In Vitro Release Testing of Non-oral Complex Dosage Forms

Synopsis

New types of formulations and drug delivery technologies call for a new approach to in-vitro drug release testing and traditional dissolution methods are not tailored to these novel dosage forms. Products such as medical devices, combination products, injectable suspensions, microspheres and other parenteral products can be challenging when it comes to the development of an in vitro release or dissolution method. More flexible techniques such as the flow through cell may be needed to fulfill the requirements of such complex formulations.

It is of importance to use suitable method development strategies to characterize the release properties of the formulation as well as the dissolution properties of the Active Ingredient (API). That way, in vitro methods may serve either as formulation screening tool, to correlated in vitro results with in vivo performance or to control the quality of commercial products thus ensuring batch-to-batch consistency.

This lecture will discuss current and new applications related to non-conventional dosage forms.