The thermodynamic pharma challenge: A cross-cutting perspective

IF 4.3 3区医学 Q1 PHARMACOLOGY & PHARMACY

European Journal of Pharmaceutical Sciences Pub Date : 2025-06-23 DOI:10.1016/j.ejps.2025.107178

Gabriele Sadowski , Georgios M. Kontogeorgis , Fiora Artusio , Dimitrios I. Gerogiorgis , Grazia De Angelis , Antoon ten Kate , Jean-Charles de Hemptinne

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Abstract

The development of pharmaceutical products and processes is associated with inherent challenges related to the stability, safety and purity of products for therapeutic applications. Low solubility and bioavailability of newly developed active pharmaceutical ingredients are among the biggest challenges in pharmaceutical development today, as this affects >90 % of newly developed drug molecules. Therefore, thermodynamic research could and should play a crucial role in the modelling and measurement of thermodynamic and kinetic data required for the understanding and design of safe and stable pharmaceutical products as well as their efficient and reliable production. The sixth edition of the IUT Symposium at the ECCE/ECAB 2023 meeting therefore focused on this “Thermodynamic Pharma Challenge”. The aim was to initiate an open discussion between stakeholders from industry and academia to share knowledge and identify bottlenecks that need to be addressed by the thermodynamic community. This manuscript addresses the topics discussed and presented in two sessions of the symposium: the panel discussion and the contributed talks. The symposium emphasized the need for advanced thermodynamic modeling to reduce the experimental effort required to estimate the solubility, stability and dissolution behavior of APIs. This is the most important prerequisite for the development of stable formulations and for increasing the efficiency of pharmaceutical production processes.

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热力学制药挑战：交叉视角

制药产品和工艺的开发与治疗应用产品的稳定性、安全性和纯度相关的固有挑战有关。新开发的活性药物成分的低溶解度和生物利用度是当今药物开发中最大的挑战之一，因为这影响了90%的新开发药物分子。因此，热力学研究可以而且应该在热力学和动力学数据的建模和测量中发挥至关重要的作用，这些数据是理解和设计安全稳定的药品以及高效可靠的生产所必需的。因此，在ECCE/ECAB 2023会议上举行的第六届IUT研讨会聚焦于这一“热力学制药挑战”。其目的是在工业界和学术界的利益相关者之间发起公开讨论，分享知识，并确定热力学社区需要解决的瓶颈。本手稿讨论的主题，并提出在研讨会的两个会议：小组讨论和贡献的会谈。研讨会强调需要先进的热力学建模，以减少估计api的溶解度、稳定性和溶解行为所需的实验努力。这是开发稳定配方和提高药品生产过程效率的最重要的先决条件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Pharmaceutical Sciences 医学-药学

CiteScore

9.60

自引率

2.20%

发文量

248

审稿时长

50 days

期刊介绍： The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.