Dr. Samir Haddouchi
Managing Director
SOTAX Pharma Services
France
2023 Presentation
Automation is frequently considered as processes which requires a lot of complexity.
Instead, implementing automation allows to simplify the process, eliminate errors and reduce drastically results variability. However, there is no universal solution and it is of importance to tailor the technical solution based on the current organization of the lab and the type of products tested.
This presentation will introduce the advantages and drawbacks of automation and will go into details about how to transfer manual methods to automated systems.
2022 Presentation
New types of formulations and drug delivery technologies call for a new approach to in-vitro drug release testing and traditional dissolution methods are not tailored to these novel dosage forms.
Products such as medical devices, combination products, injectable suspensions, microspheres and other parenterals can be challenging when it comes to the development of an in vitro release or dissolution method. More flexible techniques such as the flow through cell may be needed to fulfill the requirements of such complex formulations.
It is of importance to use suitable method development strategies to characterize the release properties of the formulation as well as the dissolution properties of the Active Ingredient (API). That way, in vitro methods may serve either as formulation screening tool, to correlated in vitro results with in vivo performance or to control the quality of commercial products thus ensuring batch-to-batch consistency.
This lecture will discuss current and new applications related to non-conventional dosage forms.
Dissolution testing is of outmost importance when characterizing pharmaceutical products with regards to their performance as well as their quality.
In order to ensure reliable dissolution results, using properly qualified instruments is crucial.
This lecture will go through the various possible qualification approaches with their Pros and Cons.
About the speaker:
Prior to joining SPS Pharma Services, Samir spent more than 10 years at Sandoz and Novartis, participating to the development of analytical methods for residues of agrochemical compounds (using GC-MS or LC-MS, as well as automated sample preparation platforms such as Zymark Benchmate) or to the development of several pharmaceutical products, particularly in charge of the development of dissolution methods.
In 2005, he resigned from Novartis to create SPS Pharma Services in Clermont Ferrand which is the first and only CRO specialized in Dissolution and Release Testing. There, Samir managed SPS facility and was in charge of projects management.
In April 2013, SPS Pharma Services moved to a new larger facility in Orleans (France) in order to ensure better efficiency and 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 has been fully integrated within SOTAX Group and Samir is now in charge of the whole business segment Pharma Services, which comprises of 3 sites located in Europe, America and Asia.
Fields of interest and expertise: analytical development, in vitro dissolution and release testing (all techniques from USP1 to USP7), in vitro-in vivo correlations (IVIVC), formulation development, laboratory automation.