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A comparative study of a preservative-free latanoprost cationic emulsion (Catioprost) and a BAK-preserved latanoprost solution in animal models.
- Source :
-
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics [J Ocul Pharmacol Ther] 2012 Oct; Vol. 28 (5), pp. 515-23. Date of Electronic Publication: 2012 Jun 06. - Publication Year :
- 2012
-
Abstract
- Purpose: Benzalkonium chloride (BAK), a common preservative in eye drops, can induce ocular surface toxicity that may decrease glaucoma therapy compliance. The ocular hypotensive effect, pharmacokinetic (PK) profiles, and local tolerance of a preservative-free latanoprost 0.005% cationic emulsion (Catioprost(®)), and a BAK-preserved latanoprost 0.005% solution (Xalatan(®)), were compared.<br />Methods: The ocular hypotensive effect was evaluated in monkeys with elevated intraocular pressure (IOP) induced by laser photocoagulation of the trabecular meshwork. Each monkey (n=8) received both latanoprost formulations once daily for 5 consecutive treatment days in a crossover design with at least a 2-week washout period between treatments. IOP was measured at baseline (on day 1, no instillation), on vehicle treatment day (day 0), and on treatment days 1, 3, and 5 before drug instillation and then hourly for 6 h. In rabbits, the ocular and systemic concentrations of latanoprost free acid were determined following a single instillation and the local tolerance of twice daily instillations over 28 days was assessed.<br />Results: Both the preservative-free and BAK-preserved latanoprost formulations shared the same efficacy profile with the maximum IOP reduction occurring 2 h after each morning dose (-15%, -20%, and -26%; -15%, -23%, and -23% on days 1, 3, and 5, respectively) and lasting through 24 h. The equivalence in efficacy was confirmed by the PK data demonstrating similar area under the curves (AUCs). While both formulations were well tolerated, the incidence of conjunctival hyperemia was reduced by 42% with the BAK-free latanoprost cationic emulsion.<br />Conclusions: In animal models, a preservative-free latanoprost cationic emulsion was as effective as Xalatan(®) for lowering IOP with an improved ocular tolerance profile.
- Subjects :
- Animals
Antihypertensive Agents adverse effects
Antihypertensive Agents chemistry
Antihypertensive Agents pharmacokinetics
Cations
Chemistry, Pharmaceutical
Disease Models, Animal
Dose-Response Relationship, Drug
Emulsions
Eye drug effects
Eye metabolism
Female
Latanoprost
Macaca fascicularis
Male
Ophthalmic Solutions
Prostaglandins F, Synthetic adverse effects
Prostaglandins F, Synthetic chemistry
Prostaglandins F, Synthetic pharmacokinetics
Rabbits
Tissue Distribution
Treatment Outcome
Antihypertensive Agents therapeutic use
Benzalkonium Compounds chemistry
Intraocular Pressure drug effects
Ocular Hypertension drug therapy
Preservatives, Pharmaceutical chemistry
Prostaglandins F, Synthetic therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1557-7732
- Volume :
- 28
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 22671995
- Full Text :
- https://doi.org/10.1089/jop.2011.0245