Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

Abstract

One of the fundamental principles guiding the pharmaceutical quality of parenteral products is to prevent injecting contaminants from microbiological, chemical or physical sources. It is just as difficult to ensure the absence of chemical and particulate contaminants in injectable products as it is to weigh up the microbiological risk. The problem of particulate matter is mainly related to the preparing and administrating of injectable drugs rather than through the contamination of marketed products. Particulate contamination also arises in situ during the simultaneous intravenous (IV) infusion of incompatible drugs. A complete overview of these problems in the context of IV infusion was carried out to assess their clinical impact. Many studies had already been performed on this theme, but the majority date from the 1970s and 1980s. Clinicians have expressed a renewed interest since the early 2000s, focusing on the impact of particles on patients.

Keywords

• intravenous infusion
• medical devices
• sub-visible particles
• particulate matter
• drug incompatibilities