Abstract
Background:
Today, the use of cyclodextrins (CDs) is a major concern in drug formulations to improve solubility and stability of compounds. It has been known that CDs can reduce the antimicrobial effectiveness of preservatives by formation of inclusion complexes.Objectives:
In this study the interaction between commonly used preservatives, benzalkonium chloride (BZCl) or methyl paraben (MP), with synthetic CDs (HP ?-CD or SBE ?-CD) in the presence or absence of ethylene diamine tetra acetic acid (EDTA), as a preservative potentiator, and fluorometholone was investigated.Materials and Methods:
The tests were performed during a 4 week period according to the preservative effectiveness test of USP 2010.Results:
The results showed that CDs reduce the effectiveness of BZCl and MP even in the presence of drug molecules. The only exception was HP ?-CD 5% solution with BZCl and EDTA which was effective against tested microorganisms both in the presence and absence of drug molecules.Conclusions:
The solution of HP ?-CD 5% with BZCl 0.02% and EDTA 0.1% was selected as a good carrier for dissolving fluorometholone for use as an eye drop.Keywords
Benzalkonium Compounds Cyclodextrins Ethylenediaminetetraacetic Acid Fluorometholone Parabens
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