Rev. OFIL 2017, 27;2:159-164
Fecha de recepción: 12/05/2016 – Fecha de aceptación: 13/07/2016
Riestra Ayora AC1,2, Berisa Prado S1, Fernández Llano L3, Navarro Hernández C3, Hernández Santos D3, Fanjul Bolado P3, Merayo-Lloves J1,2
1 Instituto Oftalmológico Fernández-Vega-Fundación de Investigación Oftalmológica (España)
2 Universidad de Oviedo (España)
3 DropSens (España)
Ana Cristina Riestra Ayora
Instituto Oftalmológico Fernández-Vega
(Servicio de Farmacia)
Avda Dres. Fernández Vega, 34
Correo electrónico: firstname.lastname@example.org
Objective: The purpose of this study is to determine the stability of a solution of 1.5% phenylephrine in sodium chloride 0.9% and balanced salt solution (BSS) under different environmental conditions using a method of electrochemical analysis.
Material and methods: The study conditions were defined according to the recommendations of the ICH stability guidelines. In addition to the quantification of the concentration of phenylephrine, osmolarity, pH and microbiological analysis of the formulations were assesed.
4 batches of 5 units of each formulation were manufactured. They were preserved under different environmental conditions: room temperature (25°C±2°C/60%RH±5%), refrigerator (5°C±3 °C) and freezer (-20°C±5°C). Determinations were made immediately, 1, 4, and 6 months after the preparation.
Results: No significant changes in concentration, understood as a variation of more than 5% from its initial value was detected. In addition there were not differences in physical attributes.
The most suitable pH values for ophthalmic application were obtained with BSS, remaining constant throughout the study. There were no significant differences in osmolality between preparations. All microbiological cultures were negative.
Conclusion: The formulation of 1.5% phenylephrine in BSS presents most suitable pH values for the intracamerular administration.Variations exceeding 5% in the concentration of phenylephrine were not detected during a period of 6 with the proposed method. There are no significant differences between the conservation at room temperature, in the refrigerator or freezer.
Key Words: Phenylephrine, drug stability, ophthalmology, drug formulation.