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Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

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

C Dreno¹, T Gicquel², M Harry³

¹Pôle pharmaceutique, CHU Pontchaillou, 2, rue Henri-Le-Guilloux, 35033 Rennes cedex 9, France.

Annales Pharmaceutiques Francaises

|January 12, 2015

Summary

This study shows that a 2% phenylephrine hydrochloride eye drop solution is stable for 60 days at room temperature. This formulation is suitable for compounding larger batches for neonatal retinal examinations.

Keywords:

Biocompatibility Biocompatibilité Chlorhydrate de phényléphrine Collyre Enfant prématuré Eye drop Mass spectrometry Phenylephrine hydrochloride Premature infant Spectrométrie de masse Stability study Étude de stabilité

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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.