THE INFLUENCE OF EXCIPIENTS ON STABILITY OF VISCOUS EYE DROPS WITH DEXPANTHENOL IN PHARMACEUTICAL PRACTICE
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Conventional eye drops exhibit weak bioavailability due to the unique physiology and anatomy of the eye. In order to increase eye drops viscosity, different concentrations of Carbopol® 940 (0.08% and 0.20%) were used. The aim of the study was to indicate the advantages and examine the influence of preservatives and the concentrations of viscosity increasing agents on the quality of magistral viscous eye drops with dexpanthenol (DXP). The quality of the prepared formulations was tested using physico-chemical methods and biological tests. pH Value measurement was done by the potentiometric method). Viscosity measurements of the samples were performed according to Ph. Eur. 9.0. DXP content was determined by reversed-phase high-pressure liquid chromatography. Sterility testing was performed using direct sample inoculation. The results indicate that pH values of eye drops with preservatives are lower than pH values of preservative-free formulations. All formulations have recovery values that meet the requirements of the European Pharmacopoeia. The DXP content in preservative-free eye drops increased slightly during testing, unlike the DXP content in eye drops with preservatives. The formulations remained sterile during 45 days after preparation, stored at room temperature, protected from light. DXP viscous eye drops may be prepared in pharmaceutical practice using the proposed viscosity increasing agent (Carbopol® 940) and preparation procedure. All formulations express stability for 45 days after preparation. Preservative-free DXP eye drops with Carbopol® 940 concentrations of 0.08% and 0.20% show maximal stability, provide an optimal concentration of DXP (3.0%), and therefore have an advantage in pharmaceutical practice.
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