Characterization of Ternary Formulations for Hot Melt Extrusion: Impact of Plasticizers and Polymers on Solubility and Processability

• Grant number: 25/24259-0
• Support Opportunities: Scholarships abroad - Research Internship - Scientific Initiation
• Start date: March 02, 2026
• End date: July 01, 2026
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Gabriel Lima Barros de Araujo
• Grantee: Victória Cotinguiba de Abreu
• Supervisor: Walkiria Santos Schlindwein
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Institution abroad: De Montfort University, England
• Associated to the scholarship: 25/14227-4 - DEVELOPMENT AND CHARACTERIZATION OF PHARMACEUTICAL EXTRUSATES USING PROCESS ANALYTICAL TECHNOLOGY (PAT) TOOLS, BP.IC

Abstract

This project aims to optimize ternary formulations for Hot Melt Extrusion (HME) by systematically investigating the rheological impact and thermal properties of various polymers and plasticizers on drug solubility and processability. Recognizing HME as a critical solvent-free technique for enhancing the bioavailability of poorly soluble drugs through amorphous solid dispersions (ASDs), the research will leverage small amplitude oscillatory shear (SAOS) rheology and differential scanning calorimetry (DSC) to characterize drug-polymer-plasticizer interactions. The goal is to establish clear correlations between rheological parameters, such as complex viscosity and viscoelastic moduli, and the resulting solubility and physical stability of model drugs (e.g., itraconazole) within the extruded matrix.By understanding how different plasticizers and polymers influence melt flow behavior, processing temperatures, and drug-polymer miscibility, this study seeks to develop a rheology-guided framework for the rational design of formulations with model drugs. This approach will facilitate the selection of optimal excipient combinations and HME processing conditions, ultimately leading to improved drug loading, enhanced physical stability, and efficient manufacturing of high-quality ASDs.