API characterization – why dissolution testing can help you learn more about Active Ingredient.

Title : API characterization – why dissolution testing can help you learn more about Active Ingredient.

Abstract:

Dissolution is a critical parameter of pharmaceutical dosage forms. It is indeed an extremely powerful tool to acquire knowledge about pharmaceutical products. The dissolution techniques can also be used to learn more about the properties of the Active Pharmaceutical Ingredient (API). 2 techniques are used: the intrinsic dissolution using the stirring mechanism concept and the apparent dissolution using the flow though cell dissolution concept (known as USP4). Both techniques bring different information, but it is important to proceed with such API characterization. Such knowledge may obviously guide the development of a new formulation but can also be very valuable during the life cycle of any product, when considering post approval changes such as new sources/ suppliers of raw material and its possible impact on the performance of the drug product. During this webinar, these 2 API characterization techniques will be explained in detail, showing some clear case studies.

Biography:

Prior to joining SPS, Samir spent more than 10 years at Sandoz and Novartis, in Switzerland and France, participating to the development of analytical methods for agrochemical and pharmaceutical compounds and formulations. In 2005, he resigned from Novartis to create SPS Pharma Services which is the first and only CRO specializing in Dissolution and Release Testing. In April 2013, SPS moved to a new larger facility in Orleans (France) to provide a broader range of services to its clients, including cGMP routine testing. The facility has been successfully inspected by US FDA and is registered as Pharmaceutical Establishment for both US and Europe. Since beginning of 2022, SPS is fully integrated within SOTAX Group and Samir is now in charge of the business segment Pharma Services, which comprises of 3 sites located in Europe, America and Asia.