a randomized double-blind clinical study in patients with primary open-angle glaucoma and/or ocular hypertension. Both latanoprost ophthalmic solutions produced comparable reduction of intraocular pressure. Conjunctival hyperemia was observed in 11.9% and 11.3% of the patients treated with the innovator and the cyclodextrin-containing formulations, respectively. There were no significant differences between the 2 ophthalmic solutions in efficacy or in the measured adverse effect. It is concluded that these 2 latanoprost ophthalmic solutions yield comparable efficacy and adverse effect outcomes. The cyclodextrin-containing formulation, however, has an improved stability.

journal_name

J Clin Pharmacol

authors

Gonzalez JR,Baiza-Duran L,Quintana-Hau J,Tornero-Montaño R,Castaneda-Hernandez G,Ortiz M,Alarcon-Oceguera F,Beltran-Loustaunau M,Cortez-Gastelum M,Garcidueñas-Mejia J,Gomez-Bastar P,Jimenez-Roman J,Korder-Ortega V,Paczka-Zapata

doi

10.1177/0091270006292626

subject

Has Abstract

pub_date

2007-01-01 00:00:00

pages

121-6

issue

1

eissn

0091-2700

issn

1552-4604

pii

47/1/121

journal_volume

47

pub_type

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