In-vitro bioequivalence studies
The Morphologi G3-ID can be used to compare the Active Pharmaceutical Ingredients (API) within oral solid dose formualtions. Here we apply it to comparing innovator and generic versions of a product containing two APIs.
Introduction
Over 70 million patients in the world use a metered dose inhaler (MDI) for a variety of diseases, such as asthma, chronic obstructive pulmonary disease (COPD), and other lung diseases characterized by obstruction of airflow and shortness of breath.
Compared to other drug formulations, MDI's have unique differences with respect to formulation, container, closure, manufacturing, in-process and final controls and stability. The composition of an MDI formulation is crucial particularly in defining the physical stability and the performance characteristics of a MDI. Knowledge and information about parameters like particle density, particle size distribution, particle morphology, polymorphic forms of the active, solubility profile etc. are important from a generic manufacturer's perspective for achieving bioequivalence relative to the reference listed drug.
