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Open Access January 09, 2025

Advances in the Synthesis and Optimization of Pharmaceutical APIs: Trends and Techniques

Abstract The synthesis and optimization of Active Pharmaceutical Ingredients (APIs) is fundamental to pharmaceutical drug development, directly influencing drug efficacy, safety, and cost-effectiveness. Over recent years, significant advancements in synthetic methodologies and manufacturing technologies have transformed API production. This manuscript provides an overview of the latest innovations in API [...] Read more.
The synthesis and optimization of Active Pharmaceutical Ingredients (APIs) is fundamental to pharmaceutical drug development, directly influencing drug efficacy, safety, and cost-effectiveness. Over recent years, significant advancements in synthetic methodologies and manufacturing technologies have transformed API production. This manuscript provides an overview of the latest innovations in API synthesis, focusing on key techniques such as green chemistry, continuous flow chemistry, biocatalysis, and automation. Green chemistry principles, including solvent substitution and catalytic reactions, have enhanced sustainability by reducing waste and energy consumption. Continuous flow chemistry offers improved reaction control, scalability, and safety, while biocatalysis provides an eco-friendly alternative for synthesizing complex and chiral APIs. Additionally, the integration of automation and advanced process control using machine learning and real-time monitoring has optimized production efficiency and consistency. The manuscript also discusses the challenges associated with regulatory compliance and quality assurance, highlighting the role of advanced analytical techniques such as HPLC, NMR, and mass spectrometry in ensuring API purity. Looking ahead, personalized medicine and smart manufacturing technologies, including blockchain for traceability, are expected to drive further innovation in API production. This review concludes by emphasizing the need for continued advancements in sustainability, efficiency, and scalability to meet the evolving demands of the pharmaceutical industry, ultimately enabling the development of safer, more effective, and environmentally responsible medicines.
Review Article
Open Access June 30, 2024

Phytostabilization of Total Monocyclic Aromatic Hydrocarbon in Crude Oil-Contaminated Oxisol using Costus afer Plant

Abstract Costus afer, a known medicinal plant used in the removal of total monocyclic aromatic hydrocarbon (TMAH) in crude oil-contaminated soil add to the list of plant that has the potential to restore the soil quality. This study investigated the potential of Costus afer plant at various ages (7, 14, 21, 28, 35, and 42 days old) to biodegrade crude oil-contaminated soil. The group-balanced block design (GBBD) was used in establishing the experiment. TMAH was quantified by the standard method, according to USEPA method using gas chromatography-mass spectrometry (GC-MS). The contamination of 48kg of sandy loam soil was simulated by mixing 0.5, 1.0, and 1.5L of Bonny-Light crude oil with the soil in three separate vessels to achieve conditions of low (C1), medium(C2), and high(C3) contamination, respectively. An additional vessel with medium-level contaminated soil but no treatment (C4) served as the control. The Costus afer plants were nursed and transplanted at the stated ages to each vessel except the control. Controlled irrigation was applied, and the setups were housed to shield them from rainfall. After 90 days of treatment, results showed that the 7 days old Costus afer plants produced the highest amount of TMAH reduction of 96.5, 39.8, and 32.1%, for C1, C2 and C3, respectively, while the control (C4) was 9.45%. Furthermore, the sequence of TMAH reduction by the plants was 7 days old, 14 days old, 21 days old, 28 days old, 35 days old, and 42 days old. Thus, in addition to its medicinal value, Costus afer [...] Read more.
Costus afer, a known medicinal plant used in the removal of total monocyclic aromatic hydrocarbon (TMAH) in crude oil-contaminated soil add to the list of plant that has the potential to restore the soil quality. This study investigated the potential of Costus afer plant at various ages (7, 14, 21, 28, 35, and 42 days old) to biodegrade crude oil-contaminated soil. The group-balanced block design (GBBD) was used in establishing the experiment. TMAH was quantified by the standard method, according to USEPA method using gas chromatography-mass spectrometry (GC-MS). The contamination of 48kg of sandy loam soil was simulated by mixing 0.5, 1.0, and 1.5L of Bonny-Light crude oil with the soil in three separate vessels to achieve conditions of low (C1), medium(C2), and high(C3) contamination, respectively. An additional vessel with medium-level contaminated soil but no treatment (C4) served as the control. The Costus afer plants were nursed and transplanted at the stated ages to each vessel except the control. Controlled irrigation was applied, and the setups were housed to shield them from rainfall. After 90 days of treatment, results showed that the 7 days old Costus afer plants produced the highest amount of TMAH reduction of 96.5, 39.8, and 32.1%, for C1, C2 and C3, respectively, while the control (C4) was 9.45%. Furthermore, the sequence of TMAH reduction by the plants was 7 days old, 14 days old, 21 days old, 28 days old, 35 days old, and 42 days old. Thus, in addition to its medicinal value, Costus afer plant also has the potential to biodegrade TMAH in crude oil-contaminated sandy loam soil.
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Open Access February 02, 2023

Quantifying 64 drugs, illicit substances, and D- and L- isomers in human oral fluid with liquid-liquid extraction

Abstract Although human oral fluid has become more routine for quantitative drug detection in pain management, detecting a large scope of medications and substances is costly and technically challenging for laboratories. This paper presents a quantitative assay for 64 pain medications, illicit substances, and drug metabolites in human oral fluid. The novelty of this assay is that it was developed on an [...] Read more.
Although human oral fluid has become more routine for quantitative drug detection in pain management, detecting a large scope of medications and substances is costly and technically challenging for laboratories. This paper presents a quantitative assay for 64 pain medications, illicit substances, and drug metabolites in human oral fluid. The novelty of this assay is that it was developed on an older model AB SCIEX 4000 instrument and renders obscure the need for more technical and expensive laboratory equipment. This method includes addition of internal standard and a 2-step liquid-liquid extraction and dry-down step to concentrate and clean the samples. The samples were suspended in 50% MeOH in water and separation and detection was accomplished using triple quadrupole mass spectrometry (LC-MS/MS). Separation was achieved using reverse-phase liquid chromatography with detection by LC-MS/MS. A second injection was done in negative mode to determine THC-COOH concentration as an indicator of THC. An aliquot of the (already) extracted samples was analyzed for D- and L- isomers of amphetamine and methamphetamine using a chiral column. The standard curve spanned from 5 to 2000 ng/mL for most of the analytes (1 to 2000 ng/mL for fentanyl and THC-COOH) and up to 1000 ng/mL for 13 analytes. Pregabalin and gabapentin ranged from 25 to 2000 ng/mL. The result is a low-cost method for the sensitive detection of a wide-ranging oral fluid menu for pain management. This assay has a high sensitivity, and good precision and accuracy for all analytes with an older model mass spectrometer.
Article
Open Access January 01, 2023

Analysis of D- and L- Isomers of (Meth)amphetamine in Human K2EDTA Plasma

Abstract Methamphetamine and its metabolite amphetamine are frequently abused drugs. Whether obtained legally or from clandestine laboratories it is of relevance to determine the chiral makeup of these drugs for investigative purpose. Although urine and oral fluid matrices are commonly offered, less available to independent laboratories are techniques to verify dextro (D-) or levo (L-) (meth)amphetamine [...] Read more.
Methamphetamine and its metabolite amphetamine are frequently abused drugs. Whether obtained legally or from clandestine laboratories it is of relevance to determine the chiral makeup of these drugs for investigative purpose. Although urine and oral fluid matrices are commonly offered, less available to independent laboratories are techniques to verify dextro (D-) or levo (L-) (meth)amphetamine from human K2EDTA plasma. This paper outlines the development and validation of a method that includes the addition of internal standard and a two-step liquid-liquid extraction to remove the analytes from human K2EDTA plasma by triple quadrupole mass spectrometry (LC-MS/MS). The assay was validated according to the United States Food and Drug Administration and College of American Pathologists guidelines, including assessment of the following parameters in plasma validation samples: linear range, limit of detection, lower limit of quantitation, matrix effects, inter- and intra-day assay precision and accuracy, carry over, linearity of dilution, matrix effects and stability. The outcome is a validated and reliable method for the determination of D- and L- isomer concentration of meth(amphetamine) human plasma samples that can be easily adopted by independent clinical laboratories.
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Query parameters

Keyword:  Mass Spectrometry

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