A Guide to Technologies Used For The Analysis of Particulates in Injectable Drugs
In recent years, the delivery of biological drugs via prefilled syringe-style devices has rapidly become more prevalent, in direct response to consumer demand. However, there are some challenges associated with this delivery method. One such challenge is understanding and characterizing the formation of particulates in the subvisible and submicron range within the final drug product.
These particulates can result from manufacturing and fill issues, exposure of the product to temperature or mechanical stress, or reaction of the drug to excipients and contaminants, as a few examples. Since silicone oil is widely-used as a lubricant for syringe plungers and for coating the barrels of syringes, it is commonly found in droplet form as a contaminant in injectable formulations.
In some cases, it is thought that silicone oil droplets may act as a nucleus to promote the formation of protein aggregates in drug products, potentially increasing unwanted immunogenicity.
This presentation provides a comprehensive review of current and recently-developed technologies which can be used for the assessment of particular content in therapeutic formulations.