EVALUATION OF TWO CRITICAL QUALITY ATTRIBUTES IN THE PRODUCTION OF SOLID DOSAGE FORMS USING NEAR INFRARED SPECTROSCOPY

• Autor: Cueva Mestanza, Ruben
• Formato: artículo
• Fecha de Publicación: 2018
• Institución: Sociedad Química del Perú
• Repositorio: Revista de la Sociedad Química del Perú
• Lenguaje: español
• OAI Identifier: oai:rsqp.revistas.sqperu.org.pe:article/66
• Enlace del recurso: http://revistas.sqperu.org.pe/index.php/revistasqperu/article/view/66
• Nivel de acceso: acceso abierto
• Materia: near infrared spectroscopy; critical attributes; pharmaceutical solids; Process Analytical Technology (PAT); espectroscopia de infrarrojo cercano; atributos críticos; comprimidos farmacéuticos; Tecnología Analítica de Procesos (PAT)

The determination by means of near infrared spectroscopy of critical quality attributes, of interest for the industrial manufacture of pharmaceutical solids, is studied here in order to apply this new methodology more quickly and efficiently as an alternative to conventional methods. The mixing process of the components of an effervescent formula is studied in order to determine the final mixing time in a fast and reliable way, as well as the humidity in intermediate granules of chewable tablets. The objective is to build the quality of the final product, controlling critical quality attributes of intermediate products during the same process by applying Process Analytical Technology (PAT).