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Updated: Oct 7, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Going green: Development of a sustainable lipid-based enteric coating formulation for low-dose aspirin
Sonja Schertel1, Carolina Corzo2, Lukas Leitner2
1University of Graz, Institute of Pharmaceutical Sciences, Department of Pharmaceutical Technology and Biopharmacy, 8010 Graz, Austria; Hermes Arzneimittel GmbH, Division Hermes Pharma, 82049 Pullach, Germany.
Abstract:
There is a rising awareness of pharmaceutical industry of both patient-centric and sustainable product development. Manufacturing of multiparticulate systems (MPS) with functional coating via solvent-free hot melt coating (HMC) can fulfill both requirements. An innovative lipid-based formulation was developed with the composition of palmitic acid and Grindsted® citrem BC-FS (BC-FS) for enteric coating of acetylsalicylic acid (ASA). The ASA crystals were directly hot melt coated to produce user-friendly low-dose ASA MPS for thromboembolism prophylaxis. Prior to HMC, rational boundaries for the process temperature were defined based on the melting and crystallization behavior of coating blend. Stability of coating in terms of resistance to heat stress and solidstate stability were screened via Fourier-transform infrared spectroscopy and x-ray diffraction. Exposure of coating blend to 100 °C for two hours did not cause any chemical degradation. Crystal growth of palmitic acid and polymorphic transformation in BC-FS were observed after storage under accelerated conditions, however did not significantly affect the ASA release from coating. The developed formulation is a unique solvent-free, lipid-based enteric composition and paves the way for sustainable green pharmaceutical manufacturing.
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