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Discovery & Development Business Practice, Drug Delivery, Ingredients, Formulation, Small Molecules, Technology and Equipment, Dosage Forms, Analytical Science, Trends & Forecasts

In-vitro bioequivalence studies

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.

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