Article
Pharmacology & Pharmacy
Thorsten Verch, Cristiana Campa, Cyrille C. Chery, Ruth Frenkel, Timothy Graul, Nomalie Jaya, Bassam Nakhle, Jeremy Springall, Jason Starkey, Jette Wypych, Todd Ranheim
Summary: Analytical methods are crucial in the biopharmaceutical and vaccines industries for research, development, and manufacturing control. Analytical quality by design (AQbD) offers a systematic framework for continuous validation and robust assay. This paper expands on the concept of AQbD and provides implementation context and illustrative examples.
Article
Spectroscopy
Riccardo Deidda, Hermane T. Avohou, Elodie Dumont, Cedric Hubert, Philippe Hubert, Charlotte De Bleye, Eric Ziemons
Summary: The AQbD principles were applied to the development of SERS method by selecting crystal violet as the model compound and defining the analytical target profile, followed by risk assessment of critical method parameters and a screening study of aggregation agents. An I-optimal design was then implemented to optimize the analysis process.
JOURNAL OF RAMAN SPECTROSCOPY
(2022)
Review
Plant Sciences
Geonha Park, Min Kyoung Kim, Seung Hyeon Go, Minsik Choi, Young Pyo Jang
Summary: This review discusses the applications of AQbD in medicinal plant analysis, focusing on how to handle the analysis of multiple components and solve the challenges posed by the complexity of plant chemical and biological properties.
Article
Pharmacology & Pharmacy
Lucas Chiarentin, Catarina Cardoso, Margarida Miranda, Carla Vitorino
Summary: This paper applies Analytical Quality by Design (AQbD) principles to develop and validate a rheology method for topical creams as complex semisolid formulations. Risk assessment is carried out using an Ishikawa diagram and estimate failure mode, effects, and criticality analysis (FMECA). Critical method variables are identified and a 2(3) full factorial design is applied to understand their impact. The method is developed and validated following ICH guidelines. AQbD provides a comprehensive framework for the development of a reliable and effective rheology method for this type of formulation.
Article
Pharmacology & Pharmacy
Reka Szoleczky, Maria Budai-Szucs, Erzsebet Csanyi, Szilvia Berko, Peter Tonka-Nagy, Ildiko Csoka, Anita Kovacs
Summary: The aim of this study was to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter for diclofenac sodium hydrogel, by applying the analytical quality by design approach. The analytical target profile and critical method attributes were defined, and an initial risk assessment was conducted. High-risk parameters were identified and a test protocol was developed for the hydrogel system.
Article
Chemistry, Analytical
Jianhao Teng, Chunmei Zhu, Jinyuan Lyu, Linyu Pan, Meng Zhang, Fuli Zhang, Haoxiang Wu
Summary: The development of a robust UPLC analytical procedure for quantifying 10 impurities in TAF tablets using ALM and AQbD methods proved successful, highlighting the usefulness of these approaches for analytical procedure development and offering insights for future drug analysis methods.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2022)
Article
Multidisciplinary Sciences
Siva Krishna Muchakayala, Naresh Kumar Katari, Kalyan Kumar Saripella, Henele Schaaf, Vishnu Murthy Marisetti, Leela Prasad Kowtharapu, Sreekantha Babu Jonnalagadda
Summary: We report an ideal method for quantifying impurities in mycophenolate mofetil drug substances and their oral suspension preparations, utilizing quality by design (QbD) and green chemistry principles. The method conditions were optimized using a systematic central composite design, resulting in the best possible separation between critical pairs. The developed method was validated according to ICH and USP guidelines, showing specificity, recovery, linearity, and precision within acceptable ranges. The eco-friendliness and greenness of the method were also evaluated and found to be green.
SCIENTIFIC REPORTS
(2022)
Article
Biochemical Research Methods
Maira Ribeiro de Souza, Mariana Koetz, Renata Pereira Limberger, Amelia Teresinha Henriques
Summary: This study developed a high-performance liquid chromatography method for simultaneous quantification of multiple cannabinoids in C. sativa using an AQbD-driven approach. The method showed satisfactory selectivity, linearity, precision, and ruggedness, making it suitable for quality control of cannabis-based products.
PHYTOCHEMICAL ANALYSIS
(2022)
Article
Biochemical Research Methods
Elek Ferencz, Arnold Zoeldhegyi, Eva-Katalin Kelemen, Mona Obreja, Melinda Urkon, Emese Sipos, Gergo Toth, Imre Molnar, Zoltan-Istvan Szabo
Summary: Experimental design-based retention modeling provides advantages in chromatographic method development, such as increased method consistency, flexibility, and efficiency. Recent chapters published by ICH demonstrate the paradigm shift in model-based development strategies, known as the enhanced approach. This study investigates the impact of stationary phase chemistries on chromatographic method performance and provides insights for method optimization and selection.
JOURNAL OF CHROMATOGRAPHY A
(2022)
Review
Pharmacology & Pharmacy
Maram Suresh Gupta, Tegginamath Pramod Kumar, Devegowda Vishkante Gowda, Jessica M. Rosenholm
Summary: Orodispersible films (ODFs) are a unique pharmaceutical dosage form that can improve patient compliance and convenience, particularly for pediatric and geriatric populations. They have the potential to serve as carriers for drugs, herbal extracts, probiotics, and vaccines, while also aiding in drug loading, taste masking, and stability enhancement.
ADVANCED DRUG DELIVERY REVIEWS
(2021)
Article
Biochemistry & Molecular Biology
Kyoungmin Lee, Wokchul Yoo, Jin Hyun Jeong
Summary: This study developed a new method to control potential genotoxic impurities in the pharmaceutical industry. The method utilized gas chromatography with a mass spectrometry detector and employed expert knowledge and statistical software for selection and optimization. The method was validated and proved to accurately detect and quantify the target impurities.
Article
Chemistry, Medicinal
Kostas Gkountanas, Andelija Malenovic, Yannis Dotsikas
Summary: A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities is presented, following analytical quality-by-design (AQbD) principles. The method parameters were selected using experimental design and Monte Carlo simulations. The method was validated according to ICH guidelines and applied to the analysis of tablets containing bupropion hydrochloride.
Article
Engineering, Chemical
Alex Juckers, Petra Knerr, Frank Harms, Jochen Strube
Summary: Lyophilization is commonly used for preserving thermolabile products, with the main drawback being the long processing time. By implementing the quality by design (QbD) approach and process analytical technology (PAT), the process duration can be optimized for increased productivity while maintaining product safety.
Article
Pharmacology & Pharmacy
Jonas Pielenhofer, Sophie Luise Meiser, Karsten Gogoll, Anna-Maria Ciciliani, Mark Denny, Michael Klak, Berenice M. M. Lang, Petra Staubach, Stephan Grabbe, Hansjoerg Schild, Markus P. P. Radsak, Hilde Spahn-Langguth, Peter Langguth
Summary: This article demonstrates the application of quality by design (QbD) in the development of a nanoparticulate imiquimod emulsion gel formulation. The critical quality attributes (CQAs) and critical process parameters (CPPs) were identified and optimized, leading to consistent quality and minimal batch-to-batch variability. The model validation showed good correlation between predicted and observed values.
Article
Chemistry, Applied
Yasunori Abe, Kosuke Emori
Summary: This article describes a novel experimental design and statistical analysis method for identifying the critical process parameters (CPPs) of impurities in futibatinib. Through failure mode and effects analysis, 11 potential CPPs were identified for investigation. Orthogonal experiments and statistical analysis were used to analyze the factors influencing each impurity, and the details of the process parameters to be examined in commercial production were clarified.
ORGANIC PROCESS RESEARCH & DEVELOPMENT
(2022)
Review
Chemistry, Analytical
Claudia Campanale, Silvia Galafassi, Francesca Di Pippo, Iulian Pojar, Carmine Massarelli, Vito Felice Uricchio
Summary: Biodegradable plastic mulches (BDMs) have the potential to be an eco-friendly alternative to conventional plastic mulches in agriculture. However, their long-term impacts on soil ecosystems are still uncertain, and further research is needed. Incorporating BDMs into the soil may stimulate microbial activity, but there is also a risk of incomplete degradation and release of residual microplastics and additives.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Xuechi Yin, Sijie Liu, Deepak Kukkar, Jianlong Wang, Daohong Zhang, Ki-Hyun Kim
Summary: The lateral flow immunoassay strip is a classic and dominant tool in point-of-care detection, known for its portability and simplicity. However, current colored nanomaterials used as signal labels in LFIA have limited sensing potential, leading to the recognition of composite nanoparticles as alternatives to enhance sensitivity, signal readout diversity, anti-matrix interference, and cost-effectiveness.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Yaxin Cao, Longyi Shao, Timothy P. Jones, Wenjing Deng, M. Santosh, Pengju Liu, Cheng-Xue Yang, Yaowei Li, Daizhou Zhang, Kelly Berube
Summary: The toxicity of fibrous particles in ambient air can be higher than other types of particles. Microfibers can be organic or inorganic and their presence in the atmosphere as a result of human activity raises concerns for environmental and public health. Accurate collection, identification, and understanding of the health hazards associated with these fibers are crucial for mitigation strategies and protection of public health.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Chenchen Xie, Chen Meng, Huilin Liu, Baoguo Sun
Summary: The development of food hazard factor (FHF) detection has been moving towards on-site inspection and mobile law enforcement, calling for simple, fast, and affordable analysis technology to ensure food safety and quality. This review comprehensively summarizes the progress in research on smartphone-assisted MIP optosensors, focusing on the key issues of accuracy and sensitivity.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Guillem Peris-Pastor, Cristian Azorin, Jose Grau, Juan L. Benede, Alberto Chisvert
Summary: Green Analytical Chemistry plays an important role in every stage of method development, including sample preparation. Extraction techniques have evolved from conventional ones to a variety of miniaturized techniques in order to enhance analytical performance and ensure safety for operators and the environment. Green metric tools are used to evaluate the impact and sustainability of methods, with AGREEprep selected as the most suitable tool for evaluating published methods in various applications. The miniaturization of sample preparation strategies has led to the use of less and safer solvents, reduced waste generation and energy consumption, and improved portability and throughput.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Helena Hruskova, Roman Reminek, Frantisek Foret
Summary: This review article summarizes the progress and recent studies in offline electromigration preparative techniques between 2018 and 2023. It covers various techniques including electrophoresis, free-flow electrophoresis, isoelectric focusing, and isotachophoresis, providing theoretical aspects, trends, and solutions to existing limitations in each technique.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Mayank Garg, Nicole Pamme
Summary: This review focuses on the removal strategies of templates from molecularly imprinted polymers (MIPs) used in diagnostic biosensors. Chemical-based and electrochemical-based template extraction approaches are summarized and evaluated, providing guidance for researchers in the fields of analytical chemistry, diagnostics, and materials science for the design of MIP-based sensors.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Ivneet Banga, Anirban Paul, Nathan Kodjo Mintah Churcher, Ruchita Mahesh Kumar, Sriram Muthukumar, Shalini Prasad
Summary: Breathomics is an emerging field that focuses on analyzing exhaled breath to diagnose and monitor respiratory diseases. Electrochemical sensors, with their high sensitivity, selectivity, and low cost, play a significant role in breathomics and can be integrated into portable devices for point-of-care diagnosis.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Fabjola Bilo, Paola Cirelli, Laura Borgese
Summary: This review explores the application of X-ray fluorescence (XRF) spectrometry for elemental analysis of particulate matter (PM) in air quality monitoring. It discusses the fundamentals of XRF, experimental configurations, PM sampling devices and substrate, sample preparation strategies, qualitative and quantitative analysis, as well as the challenges faced by XRF in becoming a reliable analytical technique for PM analysis.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Hakim Faraji
Summary: The dispersive liquid-liquid microextraction (DLLME) technique is widely popular in analytical chemistry due to its high efficiency, cost-effectiveness, and simplicity. Recent advancements have addressed the limitations of DLLME, incorporating greener solvents, innovative dispersion strategies, and simplified procedures. These changes have made DLLME a more sustainable and efficient technique.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Sherin F. Hammad, Inas A. Abdallah, Alaa Bedair, Reda M. Abdelhameed, Marcello Locatelli, Fotouh R. Mansour
Summary: Carbon nanomaterials (CNMs) have excellent capabilities in terms of adsorption, enhanced oxidation, and photocatalysis, attracting widespread attention in different fields. Metal-organic frameworks (MOFs) have been widely used due to their regular network structure, porous nature, and large specific surface area. However, the instability of MOFs in aqueous solutions limits their applications in chemical sensing. Recent studies have focused on increasing the stability of MOFs in water-based matrices through chemical modifications using CNMs.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Alexandra Pape, Oliver J. Schmitz
Summary: Low temperature plasmas based on dielectric barrier discharges have emerged as a recent development in ion source research. These ion sources are applicable to heat-sensitive analytes and can ionize a wide range of compounds. Despite intensive research on important parameters such as configuration, shape, size, and materials in the past two decades, the actual ionization mechanism for all plasma gases has not been fully elucidated. This review provides an overview of atmospheric pressure ion sources, with a focus on plasma and dielectric barrier discharge based ion sources, summarizing the reactions occurring in the plasma and discussing the applications developed by different research groups.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Hai Xiong, Fengli Li, Linyu Zeng, Qiyu Lei
Summary: This review provides an overview of the emerging trends in the use of functional COF nanomaterials as biosensors for DNA/RNA detection. It summarizes the construction of DNA/RNA hybridized COF nanoprobes and their potential applications in bioanalyte detection, biosensing, biomarker imaging, and clinical biomedicine.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Bing Yan
Summary: This article summarizes the recent progress in logic gate computing and operation based on multiple luminescence response and chemical sensing for lanthanide functionalized MOF hybrid systems. The article first describes multi-color luminescence and the subsequent multiple luminescence response. The basic concept of logic gate operation and the advantages of lanthanide-based hybrid materials are then introduced. Reports on logic gate operation using pure lanthanide MOFs are provided, followed by a detailed summary of logic gate operations using lanthanide functionalized MOF hybrid materials. Additionally, the article discusses the practical luminescent detection of analytes by correlating the luminescence responsive signals and the concentration of different analytes. Finally, the article concludes with a prospect for this topic.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)
Review
Chemistry, Analytical
Brij Mohan, Gurjaspreet Singh, Rakesh Kumar Gupta, Pawan Kumar Sharma, Alexander A. Solovev, Armando J. L. Pombeiro, Peng Ren
Summary: Porous materials, particularly hydrogen-bonded organic frameworks (HOFs), have gained significant attention due to their versatile applications and unique properties such as well-defined crystalline structure and easy regeneration processes. This article provides a comprehensive overview of HOFs, including synthesis methods, hydrogen bonding motifs, recent advancements, and potential applications, offering valuable guidance for further exploration in this dynamic field.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY
(2024)