pH stability of ophthalmic solutions. 2004

Monica Garcia-Valldecabres, and Antonio López-Alemany, and Miguel F Refojo
Ocular Surface, Cornea, and Contact Lenses Research Group, Department d'Optica, Universitat de València, València, Spain.

BACKGROUND In this study, we evaluated the pH value of 17 ophthalmic solutions, and we investigated whether the pH of these solutions changed over time after the bottle was opened. METHODS Fifteen bottles of each type of solution were chosen at random from different production lots. A 0.05-ml increment was taken from each bottle and was measured daily using a micropH 2002 Crison pH-meter over a period of 30 days. RESULTS The results revealed differences between the pH values of the solutions; nine solutions presented pH values within ocular comfort range and eight solutions presented pH values between 3.5 and 6.4. Ten solutions presented nonstatistically significant variations over time (p > 0.01) and seven solutions presented isolated but statistically significant variations. CONCLUSIONS We may assume that the nine solutions with pH values within the ocular comfort range will not produce initial discomfort. The solutions with acid pH values will produce initial discomfort. The solutions with nonstatistically significant pH variations over 30 days in relation to their initial pH values presented great stability.

UI MeSH Term Description Entries
D009883 Ophthalmic Solutions Sterile solutions that are intended for instillation into the eye. It does not include solutions for cleaning eyeglasses or CONTACT LENS SOLUTIONS. Eye Drop,Eyedrop,Eyedrops,Ophthalmic Solution,Eye Drops,Drop, Eye,Drops, Eye,Solution, Ophthalmic,Solutions, Ophthalmic
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006863 Hydrogen-Ion Concentration The normality of a solution with respect to HYDROGEN ions; H+. It is related to acidity measurements in most cases by pH pH,Concentration, Hydrogen-Ion,Concentrations, Hydrogen-Ion,Hydrogen Ion Concentration,Hydrogen-Ion Concentrations

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