Amorphous solid dispersion of a binary formulation with felodipine and HPMC for 3D printed floating tablets

Gloria Mora-Castaño; Mónica Millán-Jiménez; Andreas Niederquell; Monica Schönenberger; Fatemeh Shojaie; Martin Kuentz; Isidoro Caraballo

doi:10.1016/j.ijpharm.2024.124215

Amorphous solid dispersion of a binary formulation with felodipine and HPMC for 3D printed floating tablets

Int J Pharm. 2024 May 11:658:124215. doi: 10.1016/j.ijpharm.2024.124215. Online ahead of print.

Authors

Gloria Mora-Castaño¹, Mónica Millán-Jiménez², Andreas Niederquell³, Monica Schönenberger⁴, Fatemeh Shojaie¹, Martin Kuentz³, Isidoro Caraballo¹

Affiliations

¹ Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, Universidad de Sevilla, 41012 Seville, Spain.
² Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, Universidad de Sevilla, 41012 Seville, Spain. Electronic address: momillan@us.es.
³ School of Life Sciences, University of Applied Sciences and Arts Northwestern Switzerland, CH 4132 Muttenz, Switzerland.
⁴ University of Basel, Swiss Nanoscience Institute, Nano Imaging Lab, Klingelbergstrasse 82, 4056 Basel, Switzerland.

PMID: 38740104
DOI: 10.1016/j.ijpharm.2024.124215

Abstract

This study focuses on the combination of three-dimensional printing (3DP) and amorphous solid dispersion (ASD) technologies for the manufacturing of gastroretentive floating tablets. Employing hot melt extrusion (HME) and fused deposition modeling (FDM), the study investigates the development of drug-loaded filaments and 3D printed (3DP) tablets containing felodipine as model drug and hydroxypropyl methylcellulose (HPMC) as the polymeric carrier. Prior to fabrication, solubility parameter estimation and molecular dynamics simulations were applied to predict drug-polymer interactions, which are crucial for ASD formation. Physical bulk and surface characterization complemented the quality control of both drug-loaded filaments and 3DP tablets. The analysis confirmed a successful amorphous dispersion of felodipine within the polymeric matrix. Furthermore, the low infill percentage and enclosed design of the 3DP tablet allowed for obtaining low-density systems. This structure resulted in buoyancy during the entire drug release process until a complete dissolution of the 3DP tablets (more than 8 h) was attained. The particular design made it possible for a single polymer to achieve a zero-order controlled release of the drug, which is considered the ideal kinetics for a gastroretentive system. Accordingly, this study can be seen as an advancement in ASD formulation for 3DP technology within pharmaceutics.

Keywords: 3D printing; Amorphous solid dispersion; Drug-loaded filaments; Fused deposition modeling; Gastroretentive floating tablets; Zero-order release.