Premium
Comparison of the Stability, Efficacy, and Adverse Effect Profile of the Innovator 0.005% Latanoprost Ophthalmic Solution and a Novel Cyclodextrin‐containing Formulation
Author(s) -
Gonzalez Jaime R.,
BaizaDuran Leopoldo,
QuintanaHau Juan,
TorneroMontaño Ruben,
CastanedaHernandez Gilberto,
Ortiz Mario,
AlarconOceguera Felipe,
BeltranLoustaunau Marco,
CortezGastelum Marco,
GarcidueñasMejia Jorge,
GomezBastar Pedro,
JimenezRoman Jesus,
KorderOrtega Vincent,
PaczkaZapata Jose,
TorresSegura Marina,
VelascoGallegos Gustavo
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006292626
Subject(s) - latanoprost , innovator , medicine , adverse effect , cyclodextrin , intraocular pressure , glaucoma , clinical efficacy , ophthalmology , anesthesia , pharmacology , chromatography , surgery , chemistry , computer science , intellectual property , operating system
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°C but exhibited degradation at higher temperatures, whereas the cyclodextrin‐containing formulation was stable at temperatures up to 40°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.