Advanced in vitro methods in generic drug product development

Zentiva is a generics manufacturer that is developing innovative processes to manufacture APIs, and to formulate the drug product itself.  It is using Pion instruments to better understand the API molecule’s behavior in-vivo and any potential risks to progression are critical in the development of new generic medicines. In this webinar the following topics will be covered:

• Physicochemical characterization of APIs using Pion’s SirusT3
• Screening of API solid forms using InForm
• Precipitation experiments on InForm – screening of precipitation inhibitors and description of factors influencing repeatability of the experiments
• MacroFlux – indirect identification of API-excipient interactions and risk mitigation for bioequivalence studies
• Rainbow fiber optic system – use for precipitating systems, comparison with standard offline analysis (UV/HPLC)