ABSTRACT
This chapter will address the presence and nature of subvisible particulate matter in regard to these dosage forms, and in a general aspect for any medical product.
Particulate Matter The primary subjects of this chapter are particles and their size. The following discussion explores the lack of specificity for these subjects; to be comprehensive in our evaluation, we must not consider only particles that are one entity or characteristic, nor may visibility be described by a single “line-in-the-sand” size threshold or definition. In practice, the ultimate definition(s) of particulate matter must be suitably broad to allow us to consider many different aspects of character and size to make the products we develop most robust. Our discussion concerns particles and specifically, those we are unable to see. Our ability or inability to see them is not a simple matter, and dependent on many factors. Overall, our intent is to find the particle(s), understand them, and change something to alleviate their presence, inclusion, growth, or change. But first let us discuss the primary topics.
