Compounded 0.01% Atropine-What's in the Bottle?

Area of Science:

• Ophthalmology
• Pharmaceutical Sciences
• Pediatric Medicine

Background:

• Low-concentration atropine eye drops are increasingly used for myopia management in children.
• Compounding pharmacies play a role in providing these customized ophthalmic solutions.
• Standardization of compounded ophthalmic preparations is crucial for patient safety and efficacy.

Purpose of the Study:

• To assess the quality attributes of compounded 0.01% atropine ophthalmic solutions.
• To evaluate labeling and packaging practices for these compounded eye drops.
• To identify variations in formulation characteristics among different compounding pharmacies.

Main Methods:

• A convenience sample of 24 compounded 0.01% atropine ophthalmic solutions from nine US pharmacies was analyzed.
• Key quality attributes including atropine concentration, pH, osmolarity, and viscosity were measured.
• Labeling, packaging, and storage recommendations were documented.

Main Results:

• Significant variability was observed in bottle size (3.5-15 mL) and packaging (clear plastic bottles).
• Storage recommendations were inconsistent, with equal distribution among refrigeration, room temperature, and cool/dark/dry conditions.
• Beyond-use dates ranged widely (7-175 days), and 25% of samples had atropine concentrations below the 90% minimum target.

Conclusions:

• Compounding practices for 0.01% atropine ophthalmic solutions exhibit considerable inconsistency in formulation and labeling.
• Variations in quality attributes and storage recommendations may impact the stability and efficacy of these myopia control treatments.
• Further standardization is needed for compounded ophthalmic atropine used in pediatric myopia management.