Nitrosamine contamination of pharmaceuticals: Cases in Japan, formation mechanisms, detection methods, regulatory perspectives, and insights DOI Creative Commons
Genichiro Tsuji, Hidetomo Yokoo, Yosuke Demizu

и другие.

Journal of Pharmaceutical and Biomedical Analysis Open, Год журнала: 2024, Номер 4, С. 100034 - 100034

Опубликована: Июль 27, 2024

In recent years, mutagenic nitrosamines, such as N-nitrosodimethylamine, have been detected in medicine. This has led to global product recalls and long-term supply suspensions by pharmaceutical companies consequent clinical impacts. Measures control nitrosamines medicine, including detection methods clarification of contamination routes, are being implemented worldwide. this review, we focus on case reports nitrosamine drug products Japan, formation mechanisms during manufacturing storage, well methods. We also discuss the acceptable intake (ng/day) chemically synthesized substances human drugs (including products) US, EU, Japan. Overall, medicines is expected remain a public health issue. Therefore, using new technologies detailed analysis necessary. However, excessive regulation may cause essential shortages owing recall; therefore, realistic prudent response based regulatory science needed.

Язык: Английский

Application of an Interdisciplinary Approach to Form Selection in Drug Development DOI
Darren L. Reid,

Margaret M. Faul,

Vilmalí López-Mejías

и другие.

Organic Process Research & Development, Год журнала: 2025, Номер unknown

Опубликована: Янв. 25, 2025

Язык: Английский

Процитировано

1

Laccase-based biocatalytic systems application in sustainable degradation of pharmaceutically active contaminants DOI Creative Commons

Anil Kumar Singh,

Pedro Abellanas-Pérez, Diandra de Andrades

и другие.

Journal of Hazardous Materials, Год журнала: 2024, Номер 485, С. 136803 - 136803

Опубликована: Дек. 7, 2024

The outflow of pharmaceutically active chemicals (PhACs) exerts a negative impact on biological systems even at extremely low concentrations. For instance, enormous threats to human and aquatic species have resulted from the widespread use antibiotics in ecosystems, which stimulate emergence formation antibiotic-resistant bacterial associated genes. Additionally, it is challenging eliminate these PhACs by employing conventional physicochemical water treatment techniques. Enzymatic approaches, including laccase, been identified as promising alternative broad array matrices. However, their application environmental bioremediation hindered several factors, enzyme's stability its location aqueous environment. Such obstacles may be surmounted laccase immobilization, enables enhanced (including inactivation caused substrate), thus improved catalysis. This review emphasizes potential hazards organisms within detection concentration range ngL-1 µgL-1, well deployment laccase-based multifunctional biocatalytic for environmentally friendly mitigation anticancer drugs, analgesics/NSAIDs, antibiotics, antiepileptic agents, beta blockers micropollutants. approach could reduce underlying toxicological consequences. In addition, current developments, applications, viewpoints focused computer-assisted investigations laccase-PhACs binding enzyme cavities degradability prediction.

Язык: Английский

Процитировано

4

Stability of the antibiotic ceftaroline fosamil with focus on degradation products and decomposition pathways – integrative analysis by LC-DAD, ESI-QTOF and in silico prediction DOI

Michael W. Mendes,

Lilian F. Machioli, Graciela Carlos

и другие.

Journal of Pharmaceutical and Biomedical Analysis, Год журнала: 2025, Номер unknown, С. 116876 - 116876

Опубликована: Апрель 1, 2025

Язык: Английский

Процитировано

0

A Novel Linear Discriminant Analysis Approach for In Silico Prediction of Amlodipine Besylate Degradation in the Presence of a Second Drug in Combination DOI

Laltanpuii Chenkual,

Dimple S. Lalchandani, Pawan Kumar Porwal

и другие.

Next research., Год журнала: 2025, Номер unknown, С. 100409 - 100409

Опубликована: Май 1, 2025

Язык: Английский

Процитировано

0

Resources for Accelerating Medicine Discovery DOI

Maria Cristina Garcia‐Paredes,

Pushkar G. Ghanekar,

Rachel K. Chambers

и другие.

Burger's Medicinal Chemistry and Drug Discovery, Год журнала: 2025, Номер unknown, С. 1 - 57

Опубликована: Май 26, 2025

Abstract Using artificial intelligence and machine learning, computational tools are increasingly accelerating new medicine discovery. Applications to the stages of drug discovery, including target identification, hit lead optimization, developability assessment, described. This chapter provides a compilation databases, software packages, web‐based applications for evaluation, optimization molecules.

Язык: Английский

Процитировано

0

An amalgamation of LC-MS HDX and AI-based software for structure prediction of drug degradation products: An integrated step towards pharmaceutical development DOI
Sonali Jain,

Narasimha Swamy Palle,

Ananda Rajkumar Kuppusamy

и другие.

Analytical Chemistry Letters, Год журнала: 2024, Номер 14(2), С. 170 - 177

Опубликована: Апрель 11, 2024

AbstractStructure identification of drug degradation products is one the key components any pharmaceutical product development. Knowledge-based in-silico tools are widely used to predict probable and excipient interaction products. However, multiple structures same masses predicted through this software, which makes correct/exact structure difficult. In study, utilization a simple yet powerful analytical tool, LC-MS HDX was explored for improving predictive capability tool. For same, 5 drugs were selected as representative development workflow subjected stress study per ICH regulatory requirements. There in total 55 products, all possible Zeneth® software. The number labile hydrogens each obtained method. While scrutinizing with hydrogens, many false positive predictions could be ruled out. Out approach has helped predictability 45 corresponding ∼82% cases. It adopt industry by simply amalgamating practices AI prediction.GRAPHICAL ABSTRACTDisplay full sizeKeywords: Degradation impurity predictionLiquid Chromatography mass spectrometryStress degradationHydrogen-deuterium exchange

Язык: Английский

Процитировано

2

Nitrosamine contamination of pharmaceuticals: Cases in Japan, formation mechanisms, detection methods, regulatory perspectives, and insights DOI Creative Commons
Genichiro Tsuji, Hidetomo Yokoo, Yosuke Demizu

и другие.

Journal of Pharmaceutical and Biomedical Analysis Open, Год журнала: 2024, Номер 4, С. 100034 - 100034

Опубликована: Июль 27, 2024

In recent years, mutagenic nitrosamines, such as N-nitrosodimethylamine, have been detected in medicine. This has led to global product recalls and long-term supply suspensions by pharmaceutical companies consequent clinical impacts. Measures control nitrosamines medicine, including detection methods clarification of contamination routes, are being implemented worldwide. this review, we focus on case reports nitrosamine drug products Japan, formation mechanisms during manufacturing storage, well methods. We also discuss the acceptable intake (ng/day) chemically synthesized substances human drugs (including products) US, EU, Japan. Overall, medicines is expected remain a public health issue. Therefore, using new technologies detailed analysis necessary. However, excessive regulation may cause essential shortages owing recall; therefore, realistic prudent response based regulatory science needed.

Язык: Английский

Процитировано

1