Tuesday, February 18, 2020
3:00 pm GMT   |   10:00 am EST (NA)   |   7:00 am PST (NA)

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Amorphous solid dispersions (ASDs) have been used extensively in the pharmaceutical industry for improving the solubility of poorly water-soluble drugs. Despite their advantages in terms of solubility, amorphous dispersions are not physically stable and tend to phase separate/crystallize with time, thus losing the initial solubility advantage. For that reason, it is essential to investigate the miscibility and the solubility limit of drugs in the polymeric matrixes. Determination of these limits allows defining a safe range of drug loads that can be manufactured and minimize potential stability issues that are inherent to supersaturated ASDs. In this webinar, we will present the most common methods used to determine drug solubility in polymeric matrices, including Hovione’s own thermodynamic approach to solubility determination.

In addition, we will also give an overview of the methodologies used to assess and predict long-term stability of amorphous materials and discuss the thermodynamic and kinetic contributions to drug crystallization in the solid state. In this section we will focus on the evaluation of the kinetics of relaxation and molecular mobility of amorphous materials, as a function of temperature. These are important aspects to be considered in a preliminary evaluation of stability, not only for pure amorphous drugs but also for supersaturated amorphous solid dispersions.

Key Learning Objectives:

• Identify advantages and disadvantages of the different methods used to determine drug-polymer solubility
• Understand the complexity of phenomena involved in physical stability of amorphous drugs
• Establish correlations between kinetic and thermodynamic parameters and stability

Watch On-Demand Webinar