Researchers Studying Injectable Suspensions

FDA says CDER researchers are developing new methods and understandings to bridge the critical gap between the in vitro measurements and the in vivo performance of injectable suspensions. An agency online post says researchers developed new methods to understand the impact of flocculation (forming weakly bound agglomerates) state on drug dissolution.

“These recent investigations by CDER demonstrate that appropriately designed in vitro experiments can provide insight into product performance under clinically relevant conditions,” the report says. “The researchers found that there is a strong correlation between flocculation/deflocculation behavior and particle size distribution on the one hand and drug dissolution rate on the other, and this correlation has important ramifications for understanding the physical stability of suspensions as well as possible variations in clinical outcomes.”