Formulation and stability study of a pediatric 2% phenylephrine hydrochloride eye drop solution

Area of Science:

• Ophthalmology
• Pharmaceutical Sciences
• Neonatal Care

Background:

• Routine hospital pharmacy preparation of 2% phenylephrine hydrochloride eye drops.
• Biocompatible solution for neonatal and premature infant retinal examination.
• Aseptic compounding conditions are critical.

Purpose of the Study:

• Evaluate the formulation and stability of a 2% phenylephrine hydrochloride eye drop solution.
• Assess physical, chemical, and microbiological stability over 60 days.
• Determine suitability for larger batch compounding.

Main Methods:

• Formulation using phenylephrine hydrochloride, disodium hydrogen phosphate, sterile water, and sodium chloride.
• Sterile filtration under ISO Class 5 conditions.
• Stability testing: visual inspection, osmolality, pH, phenylephrine assay (LC-MS), and sterility evaluation over 60 days at ambient temperature.

Main Results:

• The formulated solution maintained a pH of 6.90±0.05 and osmolality of 285±2 mOsm/kg.
• No precipitation or color change observed; sterility was maintained throughout the 60-day study.
• Liquid chromatography analysis indicated no significant degradation of phenylephrine.

Conclusions:

• The 2% phenylephrine hydrochloride eye drops are physically, chemically, and microbiologically stable for at least 60 days.
• Storage in type I amber glass vials at room temperature is appropriate.
• The stability supports compounding larger batch sizes for clinical use.