Efficient Development Of Oral Drug Products: Selecting A Dissolution Media

By Deanna Mudie Ph.D., Principal Scientist, Lonza

A critical factor formulation experts must understand during the development of an oral solid dosage (OSD) form is that drug and dosage form properties can significantly limit the rate and extent of drug absorption and bioavailability if the OSD is not formulated with these considerations in mind. This leads to a risk of suboptimal drug delivery in the human body. In vivo dissolution testing is the gold standard for assessing oral bioperformance; however, a key component of this method is the dissolution media you use during testing.

With so many different media available that vary widely in properties and composition, it is important to select one that is tailored to the target population(s) of interest (i.e., fasted humans, fed humans, dogs, etc.) and can capture key gastrointestinal (GI) fluid properties affecting dissolution for your particular drug product.