Basic Formulation Characterization by Compendial in Vitro Dissolution Testing (USPII) (CAT#: STEM-B-0429-CJ)

Introduction

A biopharmaceutical formulation is a high-end product. It is tailored towards the specific drug substance, its specific characteristics and degradation profiles, and contains stabilizing excipients of various kinds. Knowing the characteristics of a biopharmaceutical formulation is not only relevant during the formulation exercise itself, but also when manufacturing aspects come into play.

Since drug molecules usually have different solid forms, including salts, polycrystals, eutectic, amorphous, hydrates and solvent compounds; moreover, different crystal forms of the same drug molecule may have significant differences in properties such as crystal structure, stability, producibility and bioavailability, which directly affect the efficacy and exploitability of the drug. If the best crystalline form is not well evaluated and selected for development, crystalline changes may occur in the late clinical stage, resulting in significant financial losses due to delayed marketing, and even more significant losses if the drug is withdrawn from the market due to crystalline changes after marketing.