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In this webinar key strategies for solubility and dissolution assessment of new drug products, drug product intermediates and APIs will be discussed.

In order to understand the dissolution behavior of drug products it is important to evaluate the solubility and supersaturation properties of the API. The extent to which the supersaturation is achieved depends on the API physical and thermodynamic properties. This means that there is a limit to the solubility enhancing potential of new drug product formulations. The importance of conducting such studies will most definitely benefit the formulation development ahead as will be demonstrated during the course of this webinar.

Dissolution is an analytical test commonly used by the pharmaceutical industry to guide both formulation design and drug product quality control. When considering the development of a dissolution method, three goals must be considered:

1. ensure consistent lot-to-lot quality for commercial products;
2. ensure in vivo in vitro correlation (IVIVC) and
3. be suitable as QC tool for daily routine. As this analytical tool is the best way of predicting a drug product performance, it is important to understand its basic principles and define the key strategies for method development.

Additionally, when considering drug product and drug product intermediates, the data that can be generated in this type of testing is of great value for new formulation screening at a pre-clinical phase. The use of biorelevant media that best reflects the biological environment can better forecast the performance of a new drug product, mainly concerning bioavailability and, ultimately, lower unsuccessful cases in clinical trials.

Key Learning objectives

• The importance of characterizing the API solubility prior to drug product development
• A systematic approach for developing dissolution methods
• The main goals of using biorelevant media: fostering pre-clinical drug product development

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