6533b824fe1ef96bd1280ac8

RESEARCH PRODUCT

pH stability of ophthalmic solutions.

Mónica Garcia-valldecabresMiguel F. RefojoAntonio López-alemany

subject

medicine.medical_specialtyChromatographybusiness.product_categoryGeneral MedicineHydrogen-Ion ConcentrationPh stabilityOphthalmic solutionsDrug StabilityOphthalmologymedicineBottleHumansOphthalmic SolutionsbusinessOptometryMathematics

description

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 non-statistically 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.

10.1016/s1529-1839(04)70035-4https://pubmed.ncbi.nlm.nih.gov/15058697