Abstract: Predicting the Degradation Rate as a Function of Drug Load in Solid-State Drug Products

Predicting the Degradation Rate as a Function of Drug Load in Solid-State Drug Products

A model for predicting the rate of degradation as a function of drug load was recently developed (J. Pharm. Sci., 101(11), 2012, 4170-4177). In this case study, we explore both the mathematical model as well as the conceptual construct from which the model was developed.  We applied the model to a pediatric formulation of prasugrel hydrochloride of varying drug loads.  Our results confirm the validity of the mathematical model, but call into question the proposed conceptual construct.  We will discuss the generality of the model and how the use of this model can speed development of lower dose drug formulations typically found in pediatric dosing regimens.

Allison Dill – Lilly Pharmaceuticals