DEVELOPMENT AND CHARACTERIZATION OF PHARMACEUTICAL EXTRUSATES USING PROCESS ANALYTICAL TECHNOLOGY (PAT) TOOLS

• Grant number: 25/14227-4
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: September 01, 2025
• End date: August 31, 2026
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Gabriel Lima Barros de Araujo
• Grantee: Victória Cotinguiba de Abreu
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

This study aims to apply Process Analytical Technology (PAT) tools to evaluate the Critical Quality Attributes (CQAs) of itraconazole extrudates, with an emphasis on dosage, content uniformity, and the degree of drug amorphization. The incorporation of PAT tools provides greater assurance in development, manufacturing processes, and ultimately for patient safety. Throughout the study, physical mixtures and itraconazole extrudates will be prepared to build spectral libraries of the materials involved. Multivariate statistical techniques will be applied to interpret the data obtained through spectroscopy, and the results will be validated using conventional methods such as Differential Scanning Calorimetry (DSC) and X-ray Diffraction (XRD). The objective is to develop a robust spectral library that supports the monitoring and quality control during the pharmaceutical development of itraconazole extrudates. Additionally, if time and resources allow, other poorly soluble drugs (BCS Class II) may also be evaluated using the same proposed approach. (AU)