Pion instruments to help develop innovative processes to develop APIs formulations
The assessment of the properties of an Active Pharmaceutical Ingredient (API) has historically been performed at later stages of generics development for quality control purposes rather than to determine potential performance risks. Now, scientists are looking for ways to gain a fundamental or mechanistic understanding on the behavior of the material or highlight its potential failure modes in vitro.
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.
During the presentation, 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)
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