Excipients are chemical additives to medications. They are incorporated into all kinds of pharmaceuticals to fulfill formulation-related functions while remaining therapeutically inert. However, in a ...

Although the therapeutic components of drugs get most of the attention, fillers called excipients make up the bulk of most drugs. Excipients act as preservatives or contain active ingredients within ...

The US Food and Drug Administration (FDA) has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The pilot has the full support of ...

Nitrosamines arise via nitrosating agents (nitrites, NO2/NOx, nitrous acids/oxides) reacting with secondary/tertiary amines or some amides, yielding high-risk N-nitroso compounds. Regulatory actions ...

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a ...