The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010.

In an important step for modernizing drug formulation and biopharmaceutical development, FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new ...

The quality and composition of excipients can vary due to environmental factors, processing methods, raw material quality, manufacturing location changes, and even operator actions. The physical and ...

Functional classification of excipients for tablets and other pharmaceutical products differs for diverse purposes in pharmaceutical preparation and hence may require different material attributes to ...

WHEN YOU TAKE a pill, it's not all medicine. It says so right there on the box of your over-the-counter drug—if you are self-medicating—or in the fine print of the patient information sheet for your ...

When it comes to drugs, most of the attention goes to the active pharmaceutical ingredient. But typically the vast majority of what’s in a tablet, capsule, or liquid isn’t the active ingredient. A ...

Pharmaceutical excipients refer to the substances used in the production and formulation of medicines. They perform multiple functions in pharmaceutical preparations and are likely to affect the ...