Emulsions for IV Application - Particle Size by DLS

Intravenous infusions are administered directly into thebloodstream, and thus do not pass through the protectivefilters of the digestive system before being circulatedthrough somewhat vulnerable areas, such as the heart andlungs. A common risk from intravenous infusions iscontamination by particles that are not visible to the eye.

Contamination can have many sources, includingunwanted chemical reactions of the drug, incompatibilitywith other drugs or glass ware, rubber particles from theproduct's container, or precipitation of the drug. Precipitation is caused by low or decreased drug solubility,which can arise through too-high drug concentration, orthrough the solvent’s pH or ionic strength. If the drug ismore lipophilic and hard to dissolve or disperse in water, itis more likely that particles may precipitate.

These unwanted particles can lead to severe problemssuch as heart attacks, phlebitis, thrombosis or embolismsin the lung. Particles can arise during production orstorage, and can be caused by glass ware, dust,precipitation of the drug, rubber or any other material incontact with the product.

In addition to the health risks, there are also financialconsequences that should be considered. Contaminationby particles can lead to extended hospital stays andtreatments, which generally carry high costs.

Therefore, for quality-control purposes, it is important tocheck for such unwanted particles.

Get the document

To receive this document please enter your email below.