Research Progress of Raman Spectroscopy and Raman Imaging in Pharmaceutical Analysis.

The analytical investigation of the pharmaceutical process monitors the critical process parameters of the drug, beginning from its development until marketing and post-marketing, and appropriate corrective action can be taken to change the pharmaceutical design at any stage of the process. Advanced analytical methods, such as Raman spectroscopy, are particularly suitable for use in the field of drug analysis, especially for qualitative and quantitative work, due to the advantages of simple sample preparation, fast, non-destructive analysis speed and effective avoidance of moisture interference. Advanced Raman imaging techniques have gradually become a powerful alternative method for monitoring changes in polymorph distribution and active pharmaceutical ingredient distribution in drug processing and pharmacokinetics. Surface-enhanced Raman spectroscopy (SERS) has also solved the inherent insensitivity and fluorescence problems of Raman, which has made good progress in the field of illegal drug analysis. This review summarizes the application of Raman spectroscopy and imaging technology, which are used in the qualitative and quantitative analysis of solid tablets, quality control of the production process, drug crystal analysis, illegal drug analysis, and monitoring of drug dissolution and release in the field of drug analysis in recent years.

Coupling of NIR Spectroscopy and Chemometrics for the Quantification of Dexamethasone in Pharmaceutical Formulations.

Counterfeit or substandard drugs are pharmaceutical formulations in which the active pharmaceutical ingredients (APIs) have been replaced or ingredients do not comply with the drug leaflet. With the outbreak of the COVID-19 pandemic, fraud associated with the preparation of substandard or counterfeit drugs is expected to grow, undermining health systems already weakened by the state of emergency. Analytical chemistry plays a key role in tackling this problem, and in implementing strategies that permit the recognition of uncompliant drugs. In light of this, the present work represents a feasibility study for the development of a NIR-based tool for the quantification of dexamethasone in mixtures of excipients (starch and lactose). Two different regression strategies were tested. The first, based on the coupling of NIR spectra and Partial Least Squares (PLS) provided good results (root mean square error in prediction (RMSEP) of 720 mg/kg), but the most accurate was the second, a strategy exploiting sequential preprocessing through orthogonalization (SPORT), which led (on the external set of mixtures) to an R2pred of 0.9044, and an RMSEP of 450 mg/kg. Eventually, Variable Importance in Projection (VIP) was applied to interpret the obtained results and determine which spectral regions contribute most to the SPORT model.

A NEW WINDOW OF OPPORTUNITY FOR BRAZILIAN API MARKET

Brazil produces only 5% of the active pharmaceutical ingredients needed to the manufacture of medicines. Recent changes on regulations and the COVID-19 pandemic could open the Brazilian market to a new window of opportunity where continuous manufacturing can play an important role to secure pharmaceutical supply chain. © 2022 TeknoScienze. All rights reserved.

Occurrence, transformation, bioaccumulation, risk and analysis of pharmaceutical and personal care products from wastewater: a review.

Almost all aspects of society from food security to disease control and prevention have benefited from pharmaceutical and personal care products, yet these products are a major source of contamination that ends up in wastewater and ecosystems. This issue has been sharply accentuated during the coronavirus disease pandemic 2019 (COVID-19) due to the higher use of disinfectants and other products. Here we review pharmaceutical and personal care products with focus on their occurrence in the environment, detection, risk, and removal. Supplementary Information: The online version contains supplementary material available at 10.1007/s10311-022-01498-7.

Forensic analysis of cosmetic smudges using surface-assisted laser desorption/ionization mass spectrometry: recovery and ageing study

Owing to its tendency to persist over prolonged periods, cosmetic evidence recovered from crime scenes can assist in linking a suspect to a certain crime or victim, or exonerating a suspect. This work presents a preliminary study in which surface-assisted laser desorption/ionization-mass spectrometry (SALDI-MS) was employed to analyze five cosmetic products recovered from different surfaces and collected at different time points. Topical over-the-counter (OTC) preparations, including Bepanthen cream, Reparil gel, Eucerin cream, Soskin serum, and Clofen creamagel containing dexpanthenol, diethylamine salicylate, urea, salicylic acid (SA), and diclofenac sodium (DCS) as active pharmaceutical ingredients (APIs), respectively, were used in this study. Due to their intricate nature and texture, five cosmetic product smudges were freshly deposited in small amounts on the target plate and directly subjected to SALDI-MS analysis without first performing an extraction. The five APIs were successfully detected, along with other ingredients present in the intricate cosmetic matrices;the presence of waxes and polymers in the preparations did not hinder ionization of the target analytes. Since only trace amounts of cosmetics are often encountered at crime scenes;therefore, limits of detection (LOD) were determined for each API using optimum solvents. The LOD were determined as 300, 30, 6, 1.20, and 600 ng/mL for dexpanthenol, salicylate, urea, SA, and DCS, respectively. Furthermore, the relative standard deviations of the amounts of each API detected were calculated and estimated to be between 0.40 and 17.95%, indicating good reproducibility of the results. Subsequently, models of forensic samples were prepared wherein cosmetic smudges were deposited on three different surfaces (plastic, glass, and stainless steel) and recovered via extraction and swabbing. The model indicated that direct swabbing of the sample onto the target plate was the best recovery approach which, owing to its simplicity, can be implemented at a crime scene. Finally, an ageing study was performed, which showed successful detection of all the APIs on their optimum surfaces, even after 38 days post-deposition. The imposed lockdown during the global COVID-19 pandemic has increased the necessity for more advanced recovery and detection techniques that can coincide with massive delays and sample backlogs in forensic laboratories. Therefore, SALDI-MS provides better discrimination power, faster analysis duration, and reduces the matrix effect when employed for small sample volumes, such as cosmetic smudges.

Industrially Relevant Enzyme Cascades for Drug Synthesis and Their Ecological Assessment.

Environmentally friendly and sustainable processes for the production of active pharmaceutical ingredients (APIs) gain increasing attention. Biocatalytic synthesis routes with enzyme cascades support many stated green production principles, for example, the reduced need for solvents or the biodegradability of enzymes. Multi-enzyme reactions have even more advantages such as the shift of the equilibrium towards the product side, no intermediate isolation, and the synthesis of complex molecules in one reaction pot. Despite the intriguing benefits, only a few enzyme cascades have been applied in the pharmaceutical industry so far. However, several new enzyme cascades are currently being developed in research that could be of great importance to the pharmaceutical industry. Here, we present multi-enzymatic reactions for API synthesis that are close to an industrial application. Their performances are comparable or exceed their chemical counterparts. A few enzyme cascades that are still in development are also introduced in this review. Economic and ecological considerations are made for some example cascades to assess their environmental friendliness and applicability.

Self‐Adaptive Plasma Chemistry and Intelligent Plasma Medicine

Plasma‐based biomedical applications rely on the reactive oxygen and nitrogen species generated in cold atmospheric plasmas, where complex chemical kinetic schemes occur. The optimization of plasma medicine is thus required for each specific biomedical purpose. In the view of pharmacology, it is to optimize the active pharmaceutical ingredients. This work is thus the first attempt of such a complex task utilizing the recent development of machine learning technologies. Herein, a general method of passive plasma chemical diagnostics and optimization in real time is proposed. Based on spontaneous emission spectroscopy, an artificial neural network provides the gas chemical compositions along with other information such as temperatures. The information further passes through the second neural network which outputs the adjustments of external control inputs including energy, gas injections, and extractions to optimize the plasma chemistry.

Recycling Old Antibiotics with Ionic Liquids.

Antibiotics are considered one of the great "miracles" of the 20th century. Now in the 21st century in the post-antibiotic era, the miracle is turning into a nightmare, due to the growing problem of the resistance of microorganisms to classic antimicrobials and the non-investment by the pharmaceutical industry in new antimicrobial agents. Unfortunately, the current COVID-19 pandemic has demonstrated the global risks associated with uncontrolled infections and the various forms of impact that such a pandemic may have on the economy and on social habits besides the associated morbidity and mortality. Therefore, there is an urgent need to recycle classic antibiotics, as is the case in the use of ionic liquids (ILs) based on antibiotics. Thus, the aim of the present review is to summarize the data on ILs, mainly those with antimicrobial action and especially against resistant strains. The main conclusions of this article are that ILs are flexible due to their ability to modulate cations and anions as a salt, making it possible to combine the properties of both and multiplying the activity of separate cations and anions. Also, these compounds have low cost methods of production, which makes it highly attractive to explore them, especially as antimicrobial agents and against resistant strains. ILs may further be combined with other therapeutic strategies, such as phage or lysine therapy, enhancing the therapeutic arsenal needed to fight this worldwide problem of antibacterial resistance. Thus, the use of ILs as antibiotics by themselves or together with phage therapy and lysine therapy are promising alternatives against pathogenic microorganisms, and may have the possibility to be used in new ways in order to restrain uncontrolled infections.

Are Myths and Preconceptions Preventing us from Applying Ionic Liquid Forms of Antiviral Medicines to the Current Health Crisis?

At the moment, there are no U.S. Food and Drug Administration (U.S. FDA)-approved drugs for the treatment of COVID-19, although several antiviral drugs are available for repurposing. Many of these drugs suffer from polymorphic transformations with changes in the drug's safety and efficacy; many are poorly soluble, poorly bioavailable drugs. Current tools to reformulate antiviral APIs into safer and more bioavailable forms include pharmaceutical salts and cocrystals, even though it is difficult to classify solid forms into these regulatory-wise mutually exclusive categories. Pure liquid salt forms of APIs, ionic liquids that incorporate APIs into their structures (API-ILs) present all the advantages that salt forms provide from a pharmaceutical standpoint, without being subject to solid-state matter problems. In this perspective article, the myths and the most voiced concerns holding back implementation of API-ILs are examined, and two case studies of API-ILs antivirals (the amphoteric acyclovir and GSK2838232) are presented in detail, with a focus on drug property improvement. We advocate that the industry should consider the advantages of API-ILs which could be the genesis of disruptive innovation and believe that in order for the industry to grow and develop, the industry should be comfortable with a certain element of risk because progress often only comes from trying something different.

The consequence of COVID-19 on the global supply of medical products: Why Indian generics matter for the world?

While the world is facing the urgency of the COVID-19 pandemic, policymakers must plan for the direct response to the outbreak while minimising its collateral impact. Maintaining the supply chain of pharmaceutical products is not only paramount to cover the immediate medical response but will be fundamental to reducing disruption of the healthcare delivery system, which requires constant medicines, diagnostic tools and vaccines for smooth functioning. In this equation, the role of the Indian pharmaceutical industry will not only be critical to meet the domestic need of over 1.3 billion inhabitants but will equally be important for the rest of the world, including wealthy economies. Preventing a significant disruption of the Indian pharmaceutical supply chain during the outbreak and preparing it for large scale production for COVID-19 therapeutic or preventive medical products will not only help India but will assist the global response to this outbreak.