Tacrolimus: Physicochemical stability challenges, analytical methods, and new formulations

IF 5.2 2区医学 Q1 PHARMACOLOGY & PHARMACY

International Journal of Pharmaceutics: X Pub Date : 2024-09-15 DOI:10.1016/j.ijpx.2024.100285

Sara Sajjadi , Ali Shayanfar , Farhad Kiafar , Mohammadreza Siahi-Shadbad

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Abstract

Tacrolimus, a potent immunosuppressant, is widely used in several formulations to treat organ rejection in transplant patients. However, its physicochemical stability poses significant challenges, including thermal instability, photostability issues, low solubility, and drug-excipient incompatibility. This review article focuses on the details of these challenges and discusses the analytical methods employed to study tacrolimus stability, such as thermal, spectroscopic, and chromatographic methods in different formulations. New formulations to enhance tacrolimus stability are explored, including lipid-based nanocarriers, polymers, and thin film freezing. Researchers and formulators can optimize tacrolimus formulations to improve efficacy and patient outcomes by understanding and addressing these stability challenges.

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他克莫司理化稳定性挑战、分析方法和新制剂

他克莫司是一种强效免疫抑制剂，被广泛应用于多种制剂中，用于治疗移植患者的器官排斥反应。然而，它的理化稳定性带来了巨大的挑战，包括热不稳定性、光稳定性问题、低溶解度以及药物与辅料不相容等。这篇综述文章重点介绍了这些挑战的细节，并讨论了研究他克莫司稳定性所采用的分析方法，如不同制剂中的热分析法、光谱法和色谱法。文章探讨了提高他克莫司稳定性的新配方，包括脂质纳米载体、聚合物和薄膜冷冻。研究人员和配方设计师可以通过了解和应对这些稳定性挑战来优化他克莫司配方，从而提高疗效和患者预后。

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来源期刊

International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

6.60

自引率

0.00%

发文量

审稿时长

24 days

期刊介绍： International Journal of Pharmaceutics: X offers authors with high-quality research who want to publish in a gold open access journal the opportunity to make their work immediately, permanently, and freely accessible. International Journal of Pharmaceutics: X authors will pay an article publishing charge (APC), have a choice of license options, and retain copyright. Please check the APC here. The journal is indexed in SCOPUS, PUBMED, PMC and DOAJ. The International Journal of Pharmaceutics is the second most cited journal in the "Pharmacy & Pharmacology" category out of 358 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.