Mechanical Inclusions in Ophthalmic Drugs

Analytical results for different dosage forms of ophthalmic drugs for the quality indicator “Particular contamination – subvisible particles” are presented. The possible analytical methods and regulatory requirements applicable to the quality of ophthalmic drugs for this parameter are discussed. Analytical results for subvisible particulate matter in ophthalmic dosage forms (40 samples) are presented. The need to introduce modern standardization of subvisible particulate matter in eye drops that is harmonized with leading pharmacopoeias is demonstrated.