Eye Drops leakage and Discoloration Market complaints investigation and Packaging Solution
Abstract:
This article investigates the recurring market complaints of leakage and discoloration in ophthalmic (eye drop) products, particularly within the United States. The study systematically examines three primary con tributing factors: cap and bottle design flaws, polymer incompatibility with the drug product, and leachables originating from bottle labels. Structural deficiencies in the cap, such as misaligned or improperly sized spikes, are identified as significant contributors to leakage. Discoloration is attributed to excessive pigments and addi tives in polymer materials, which leach into the formulation over time. Additionally, printed labels containing photoinitiators and adhesives contribute further contamination, posing risks such as toxicity, assay interfer ence, and pH variation. A case study on UV-curable printing inks highlights the migration of extractables into pharmaceutical products, emphasizing the importance of calculating the Analytical Evaluation Threshold (AET). The findings underscore the need for a holistic approach in packaging design—integrating proper ma terial selection, label chemistry evaluation, and component compatibility—to ensure product stability, patient safety, and regulatory compliance.
