Background Chlorhexidine has been used as a surgical prophylaxis in patients allergic to povidone in order to reduce post-surgery infections.1
Purpose To develop a 0.05% chlorhexidine ophthalmic formulation and study its stability in different storage conditions: in fridge (5°C), at room temperature (20°C) and accelerated (40°C).
Material and methods Chlorhexidine 0.05% ophthalmic formulation was compounded in the pharmacy service by an aseptic technique, as starting products, chlorhexidine digluconate 20% (Acofarma), glacial acetic acid (Fagron), anhydride sodium acetate (Fagron) and water for injection (Braun) were used. The compounded drug was packed into a high-density poliethylene eye dropper.
The pH and osmolarity of the samples were subsequently checked. The determination of pH was made with pHmeter Hanna HI5221 and the osmolarity was made with Fiske Model 210.
Stability was determined by HPLC, Agilent 1260series HPLC System with a PAD detector.
Each sample was taken twice for each condition.
Results The organoleptic properties of the three formulas were acceptable. The pH and osmolarity results differed minimally between 0 and 6 months, less than a 5% difference in pH and less than a 10% difference in osmolarity. The values were:
The concentration fell below 10% at month 6.
Conclusion Chlorhexidine 0.05% eye drops can be compounded in the pharmacy service for allergic surgical patients. The drug meets the galenic requirements for ophthalmic preparations and can be stored at room temperature as well as in the fridge for a period of 3 months unopened.
Reference and/or acknowledgements
Merani R, McPherson ZE, Luckie AP, et al. Aqueous chlorhexidine for intravitreal injection antisepsis: a case series and review of the literature. Ophthalmol 2016;123:2588–94.
Reference and/or acknowledgementsNo conflict of interest.
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