Pérez García, Dustin E.

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    Desarrollo de método cuantitativo para la determinación del contenido de humedad en el proceso de granulación de un medicamento utilizando la tecnología de infrarrojo cercano
    (2011) Pérez García, Dustin E.; Hernández Rivera, Samuel P.; College of Arts and Sciences - Sciences; Román, Félix R; Morell, Luis A.; Department of Chemistry; Banerjee, Jayanta
    The granulation process is one of the most important processes in the manufacture of a pharmaceutical product. This is due to that in this manufacturing step the active ingredient (AI) is mixed with the excipients. One type of granulation, the wet granulation is very common in pharmaceutical manufacturing. In wet granulation a binder in an aqueous solution is applied to form the desired granulation. Once the granules are formed they have to be dried to eliminate the water content, to ensure that it complies with the established specifications. The water content in the product is closely related to its product stability. It is very important to monitor the water content during this process because adequate moisture content will provide good flowability, density and compressibility characteristics, without affecting significantly the product stability. Today, thanks to the implementation of chemometric methods, near Infrared spectroscopy (NIRS) can be used for the on-line and off-line as well at-line and in-line monitoring in the granulation process to know the moisture content level in a quick manner and even at a “real time” in an exact, precise and reliable manner. In this paper I will explain the development and validation of various analytical methods using the NIRS technology, complying with the minimum requirements established by the International Conference on Harmonization (ICH) and the European Medicines Agency (EMEA).