Profiles of drug substances, excipients, and related methodology最新文献

Ferulic acid (FA) is a common dietary phenolic compound in various fruits, vegetables, coffee, cereals, and plant-based products. FA is recognized for its potent antioxidant properties and has the potential to be a promising therapeutic agent across various health conditions, including cancer, diabetes, cardiovascular, neurological, and metabolic disorders, viral infections, and skin issues. Therefore, researchers have extensively studied FA and considered it a valuable ingredient for the pharmaceutical, food, and cosmetic industries. This chapter comprehensively reviews FA, covering its nomenclature, physicochemical properties, synthesis methods, and thermal behavior. Stability, indications, pharmacology, mechanism of action, and pharmacokinetics are discussed. Additionally, different analytical techniques used for the quantitative and qualitative determination of FA are presented.

Vortioxetine (VX) is a multimodal novel antidepressant drug that belongs to the class of serotonin modulators and simulators (SMS). It is widely used for the treatment of major depressive disorder (MDD). VX possesses a multimodal mechanism of action that includes inhibition of serotonin transporter (SERT) and direct modulation of serotonin receptors (i.e., 5-HT1A, 5-HT1B, 5-HT3, 5-HT1D, and 5-HT7). This monograph presents a comprehensive review that includes a description (i.e., taxonomy, nomenclature, impurities, etc.), different synthesis methods, physical characteristics (i.e., appearance, color, solubility, thermodynamic properties, etc.), methods of analysis (i.e., spectroscopic, chromatographic, electrochemical methods), stability and degradation, pharmacology (i.e., pharmacodynamics, pharmacokinetics), therapeutic uses, and adverse and toxic effects of VX.

Kinetic Exclusion Assay (KinExA) is a powerful analytical technology that has gained importance for its ability to accurately characterize the intermolecular interactions in terms of affinity, binding kinetics, stoichiometry, specificity, and quantitatively measure the concentrations of diverse molecules in various fields of applications. This review article provides a comprehensive addressing of KinExA, covering its theoretical foundations, characteristics, instrumentation, and focusing on the applications of the technology for concentration measurements in diverse fields. The article begins by elucidating the fundamental concepts of KinExA, highlighting its principle of operation including the fundamental equations and assumptions underlying the technology, providing a sound understanding of the quantitative aspects of the technology. In addition, the article explores the key characteristics of KinExA that contribute to its widespread utilization. Furthermore, the review explores into the instrumentation of KinExA, outlining the components and operation of the instrument and assay setup. Finally, the review explores the diverse applications of KinExA in concentration measurements across various fields. These application fields include pharmaceutical and biomedical analysis clinical diagnostics, forensic analysis, environmental monitoring, food safety, heavy metals analysis, and diagnostic microbiology. The article emphasizes the reliability of KinExA in measuring analytes of diverse nature ranging from small molecules and micromodules. In conclusion, this review article provides a comprehensive overview of KinExA technology by demonstrating its broad utility as a valuable analytical tool, offering precise and reliable quantification of analytes in diverse sample matrices in different fields of applications.

Perindopril (PER) is classified as angiotensin-converting enzyme (ACE) inhibitors and is used primarily for the management of hypertension and cardiovascular conditions, including heart failure and stable coronary artery disease. Two primary salts of PER have been developed, perindopril arginine (PER-Arg) and perindopril erbumine (PER-E). This chapter presents a detailed overview on the physicochemical attributes of PER-Arg, molecular structure, synthetic pathway, crystallographic behavior, thermal stability, and UV absorbance profile of PER-Arg. Moreover, the chromatographic, spectrophotometric, spectrofluorimetric, biosensors, and radioimmunoassay methodologies employed for quantifying PER-Arg and PER-E, both as a standalone compound and in combination with other drugs in various matrices, are thoroughly discussed.

Rosuvastatin calcium (Ros-Ca) is a recent addition to the statin class of drugs. It lowers cholesterol levels by inhibiting its production in the liver. It is prescribed to control blood cholesterol levels when diet and exercise fail to manage hypercholesterolemia due to genetic reasons or other health problems. This chapter provides a complete review of Ros-Ca including its physiochemical characteristics, synthesis, and thermal analysis. It also encompasses various analytical approaches for quantitative and qualitative analysis of Ros-Ca.

This review explores the innovative approaches in localized drug delivery systems specifically designed to manage periodontal diseases (PD). The primary focus is on how these systems enhance the concentration of therapeutic agents at the site of infection, thereby minimizing systemic side effects and improving treatment outcomes. It emphasizes the role of biodegradable and bioadhesive polymers as carriers for sustained drug release. The chapter reviews different local drug delivery systems, such as fibers, films, chips, microparticles, and gels, highlighting their mechanisms of action, advantages, and limitations. It also discusses commonly used drugs, including chlorhexidine, doxycycline, metronidazole, and tetracycline, which are encapsulated within these systems to improve therapeutic efficacy. Additionally, the chapter delves into the polymers used in drug delivery, categorizing them into natural and synthetic biodegradable polymers, each offering unique benefits regarding biocompatibility and drug release kinetics. Polymeric therapeutics for controlled and sustained release further support the development of localized treatments. Overall, this chapter underscores the advancements in drug delivery technologies that promise to revolutionize the treatment of PD by reducing systemic side effects and optimizing therapeutic outcomes.

This chapter presents an overall account of cyclodextrins (CDs) with a brief description of the history, classification, and properties of these macromolecules. CDs act as complexing agents for drugs to form CD-drug inclusion complexes by various techniques. These complexes lead to the modification of the physicochemical properties of drugs to make them more soluble, chemically, and photochemically stable, and less toxic. It focuses in detail on various pharmaceutical uses of CDs and their derived forms in drug solubility, bioavailability, drug stability, drug delivery, and drug safety which have been specifically highlighted. The role of CDs and derivatives as excipients in the drug formulation of solid dosage forms, parenteral dosage forms, and anticancer drugs has been emphasized. Some other applications of CDs in cosmetics, environmental protection, food technology, and analytical methods have been described.

Linagliptin (LINA) is the first dipeptidyl peptidase IV (DPP-IV) inhibitor that could be administered orally to control hyperglycemia. It is indicated for controlling adult blood sugar levels that are diagnosed with diabetes mellitus type II. The current chapter provides a complete review of LINA including nomenclature, physiochemical characteristics, synthesis, and thermal analysis. Additionally, different analytical techniques used for quantitative and qualitative determination of LINA are presented.