Performance Enhancement Strategies for Low Solubility APIs – Do More with Less

Previously Aired on March 18th, 2021

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Overview

Close to 90% of drugs coming out of the drug discovery pipeline, have solubility limitations translating into poor bioavailability, which may ultimately result in clinical failures. Amorphous solid dispersions (ASDs) are an established platform to address bioavailability challenges due to low aqueous solubility.

The complexity of ASD development, added to the concerns on physical stability, are perceived as risks, however, the clinical and commercial success of ASD-based formulations stands as a driving force: to date, 24 FDA-approved therapies are commercially available.

This webinar will address the main challenges in the formulation of ASDs, highlighting the importance of integrated development and the synergies between pre-formulation and commercial manufacturing expertise.

We will also be presenting ASD HIPROS, our new state-of-the-art, science-based development platform for ASDs. This platform relies on the integration between formulation and analytical development, from API to drug product, coupled with the use of computational models, formulation databases and miniaturized high-throughput in vitro techniques.

We will further present how the use of our cutting-edge automated, spray drying equipment, coupled with in-silico formulation tools enable a high-throughput screening (HTS) approach for the development of ASDs.

What you will learn in this webinar:

• Understand the interplay between formulation and process aspects to achieve optimal bioavailability for amorphous dispersions

• Learn the importance of physiologically based dissolution for optimization and prediction of in-vivo performance

• Get expert insights on the use of computational models

Areas of Science/Research:

• Solubility enhancement

• Amorphous solid dispersions

• Fast track CMC

• In vitro performance characterization