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Two vaccination-challenge trials were performed using a commercial infectious bronchitis virus (IBV) BR1 vaccine, given alone or combined with a commercial IBV Mass vaccine against challenges with IBV M41, 793B, D388 (QX), Q1, Brasil-1 or Variant 2 challenge viruses, which includes the IB viruses that are dominant in South America. The efficacy of the vaccines against the challenge viruses was investigated by determination of the ciliary activity of the tracheal epithelium after challenge. The level of protection induced by the IBV BR1 vaccine alone against the six IBV challenge strains, of which five were of heterologous genotypes, varied from 50% to 100% with an average of 80%. The level of protection induced by the combination of the IBV BR1 and IBV Mass vaccines against the six IBV challenge strains, of which four were of heterologous genotypes, varied from 80% to 100% with an average of 92%. Vaccination with IBV BR1 alone provided a high level of protection against most tested challenge viruses, though the combination of IBV BR1 and IBV Mass was more consistent, showing less variation and compliance with the criterium mentioned in the European Pharmacopoeia 10th edition (at least 80% protection) for all tested challenge viruses. These trials show that vaccination with a combination of IBV BR1 and IBV Mass vaccines provides high levels of protection against the circulating IBV strains in South America. [ABSTRACT FROM AUTHOR]

Background: Over the past years, there has been a growing concern that a considerable amount of anti-malarial supply in the underdeveloped world particularly in the private sector, is of poor quality. The World Health Organization (WHO) has received about 1500 reports that mentions instances of substandard and falsified products since 2013. The majority of the reports concerned antibiotics and anti-malarials. The majority of reports (42%) originate from the WHO African region. Objective: This study intends to assess the quality of the most widely used anti-malarial medications [artemether-lumefantrine tablets, chloroquine phosphate tablets, primaquine phosphate tablets, artesunate, and artemether injections] in Gambella, South-West, Ethiopia. Methods: A total of 52 samples were collected on June 2022 from Gambella National Regional State, Ethiopia. Half of the districts (six) located in the four zones of the region were chosen using simple random sampling technique. All drug retail outlets available in the selected districts (locally known as woredas) were included. The samples were subjected to visual inspection with a tool adopted from the joint WHO/FIP/ USP checklist. The pharmacopeial tests for identification, uniformity of dosage forms, assay, thickness, diameter, hardness, friability, disintegration test, dissolution, and sterility tests were carried out according to the USP 44-NF 39 and International Pharmacopoeia 11th edition, 2022 monographs. Results and Discussion: Only 25% of the samples were registered on the Ethiopian Food and Drug Authority (EFDA's) electronic regulatory/ registration system (ERIS). Besides, 88.8% of artemether injection products were presented in clear glass ampoules. This might expose the products to photochemical degradation that leads to in loss of anti-plasmodial activity. In addition, 50% of the artemether products assessed were not bioequivalent with the comparator product in the in vitro dissolution comparison tests. Overall, the study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. The stated percent of the samples had failed in one or more of the quality test parameters assessed in this study. Conclusion: The study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. Only a quarter were registered and 38% of the unregistered products failed the quality tests. Hence, the national, regional medicine regulatory bodies and other stake holders should perform the required roles to circumvent presence of Substandard and Falsified (SF) anti-malarial drugs in the study sites. [ABSTRACT FROM AUTHOR]

A sequential injection analysis method for the determination of glutathione (GSH) in pharmaceuticals has been developed. It is based on the reduction of the Cu(II)-neocuproine complex by GSH and the formation of an orange-yellow colored Cu(I)-neocuproine complex with maximum absorbance at 458 nm. Under optimal conditions the method is characterized by a linear calibration range of 6.0 × 10−7–8.0 × 10−5 mol L−1 (Amax = 3270 CGSH − 0.0010; R2 = 0.9983), limit of detection of 2.0 × 10−7 mol L−1, limit of quantification of 6.7 × 10−7 mol L−1, repeatability (expressed as relative standard deviation) of 3.8%, and sampling rate of 60 h−1. The newly developed method has been successfully applied to the determination of GSH in pharmaceutical samples with no statistically significant difference between the results obtained and those produced by the standard Pharmacopoeia method. [ABSTRACT FROM AUTHOR]

The field of oral drug delivery has witnessed significant advancements, with a focus on developing innovative formulations to address challenges associated with traditional dosage forms, especially for patients with difficulties in swallowing. Fast Dissolving Tablets (FDTs) have emerged as a promising class of tablets designed to rapidly disintegrate or dissolve in saliva, providing a convenient and patient-friendly alternative for various populations. This article explores the unique properties, advantages, and potential applications of FDTs, emphasizing their role in overcoming challenges posed by conventional oral drug delivery systems. FDTs offer rapid dissolution within 15-120 seconds in the buccal cavity, facilitating direct absorption through the buccal mucosa and ensuring quick therapeutic effects. This characteristic proves particularly beneficial for individuals facing swallowing challenges, such as pediatric and geriatric patients, or those with conditions like dysphagia. Recognizing the significance of FDTs, the European Pharmacopoeia (EP) has officially recognized them as “oral dissolving tablets," highlighting their acceptance in both academic and industrial settings. The article delves into the anatomical and physiological characteristics of the oral cavity, shedding light on the buccal epithelium, oral mucosa vascularization, and salivary flow, which play crucial roles in drug absorption. The ideal features of FDTs include rapid dissolution or disintegration, high drug load capacity, masking of bitter taste, positive mouth feel, ease of transport, and reduced sensitivity to environmental factors. The advantages of FDTs extend to their administration for patients unable to swallow, convenient treatment for bedridden and mobile patients, enhanced mouth feel and taste masking, ease of administration, and precise dosing. Despite their advantages, FDTs come with limitations, including issues related to mechanical strength, hygroscopic nature, brittleness, and challenges with bitter drugs or unpleasant odors. Overcoming these challenges requires a careful formulation approach to balance rapid disintegration with mechanical strength and taste masking. The article also discusses the salient characteristics of Fast Dissolving Dosage Forms (FDDDS) and various techniques for preparing FDTs, such as freeze-drying, tablet molding, and spray drying. Additionally, it explores the role of non-invasive drug delivery systems in addressing pharmaceutical industry needs, including improving drug half-life, solubility/stability, and bioavailability. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the anthelmintic activity of Lannea kerstingii and Ficus thonningii, on a nematode model, to promote their use in the Cameroonian pharmacopoeia for the treatment of helminthiases. Methods: One nematode was used, Heligmosomoides polygyrus. First, the effect of the extracts on the eggs and larval stages (L1, L2, and L3) of H. polygyrus was evaluated, 100 μL of extract and 100 μL of parasite suspension (containing 50 eggs) were mixed in a 96‐well microplate. The 96‐well microplate was incubated for 20 h at 25°C in the WMicroTracker which measures the motility of the worms at various concentrations. Finally, docking studies were conducted by using the Glide module in Schrodinger Maestro. Results: The ethanolic extract of L. kerstingii with the half maximal inhibitory concentration (IC50) of 0.1371 mg/mL produced a higher ovicidal effect than the effect produced by other extracts of these plants. However, with an IC50 of 0.31 mg/mL, the aqueous extract of F. thonningii showed the greatest effect on the L2 stage. The aqueous and ethanolic extracts of L. kerstingii and F. thonningii inhibited the development of the L3 larvae of H. polygyrus with a better effect for the ethanolic extracts. Conclusion: The use of L. kerstingii and F. thonningii for the treatment of helminthiasis has been proved in vitro and in silico by this research. However, more research is required, especially on the acute toxicity and in vivo anthelmintic efficacy to validate this scientific investigation. [ABSTRACT FROM AUTHOR]

Over the past two decades, diabetes pharmacopoeia has flourished, with new drugs that, on top of their glucose‐lowering efficacy, have been shown to protect the heart and the kidney. Despite these new opportunities, metformin retains a pivotal role among glucose‐lowering agents. As one of the few available insulin sensitizers, metformin is an effective, safe, and overall well‐tolerated drug backed by over 60 years of clinical experience, including evidence for potential benefits beyond glucose reduction across different ages, sexes, genetic backgrounds, geographical areas, and stages of disease. Although there is some discussion of whether metformin offers the most effective front‐line option in newly diagnosed type 2 diabetes (T2D), it remains a natural companion to all other glucose‐lowering agents. Furthermore, metformin comes at a very low cost and, as such, it has extremely high cost‐effectiveness, particularly given the serious economic burden associated with diabetes complications. This financial advantage is particularly relevant in resource‐constrained healthcare systems, where the affordability of metformin may be instrumental in implementing an effective treatment in an evergrowing number of individuals. We present here compelling real‐world evidence in support of the clinical efficacy and cost‐effectiveness of metformin across different patient populations, highlighting areas where more population‐based studies are needed to further incorporate and consolidate its use in the pharmacological management of T2D. [ABSTRACT FROM AUTHOR]

In order to improve and replace the enantiomer method outlined in the olodaterol hydrochloride draft monograph (From the European Pharmacopoeia forum), one new, simple, and fast enantioselective normal phase high‐performance liquid chromatography chiral method was developed on polysaccharide‐based Chiral MX (2) (4.6 × 250 mm, 5 μm) column. n‐Hexane, ethanol, and diethylamine in the ratio of 40:60:0.1 (V/V/V) were selected as mobile phase at a flow rate of 0.8 mL/min, and the detection was performed on a photodiode array detector at 225 nm with 5 μL injection volume. The column temperature was set at 40°C for better peak shape and sensitivity. The analysis time can be shortened to 15 min, whereas the resolution between enantiomer and olodaterol was found to be even more than 10.0, which was far better than that obtained with the reported method in this draft monograph. The developed chiral method was validated in accordance with ICH Q2 (R1), including specificity, LOD&LOQ, precision, linearity, accuracy, and robustness. Thereby, the proposed method was demonstrated to be suitable for the determination of enantiomer in olodaterol hydrochloride bulk drug and drug product. Besides, the thermodynamic parameters were evaluated on the basis of Van't Hoff plots that was used to explain correlative chiral recognition mechanisms with the chiral stationary phase. [ABSTRACT FROM AUTHOR]

Rationale: Perillae Fructus (PF) is a common traditional Chinese medicine (TCM) for the treatment of asthma. It has not been effectively characterized by rosmarinic acid (RosA), which is currently designed as the sole quality indicator in the Chinese Pharmacopoeia. Methods: This study introduced a database‐aided ultrahigh‐performance liquid chromatography equipped with quadrupole‐Exactive‐Orbitrap mass spectrometry (UHPLC/Q‐Exactive‐Orbitrap MS/MS) technology to putatively identify the compounds in PF, followed by literature research, quantum chemical calculation, and molecular docking to screen potential quality markers (Q‐markers) of PF. Results: A total of 27 compounds were putatively identified, 16 of which had not been previously found from PF. In particular, matrine, scopolamine, and RosA showed relatively high levels of content, stability, and drug‐likeness. They exhibited interactions with the asthma‐related target and demonstrated the TCM properties of PF. Conclusions: The database‐aided UHPLC/Q‐Exactive‐Orbitrap MS/MS can identify at least 27 compounds in PF. Of these, 16 compounds are unexpected, and three compounds (matrine, scopolamine, and RosA) should be considered anticounterfeiting pharmacopoeia Q‐markers of PF. [ABSTRACT FROM AUTHOR]

Background: One of the organisational strategies to ensure the use of relevant good practises for each stage in the life cycle of pharmaceutical products is the market surveillance program, which aims to demonstrate product specification adherence. It uses analytical pharmacopoeial and literature-based approaches primarily to carry out quality control on the chosen pharmaceutical items. Aim: Development of a program for analytical control of different medicinal products containing 25 mg hydrochlorothiazide. Materials and Methods: European Pharmacopoeia and USP HPLC methods for assay and related substances were applied in prescription medicines. Results: The system suitability tests were evaluated for each method, and the results of each generated group of products were compared. The quantitative content values deviation and the quantitative limitations for each impurity were determined. The deviations are in the range 0.76%-4.01%. Calculated RSD values are below 2%. The results obtained by both methods are within the acceptable limits of 95%-105%. In the European Pharmacopoeia method, the limits of three impurities were determined and seven more were found and marked as unknown. The USP method allows identification of only one impurity. Conclusion: For the market surveillance program for pharmaceuticals containing hydrochlorothiazide, an analytical control program has been developed. The program combines multiple pharmacopoeial HPLC methods and compares the outcomes with an initial assessment of each method's applicability for all pharmaceuticals containing hydrochlorothiazide. [ABSTRACT FROM AUTHOR]

A new, sensitive, and rapid isocratic reversed phase chromatographic method (RP-HPLC–UV) was developed for simultaneous separation of two newly co-formulated antiulcer mixtures; Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)], and Amoxicillin, Lansoprazole and Clarithromycin [Mixture (II)]. Analytical separation was performed using a Promosil C18 column and ultraviolet detection at 210 nm. The separation was achieved within only 8 min. For both mixtures, an aqueous solution, composed of (Acetonitrile: Methanol: 0. 2 M phosphoric acid) within ratio of (30: 30: 40) adjusted to final pH 3.0, was the mobile phase. This method was validated as per the International Conference on Harmonization guidelines. The linearity ranges of these proposed method of the (Mixture (I)) were 25.0–400.0 µg/mL Amoxicillin, 0.5–8.0 µg/mL Vonoprazan, and 12.5–200.0 µg/mL Clarithromycin. And the linearity ranges of the (Mixture (II)) were 10.0–300.0 µg/mL Amoxicillin, 0.3–9.0 µg/mL Lansoprazole and 5.0–150.0 µg/mL Clarithromycin. This method was firstly applied for effective separation of Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)]. It fulfilled good repeatability, sensitivity, and accuracy (R.S.D. < 2.0%). The mean recoveries of the analytes in their Tri-Pak formulations were acceptable. The greenness of the developed chromatographic methods was assessed using an Eco-scale method and it was applied for content uniformity testing as per the United States Pharmacopoeia (USP) and the acceptance value of Amoxicillin, in Mixture (I) was 2.88, the acceptance values for Amoxicillin, Lansoprazole in Mixture (II) were 2.592, 2.424, respectively. [ABSTRACT FROM AUTHOR]

Sariva is an important Ayurvedic drug designated to Hemidesmus indicus L. in Ayurvedic Pharmacopoeia of India. Roots of this plant are used either singly or as an ingredient in various Ayurvedic formulations and claimed to be useful in cough, fever, inflammation, gout, menorrhagia, blood purification, kidney and urinary disorders. Due to its high commercial demand, locals in different parts of India use few other species, namely, Ichnocarpus frutescens (L.) W. T. Aiton, Decalepis salicifolia Wight & Arn and, Cryptolepis buchanani Roem. & Schult. in name of Sariva. We carried out a comparative pharmacognostic evaluation of all the four species sold in name of Sariva to check the possible adulterants or substitute to the genuine one i.e., Hemidesmus indicus. These developed diagnostic (pharmacognostical) markers based on the physicochemical parameters and vanillin content will be useful in quality check for the bulk procurement by various herbal drug industries. [ABSTRACT FROM AUTHOR]

Atorvastatin (ATV) is a well-established lipid-lowering agent. ATV has two stereogenic centers, and of the four possible stereoisomers, only the (3R,5R) form is used therapeutically. The European Pharmacopoeia (EP) monograph 2022 for ATV calcium salt describes a normal-phase high-performance liquid chromatography (HPLC) method for the determination of enantiomeric purity in both drug substance and working standard samples, based on a 150 mm × 4.6 mm Chiralpak AD-H column. The main problems with this method are the very long analysis time and the high solvent consumption. Here, an alternative chromatographic protocol was developed using the Chiralpak AD-3 column (250 mm × 4.6 mm) packed with 3 μm silica particles instead of the 5 μm silica particles of the Chiralpak AD-H chiral stationary phase and characterized by the same polysaccharide selector, amylose-tris(3,5-dimethylphenylcarbamate). Using a mobile phase consisting of a mixture of n-hexane-ethanol-formic acid 90:10:0.1 (v/v/v) as the mobile phase and setting the flow rate and column temperature to 1.0 mL min−1 and 35 °C, respectively, a simultaneous stereo-selective separation was achieved within 35 min without observing any overlap between the enantiomeric impurity peak and peaks related to other ATV impurities. Compared to HPLC EP conditions, the analysis time to elute all the potentially related substances was faster and significantly less mobile phase volume was required. The linearity of the method has been demonstrated in the range of 4.4 μg mL−1 to 1000 μg mL−1 (R2 > 0.999). At a concentration of 4.4 μg mL−1, which is 0.075% of the test solution (5.8 mg mL−1, as ATV free acid), the signal-to-noise ratio was found to be 20. [ABSTRACT FROM AUTHOR]

The aim. To determine the optimal qualitative and quantitative composition of auxiliary substances for tablets containing dry extract of Acorus calamus leaves and the solid dispersion of quercetin, their relatively therapeutic dose and antiexudative activity. Materials and methods. This study determined a relatively therapeutic dose of dry extract of Acorus calamus leaves, investigated the impact of various auxiliary substances on the properties of tablets formulated with active ingredients -- dry extract of Acorus calamus leaves and solid dispersion of quercetin, and assessed antiexudative activity these tablets. The comprehensive analysis entailed the utilization of standardized pharmacopoeial methods to evaluate the quality of the tablet samples. These methods encompassed a range of assessments designed to ensure that the tablets met the requisite pharmacological standards, focusing on key characteristics such as dissolution rate and stability. Determination of the relatively therapeutic dose and antiexudative activity made using standard pharmacological methods in laboratory rats. Results. In-depth exploration during the study led to identifying Ac-Di-Sol and Lubripharm SSF as the most suitable auxiliary substances for the tablet composition. Detailed analysis revealed that Ac-Di-Sol, when utilized at a 10 % concentration, markedly improved the tablets' disintegration rate without adversely affecting their structural integrity. Concurrently, Lubripharm SSF was observed to significantly enhance the tablets' mechanical stability by reducing their friability. Conclusions. As a result of the study, the relatively therapeutic dose of dry extract of Acorus calamus leaves, and the solid dispersion of quercetin, optimal auxiliary substances for the tablet formulation -- Ac-Di-Sol and Lubripharm SSF -- were established. The conducted research enabled the development of a tablet composition that aligns with the requisite pharmacotechnological specifications and conditions of the modern pharmaceutical industry and demonstrates high antiexudative activity relative to monocomponent substances and famous drugs [ABSTRACT FROM AUTHOR]

The fruits of Amomum tsao-ko (Cao-Guo) were documented in Chinese Pharmacopoeia for the treatment of abdominal pain, vomiting, and plague. In our previous study, a series of diarylheptanes and flavonoids with α-glucosidase and protein tyrosine phosphatase 1B (PTP1B) inhibitory activity have been reported from the middle-polarity part of A. tsao-ko, whereas the antidiabetic potency of the low-polarity constituents is still unclear. In this study, three new hydroxytetradecenals, (2E, 4E, 8Z, 11Z)-6R-hydroxytetradeca-2,4,8,11-tetraenal (1), (2E, 4E, 8Z)-6R-hydroxytetradeca-2,4,8-trienal (2) and (2E, 4E)-6R-hydroxytetradeca-2,4-dienal (3) were obtained from the volatile oils of A. tsao-ko. The structures of compounds 1–3 were determined using spectroscopic data involving 1D and 2D nuclear magnetic resonance (NMR), high-resolution mass spectra (HRMS), and specific rotation ([α]D). Their hypoglycemic activity was evaluated against glycogen phosphorylase (GPa) and PTP1B. Compounds 1 and 2 displayed moderate activity against PTP1B with inhibition rates of 33.8%−50.3% at 100 and 200 µM. Moreover, compound 1 exhibited an obvious inhibitory effect on GPa (IC50 = 31.7 µM), whereas compound 2 was inactive. This study demonstrates hydroxytetradecenals as the characteristic components of A. tsao-ko with therapeutic potential in diabetes. [ABSTRACT FROM AUTHOR]

Drug impurity profile studies have changed significantly during the past ten years, as demonstrated by pharmacopeia and regulatory standards. This review article aims to give viewers a thorough understanding of the numerous facts of impurity profiling in relation to regulatory criteria. Comprehensive information on residual solvents, water impurities, elemental impurities, carcinogenicity and an overview of the most critical components of genotoxic contaminants. To ensure the drug products fulfill the minimal acceptable quality standards and a number of pharmacopoeias have created monographs. ICH, EMEA, USFDA and European Pharmacopeia recommendations are just a few of the regulatory bodies that offer rules to reduce the amount of contaminants in medications. In order to prevent impurities, industry, research and development sectors widely employ different spectrum analyses including HPLC, LC/MS and GC/MS. It involves the recall of medications because of these contaminants. The significance of understanding genotoxic impurities as a crucial element of the impurity profile in medications is emphasized in this abstract. [ABSTRACT FROM AUTHOR]

For a solid understanding of drug characteristics, in vitro measurement of the intrinsic dissolution rate is important. Hydrodynamics are often emphasized as the decisive parameter influencing the dissolution. In this study, experiments and computational fluid dynamic (CFD) simulations showed that the mixing behavior in the rotating disc apparatus causes an inhomogeneous flow field and a systematic error in the calculation of the intrinsic dissolution rate. This error is affected by both the experimental time and the velocity. Due to the rotational movement around the tablet center, commonly utilized in pharmacopeia methods, a broad variance is present with regard to the impact of fluid velocity on individual particles of the specimen surface. As this is significantly reduced in the case of uniform overflow, the flow channel is recommended for investigating the dissolution behavior. It is shown that rotating disc measurements can be compared with flow channel measurements after adjusting the measured data for the rotating disc based on a proposed, representative Reynolds number and a suggested apparatus-dependent correction factor. Additionally, modeling the apparatus-independent intrinsic dissolution rate for different temperatures in the rotating disc apparatus is possible using the adapted Levich's equation. [ABSTRACT FROM AUTHOR]

Naodesheng Tablet (Naodesheng Pian), a traditional Chinese medicine formula for stroke treatment, is made up of five herbal medicines, i.e., Sanqi, Gegen, Honghua, Shanzha, and Chuanxiong. However, the current Pharmacopoeia quality-marker (Q-marker) system cannot detect possible adulteration. Our study tried to use a new strategy, i.e., standards-library-dependent ultra-high-performance liquid chromatography-quadrupole-Orbitrap mass spectrometry (UHPLC-Q-Orbitrap MS/MS) putative identification, to reconstruct the Q-marker system. Through the strategy, 30 isomers were successfully differentiated (such as 2′-hydroxygenistein, luteolin, and kaempferol; ginsenoside Rg2 and ginsenoside Rg3; ginsenoside Rf and ginsenoside Rg1). In particular, 11 compounds were unexpectedly found in Naodesheng, including 2′-hydroxygenistein, 7,4′-dihydroxyflavone, pectolinarigenin, 7-methoxy-4′-hydroxyisoflavone, scoparone, matrine, 3,3′,4′,5,6,7,8-heptamethoxyflavone, 5-hydroxyflavone, diosgenin, chloesteryl acetate, and (+)-4-cholesten-3-one. In total, 68 compounds were putatively identified and fully elucidated for their MS spectra. Subsequently, relevant compounds were further investigated using UV-vis scanning experiments, semi-quantitative analysis, and quantum chemical calculation. Finally, five adulterated Naodesheng Tablets were used for validation experiments. The experiment successfully detected five adulterated ones via a lower-version LC-MS analysis. On this basis, three new candidates (hydroxy safflor yellow A (HSYA), citric acid, and levistilide A), along with puerarin and notoginsenoside R1, are re-nominated as the Q-markers for LC-MS analysis. The LC-MS analysis of puerarin, notoginsenoside R1, HSYA, citric acid, and levistilide A can clearly detect adulteration regarding all five herbal medicines mentioned above. Therefore, the reconstructed Q-markers are described as a "perfect" quality control system to detect adulteration in Naodesheng and will offer a valuable recommendation for the Pharmacopoeia Commission. [ABSTRACT FROM AUTHOR]

From the first self-medications in the Paleolithic era to modern vacuum extractions, plant essences have always been part of the human pharmacopoeia. This article retraces the various stages that led to the emergence of Aromatherapy, from the use of aromatic plants by the first civilizations, to its evolution in line with technological development, particularly that of the alembic, to its current expansion and its various therapeutic applications. [ABSTRACT FROM AUTHOR]

Russian and foreign pharmacopoeias require at least two stages in the manufacturing process of medicinal products based on animal serum-plasma to provide at least a 4-log decrease in the concentration of extraneous viruses to minimize the risk of viral contamination in the corresponding intermediates after each stage. The enzymolysis and thermal denaturation stages involved in the production of drugs based on equine blood plasma were validated for reduction of model enveloped viruses in influenza (RNA-containing) and smallpox vaccine (DNA-containing). Both stages were shown to provide the required level of inactivation of these model viruses in the corresponding drug intermediates, significantly minimizing the risk of their contamination with enveloped viruses. [ABSTRACT FROM AUTHOR]

Background Through the recent development of analytical technology, antibiotics quantification in the Japanese Pharmacopoeia (JP) has changed from traditional microbiological assays to physicochemical methods with high specificity and precision. However, for several multicomponent antibiotics without typical UV absorption, potency cannot be directly determined using instrumental methods such as high-performance liquid chromatography; therefore, traditional microbiological assays are still used. Gentamicin sulfate (GmS), which consists of three major components, C1, C1a, and C2, is such a typical antibiotic, and its antimicrobial potency continues to be assayed using microbiological methods in JP monographs. Introduction of a physicochemical assay for GmS is needed to help ensure its quality and quantity. Objective This study aimed to develop quality control measures for GmS that could be complementary to quantitative assays and purity tests specified in the JP. Methods For each gentamicin C component (C1, C2, and C1a), theoretical potencies were determined based on the quantitative relationship between purity and potency, as measured by quantitative 1H NMR and microbiological assays, respectively. Two lots of the JP reference standard (RS) were used as test samples, with the contents of each component and impurity (sisomicin and garamine) being determined using hydrophilic interaction liquid chromatography–tandem mass spectrometry (HILIC-MS/MS). Results The ratios of theoretical potency for C1, C2, and C1a were 1.00, 1.21, and 1.80, respectively. The potencies of the GmS JP RSs, which were estimated based on the contents and theoretical potency of each C component, corresponded well with those determined through microbiological assays. Marked differences in impurities (%) between the two RS lots were highlighted by quantifying sisomicin and garamine. Conclusions The developed analytical procedure enabled the characterization of two different JP RSs in terms of content ratio, potencies, and impurities. Highlights Novel analytical procedures useful for routine quality control of GmS were developed using HILIC-MS/MS. [ABSTRACT FROM AUTHOR]

Aim: The purpose of the study was development and evaluation of Atenolol loaded microsponge in situ gel for the management of ocular hypertension, glaucoma. Materials and Methods: The microsponges were prepared by modified oil in oil emulsion solvent diffusion method. The polymers used for fabrication of microsponges include Ethyl Cellulose and Eudtagit RL-100. Results: The results of particle reveals that the particle size varies from 7.33 to 9.76µm, percentage yield ranges from 59.98 to 81.22, entrapment efficiency (%) 58.23 to 80.56 and drug content (%) varies from 54.12 to 82.89. Further, the microsponges were loaded in in situ gel. The in situ gel was fabricated by using Poloxamer 407 and HPMC K4M polymers. The microsponges loaded in situ gel was evaluated for different parameters like pH, viscosity, gelling capacity, gelation temperature and drug release study. The pH varies from 6.83 to 7.43, viscosity ranges from 7421 to 15623 cp, gelation temperature ranges from 37.14 to38.22°C while the drug release ranges from 62.52 to 83.32%. At last, the stability study report indicated that the developed drug loaded microsponge in situ gel were physically and chemically stable over a period of three months. Sterility testing was conducted in the optimized formulations as per Indian Pharmacopoeia. The studies reveal that there was no sign of growth of microorganism. Conclusion: Atenolol loaded microsponge loaded in situ gel can effectively treat Glaucoma and improve the patient compliance. [ABSTRACT FROM AUTHOR]

The medical armamentarium of the 15th century had a very strong reliance to plant products that were often identified as useful by a trial-and-error experimentation process. The corpus of experiential knowledge was passed on by word of mouth from one generation to the next until formal pharmacopoeias in the form of herbals were published. Another form of generational transmission was to etch the time-acquired knowledge in stone. The foliage carved on the Burton Lazar [Leicestershire, England) leprosarium stonework may have been one example of a medical herbal etched in stone. [ABSTRACT FROM AUTHOR]

The catalytic oxidation reaction between Coomassie Brilliant Blue and N-bromosuccinimide was used in an acidic medium to develop a spectrophotometric method for the estimation of dopamine and methyldopa in their pure forms and in pharmaceutical preparations. The developed method exhibited high sensitivity, with molar absorptivity values of 1.77 × 104 and 2.97 × 104 L mol-1 cm-1, and Sandell's sensitivity values of 0.0080 and 0.0107 mg cm-2, respectively. The estimated quantities of dopamine hydrochloride and methyldopa were within the range of 0.5-18 μg/mL and 0.5-13 μg/mL, respectively. The developed method was successfully applied to tablet and injection formulations, and the results were in accord with the original drug content. The developed method was compared with standard addition and standard method in the British Pharmacopoeia, and no significant differences were revealed thus confirming the success of the developed method in the estimation of the studied drugs. Other statistical values were also studied . [ABSTRACT FROM AUTHOR]

Essential oils, although they are effective due to the compounds they contain, are usually high-cost products that are obtained with low efficiency and have stability problems. Many of these oils, which can be found at various prices on the market and are claimed to be natural by manufacturers, are adulterated with other oils or synthetic substances. This study aims to provide samples of the essential oils, which are used in public, namely clove, neroli, tea tree, and cinnamon essential oils belonging to brands known to be sold widely on the market and to evaluate the compliance of these oils with the pharmacopoeia by conducting pharmacopoeia analysis. Among 25 essential oil samples evaluated with reference to the Turkish Pharmacopoeia (2017) within the scope of the study, only 2 of them were found to comply with the pharmacopoeia in terms of all tests. Investigating the compliance of essential oils with quality criteria is of great importance in preventing harm to the health of consumers and preventing them from purchasing unqualified products. [ABSTRACT FROM AUTHOR]

As wild Aquilaria sinensis resources are exhausted and protected, China has established a huge number of plantations of Aquilaria trees and developed artificial induction techniques. However, the current output and quality of artificial induction technology have not yet met the expected results. It has been found that high-oil-containing agarwood may contain particular fungal stains associated with agarwood production. To enhance the quality of agarwood, we recovered and characterized three highly active fungi from high-oil-containing agarwood and inoculated them onto A. sinensis trees using two traditional physical methods. The results showed that fungi extracted from high-oil-containing agarwood can effectively increase the yield and quality of agarwood. During the agarwood formation process, parenchyma cells, xylem rays, and axial parenchyma cells in the xylem gradually undergo apoptosis, thereby promoting the expansion of the color range of agarwood. Nine months after the treatment, the alcohol-soluble extract content in agarwood reached the standard specified in the Chinese Pharmacopoeia (10%), and the proportions of sesquiterpenes and chromones in each treatment were 55.82%, 58.31%, 62.65%, 70.97%, and 13.71%, respectively. These results indicate that fungal induction has a positive impact on the quality of agarwood. In addition, compared to drilling and fungus combined induction, "burning holes and fungi" combined induction demonstrates better results and can further improve the yield and quality of agarwood. [ABSTRACT FROM AUTHOR]

The aim. This study aimed to evaluate the completeness of our knowledge about the sources of variation in the Dissolution test with 100 % release by compiling a variability budget. Materials and methods. The study was performed on 500 mg metformin tablets, using pharmacopoeial quality reagents, State Pharmacopoeia of Ukraine (SPhU) Metformin HCl reference standard, Pharmatest DT70 Dissolution apparatus, Perkin Elmer Lambda 35 spectrophotometer, Mettler Toledo XP 204 analytical balance, and ISO class A volumetric glassware. The SPhU metrological approach was employed. Results and discussion. The variability budget was compiled based on the comparison of uncertainty estimates obtained from the requirements for maximum permissible variation in normal analytical practice (UNAP, bottom-up estimation) and experimental data (Uexp). This involved characterizing Metformin content in tablets using the Uniformity of Dosage Units (UDU) test as an independent method. The 100 % release of Metformin in the Dissolution test (infinity point) was proved by increasing the dissolution time. Having optimized Dissolution and UDU analytical procedures for variability budget compiling, we achieved insignificance of Uexp compared to the target uncertainty (Utg) for the Dissolution test in compliance testing. The differences in UDU and Dissolution mean results did not exceed UNAP for the release time of 45 and 60 min, i.e. uncertainty budget was proven. Uexp for the Dissolution test indicated the presence of an unknown statistically significant source of random variation, which, however, was less than Utg; therefore, the procedure is suitable for compliance testing. Conclusion. Experimental results confirmed the completeness of our knowledge about sources of variation (absence of bias) for the Dissolution test with 100 % release. An essential condition for compiling the budget was the optimization of uncertainty of analytical procedures. For UDU, all significant sources of variation were within the expected range. Yet, there is a need for additional research to identify and manage an unknown source of practically significant random variation for the Dissolution test. [ABSTRACT FROM AUTHOR]

Copyright of Revista Foco (Interdisciplinary Studies Journal) is the property of Revista Foco and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In this research, whole process of small-scale and pilot-scale carrier-free 177Lu production have been developed and curie-level 177Lu was achieved. Additionally, the methodology of product key quality control inspection has been developed and verified, the control standard has been established. Key indicators of the product have met or exceeded the requirements of the European Pharmacopoeia. Up to date, about 30 Ci carrier-free 177Lu product has been obtained based on this development. The carrier-free 177Lu obtained in this research has been used in nearly 20 trial parties including units for drug R & D and clinical research. [ABSTRACT FROM AUTHOR]

[Objectives] To establish a method for quality analysis of Medicine Pileostegia tomentella Hand. -Mazz. [Methods] According to the testing method of Chinese Pharmacopoeia (2020 Edition), the water content, total ash and alcohol-soluble extract of P. tomentella Hand. -Mazz. were determined. [Results] 10 batches of P. tomentella Hand. -Mazz. from different habitats and in different collection time in Guan- gxi all had the same plant morphology and medicinal properties. The experimental results showed that the water content was 7.92%-10.35%, the total ash content was 5.53% -6.62%, the acid-insoluble ash content was 0.59%-0.76%, and the extract content was 11.63%-16.12%. [Conclusions] The identification method in this study can be used for the quality analysis of P. tomentella Hand. -Mazz., and the experimen- tal results can provide a scientific basis for the development and utilization of P. tomentella Hand. -Mazz. and the establishment of its quality standard. [ABSTRACT FROM AUTHOR]

The article deals with blood collection by naturopaths for the production of autologous blood products. It is pointed out that the requirement for a doctor's involvement in blood donation applies to both native autologous blood treatment and treatment with homeopathic and/or non-prescription finished medicinal products. The exception for homeopathic autologous blood products does not apply because they are not produced according to the procedures described in the European Pharmacopoeia or the officially recognized pharmacopoeias of EU member states. It is stated that the clinic does not carry out blood collection under the responsibility of a medical person or using telemedicine procedures. The prohibition of blood collection for the production of autologous blood products is considered lawful. [Extracted from the article]

Background: 177Lu-radiopharmaceuticals can contain the metastable impurity [177mLu]lutetium with a physical half-life of 160.4 days, in varying concentrations depending on the route of production of the radionuclidic precursor [177Lu]lutetium. Due to the long half-life of [177mLu]lutetium, difficulties with waste disposal or sterility testing could arise. Here, we analyzed several 177Lu-samples of different origins and suppliers regarding their 177mLu-concentration. Results: All samples tested showed a 177mLu-concentration in the range that was stated on the certificate of analysis from the supplier which is in accordance with the European Pharmacopoeia. Conclusions: Although all 177mLu-concentrations were in accordance with the European Pharmacopoeia, we need to take into account the respective national legislation regarding radioactivity release limits. With regard to the German legislation, several probes for sterility testing in external laboratories could not be released for transport due to the concentration of [177mLu]lutetium. Moreover, waste water tanks should specifically be monitored for 177mLu-concentration, when e.g. Lutathera® is administered in the clinic. [ABSTRACT FROM AUTHOR]

Background: 177Lu-radiopharmaceuticals can contain the metastable impurity [177mLu]lutetium with a physical half-life of 160.4 days, in varying concentrations depending on the route of production of the radionuclidic precursor [177Lu]lutetium. Due to the long half-life of [177mLu]lutetium, difficulties with waste disposal or sterility testing could arise. Here, we analyzed several 177Lu-samples of different origins and suppliers regarding their 177mLu-concentration. Results: All samples tested showed a 177mLu-concentration in the range that was stated on the certificate of analysis from the supplier which is in accordance with the European Pharmacopoeia. Conclusions: Although all 177mLu-concentrations were in accordance with the European Pharmacopoeia, we need to take into account the respective national legislation regarding radioactivity release limits. With regard to the German legislation, several probes for sterility testing in external laboratories could not be released for transport due to the concentration of [177mLu]lutetium. Moreover, waste water tanks should specifically be monitored for 177mLu-concentration, when e.g. Lutathera® is administered in the clinic. [ABSTRACT FROM AUTHOR]

A technique for encapsulating the anti-inflammatory dodecapeptide ingramon into microspheres of a biodegradable copolymer of lactic and glycolic acids (PLGA) to provide prolonged release of the peptide for up to 28 d is presented. The technique makes it possible to achieve >90% encapsulation efficiency and is suitable for producing an injectable suspension that meets the requirements of the State Pharmacopoeia of the Russian Federation. The peptide distribution inside the obtained microspheres and its release kinetics were characterized. A tendency toward suppression of JE/CCL2-dependent monocyte migration was revealed in mice with preliminary (7 d before the experiment) administration of ingramon-depot. [ABSTRACT FROM AUTHOR]

Pharmacists are the main unit that provides medicines to the population. Currently, a serious problem that occurs in Bulgaria and on a global scale, is the lack of basic medicines. Patients' access to medicinal products is hampered by the lack of pharmacies located in small towns, round-the-clock pharmacies or pharmacies being able to prepare magisterial or pharmacopoeia recipes. The study aims to analyse the problems with the greatest impact on the deterioration of the population's access to medicinal products and pharmaceutical services. Materials and methods: To achieve the goal of the study, a direct anonymous survey was conducted among master pharmacists practicing in community pharmacies on the territory of the city of Varna. Results: The most pressing problem in the pharmaceutical sector is the shortage of drugs in the pharmacy network, as indicated by 61 (48%) of the surveyed persons. The next issue is access to pharmaceutical services in small settlements. It was reported by 56 (44%) of respondents, but a large percentage of pharmacists, 62(49%), indicated that they would work in a small town for a motivating salary. A small percentage, 24(19%), of pharmacists indicated that the problem with 24/7 pharmacies exists, with a large proportion of respondents, 91(72%), not willing to work night shifts. The smallest number of respondents, 18 (14%), indicated as a problem the lack of pharmacies preparing medicinal forms according to the magistral and pharmacopeial prescription. Conclusion: Pharmacists have to work to provide medicines for all patients. The subjects would work for motivating pay in small towns but would not engage in a night shift schedule. [ABSTRACT FROM AUTHOR]

The pharmacist is the most accessible healthcare provider. The even distribution of pharmacies throughout the country is an important factor for ensuring patients’ access to pharmaceutical care. Aim: The study aims to track the distribution of community pharmacies and patients’ access to specific pharmaceutical activities by territorial areas in Bulgaria. Materials and methods: Public registers of the Bulgarian Drug Agency, the Ministry of Health, Regional Health Inspectorates, the National Health Insurance Fund, Bulgarian Pharmaceutical Union are analyzed. The survey is conducted for the period of June-August 2022. Results: In Bulgaria there are 3309 pharmacies, unevenly distributed by territorial areas. On average, one pharmacy is served by 2.11 pharmacists. At the national level, 68 % of the pharmacies have a contract to work with the NHIF. Only 13 % of the pharmacies have permission to prepare medicinal products according to the magisterial recipe and pharmacopoeia recipe. An active license to work with narcotic substances is established at 55% of the pharmacies in the 10 regions of the country studied. The еstablished uneven territorial distribution of the offered pharmaceutical activities may lead to difficulties according to patients’ access. [ABSTRACT FROM AUTHOR]

In this study, we established a new rapid, simple and low cost method for the determination of coumarin components in Angelica dahurica using high-performance thin-layer chromatography (HPTLC) based on the standards of the Chinese Pharmacopoeia for the analysis of isoimperatorin, imperatorin, oxypeucedanin, xanthotoxol and byakangelicin. The coumarins in A. dahurica were extracted with solvent methods, and linear ascending development was carried out in a twin trough glass chamber saturated with petroleum ether-ethyl acetate (3:2, v/v). The plate was dried and analyzed by HPTLC scanner at 254 nm. The five coumarin components have achieved good separation, clear and satisfactory resolution with the Rf values of 0.84, 0.69, 0.64, 0.57 and 0.19 for isoimperatorin, imperatorin, oxypeucedanin, xanthotoxol and byakangelicin, respectively. The content of five coumarins were 0.282, 0.626, 0.393, 0.066 and 0.144, respectively. In addition, the calibration range was constructed in the range 0.8-4.0 μg/spot; the limit of detection and limit of quantification, precision, repeatability and recovery were stably and good. This study indicated that the HPTLC scanning could be used for the determination of multiple components in A. dahurica. [ABSTRACT FROM AUTHOR]

Jatropha multifida L., a plant from the Euphorbiaceae family, is commonly used in Benin's traditional medicine due to its therapeutic benefits. This study aims to explore the medicinal efficacy of Jatropha multifida L. by evaluating its various biological activities. An initial phytochemical analysis was conducted, following which the polyphenols and flavonoids were quantified and identified using LC-MS-ESI. The antimicrobial efficacy of the extracts was tested using agar diffusion. Their antioxidant capacity was assessed using several methods: DPPH radical reduction, ABTS radical cation reduction, ferric ion (FRAP) reduction, and lipid peroxidation (LPO). Anti-inflammatory activity was determined based on the inhibition of protein (specifically albumin) denaturation. The study identified several phenolic and flavonoid compounds, including 2-Hydroxybenzoic acid, o-Coumaroylquinic acid, Apigenin-apiosyl-glucoside, and luteolin-galactoside. Notably, the extracts of J. multifida demonstrated bactericidal effects against a range of pathogens, with Concentration Minimally Bactericidal (CMB) values ranging from 22.67 mg/mL (for organisms such as S. aureus and C. albicans) to 47.61 mg/mL (for E. coli). Among the extracts, the ethanolic variant displayed the most potent DPPH radical scavenging activity, with an IC50 value of 0.72 ± 0.03 mg/mL. In contrast, the methanolic extract was superior in ferric ion reduction, registering 46.23 ± 1.10 µgEAA/g. Interestingly, the water-ethanolic extract surpassed others in the ABTS reduction method with a score of 0.49 ± 0.11 mol ET/g and also showcased the highest albumin denaturation inhibition rate of 97.31 ± 0.35% at a concentration of 1000 µg/mL. In conclusion, the extracts of Jatropha multifida L. are enriched with bioactive compounds that exhibit significant biological activities, underscoring their therapeutic potential. [ABSTRACT FROM AUTHOR]

The Manchu edition of Si yang-ni okto-i bithe 西洋藥書 (the Book of Western Medicine) was supposedly written by the missionaries Joachim Bouvet (1656-1730) and Jean-François Gerbillon (1654-1707) during Kangxi's 康熙 reign. Limited by their language capabilities, it was difficult for scholars in the past to know what knowledge the book introduced and whether or not it was Western knowledge. This article analyzes transliterated vocabularies in the work to explore its strategies for introducing knowledge. Most of these vocabularies are found in prescription formulas called eliksir. Tracing the sources of these vocabularies one by one, this article finds that the eliksir formula's effects, ingredients, and writing styles correspond to those used in European pharmacopoeia such as The Royal Pharmacopoea, Galenical and Chymical referenced by Bouvet. Moreover, these formulas were based on Western pharmacology, but the book introduces medicinal effects without mentioning related pharmacological knowledge. Accordingly, it can be speculated that the author of the Book of Western Medicine read Latin with a French accent, and that the Jesuits did not want to link the elixirs to China's immortality medicines. These formulas may have been a carefully designed proposal, where the Jesuits deliberately selected famous medicines from European pharmacopeias to arouse the curiosity and interest of Emperor Kangxi; however, the medicines may not have been actually produced. The transliteration strategy may have helped French Jesuits emerge victorious in their competition with Portuguese Jesuits, but its effectiveness in the exchange of knowledge may have been limited. [ABSTRACT FROM AUTHOR]

Systemic sclerosis (SSc) is a systemic disease encompassing autoimmunity, vasculopathy, and fibrosis. SSc is still burdened by high mortality and morbidity rates. Recent advances in understanding the pathogenesis of SSc have identified novel potential therapeutic targets. Several clinical trials have been subsequently designed to evaluate the efficacy of a number of new drugs. The aim of this review is to provide clinicians with useful information about these novel molecules. In this narrative review, we summarize the available evidence regarding the most promising targeted therapies currently under investigation for the treatment of SSc. These medications include kinase inhibitors, B-cell depleting agents, and interleukin inhibitors. Over the next five years, several new, targeted drugs will be introduced in clinical practice for the treatment of SSc. Such pharmacological agents will expand the existing pharmacopoeia and enable a more personalized and effective approach to patients with SSc. Thus, it will not only possible to target a specific disease domain, but also different stages of the disease. [ABSTRACT FROM AUTHOR]

Mimicking the lung environment has always been a challenge with regards to dissolution testing of inhaled drugs from dry powder inhalers (DPIs). The aim of this review is to critically appraise the literature currently available on the in vitro test methods for dissolution of orally inhaled drug particulates. Reasons for the lack of standardised testing methods are discussed. Currently, there is not one test that fully represents the situation that occurs in the lungs in vivo, and this is the reason for the lack of a dissolution test recommendation by the pharmacopoeia. The importance of dose collection as a prerequisite to dissolution testing is also discussed using the Andersen cascade impactor as an example. Moreover, a study was carried out to determine the most robust method for testing the dissolution of fluticasone. Three different testing methods were used, i.e., the Transwell system, the paddle-over-disk method and DissolvIt. The results of this study determined that the paddle-over-disk method had the fastest dissolution rate. However, the data showed that there was a lack of similarity between all three tests. This lack of similarity between dissolution methods contributes to the reason why there is no standardised recommended dissolution method listed in the pharmacopoeia. Whilst the paddle-over-disk method yielded the fastest dissolution rate, it does not mean that it is reflective of in vivo dissolution. [ABSTRACT FROM AUTHOR]

Objectives: Various pure rosemary essential oil containing commercial products are in demand for their health-promoting and cosmetic claims in Türkiye. Although they are natural and harmless, they should be in compliance with European Pharmacopoeia (EP) criteria. Therefore, in this study, 15 rosemary oil samples sold in pharmacies, herbal shops, and online platforms in Türkiye were investigated in terms of "Rosemary Oil" EP 10.0. monograph criteria. In the current study, we aimed to evaluate the current quality status of rosemary essential oils in the Turkish market. Materials and Methods: Appearance, fatty oils and resinified essential oils, relative density, refractive index, optical rotation, and acid value tests were performed according to EP 10.0 and compared with the given standards. In addition, thin layer chromatography (TLC) and gas chromatography-mass spectrometry (GC-MS) analysis were conducted on all samples for advanced understanding of their phytochemical profile and harmony with EP standards. Results: Fifteen pure rosemary oil-containing products from the Turkish market were evaluated. All of the samples were licensed as cosmetic products in Türkiye via the Ministry of Health. 83.1 to 96.9% of the ingredients of all samples were determined via GC-MS analysis. Results demonstrated that none of the samples from the Turkish rosemary essential oil market fully complied with the EP rosemary oil monograph standards. Conclusion: Considering our data, it was revealed that enhanced regulations and auditing mechanisms are needed to improve the quality of products. When the difference between the sources of purchase is assessed, pharmacies are still better locations to obtain such products. [ABSTRACT FROM AUTHOR]

Using an in vitro dissolving research, compare the pharmacological equivalent of three brands of Shatavari tablets sold in India. According to IP rules, the dissolution was performed using apparatus I (the paddle device). According to the Indian Pharmacopoeia, evaluation of physicochemical characteristics including weight variation test, content uniformity test, hardness test, friability test, disintegration test, and dissolution test was conducted. For weight fluctuation, content homogeneity, hardness, friability, disintegration time, and dissolving study, all brands complied with official specifications. Two out of the three brands of Shatavari tablets achieved more than 75% dissolve in just 60 minutes, according to the dissolution profile. Out of three brands of Shatavari tablets, the results indicated that two of them had satisfactory quality and had passed all of the pharmacopoeia's tests. [ABSTRACT FROM AUTHOR]

The emergence of multidrug bacterial resistance poses a great public health problem and requires a constant search for new antibacterial agents. However, Niger's flora possesses several medicinal plants used in traditional medicine to cure infectious diseases and can be used as sources of bioactive ingredients. This current study was designed to evaluate the antibacterial activity of eight plants used in the traditional pharmacopeia of Niger. The extracts were prepared by maceration using ethanol, methanol, and distilled water. The obtained extracts were screened against Salmonella spp., Shigella spp., and Escherichia coli using the microdilution method coupled with a resazurin-based assay. Phytochemical screening was performed using colorimetry, while the quantification of total polyphenols, total flavonoids, and total tannins was determined by spectrophotometry. Out of the eight plants obtained, five named Cassia italica, Limeum pterocarpum, Phyllanthus pentandrus, Strychnos innocua, and Ximenia americanum exhibited antibacterial activity with MICs ranging from 500 μg/mL to 2000 μg/mL. Phytochemical screening showed the presence of alkaloids, saponosides, tannins, flavonoids, terpenes/sterols, quinones, and polyphenols. The ethanolic and methanolic extracts of X. americana contained important quantities of total polyphenols, with 43.59 ± 0.15 and 41.97 ± 0.02 mg EAG/100 mg of extract, respectively. These extracts showed the highest contents of total tannins at 46.49 g/L and 45.52 g/L, respectively. For total flavonoids, the highest content was obtained with the methanolic extract of P. pentandrus, with 3.12 ± 0.01 mg QE/100 mg of extract. These findings justify the uses of these plants in traditional medicine for the treatment of infectious diseases such as diarrhea and can be used as starting points for the development of phytodrugs against infectious diarrhea. [ABSTRACT FROM AUTHOR]

For the first time, an UPLC-QTOF-MS method was developed and validated to simultaneously estimate dronedarone (DDN) and its four unlisted pharmacopoeial impurities: DDN impurities A, B, C, and D. UPLC separation was performed for 6 min on a BEH C18 (50 × 2.1 mm, 1.7 µm) columnwith 0.1% formic acid in water (A) and acetonitrile (B) as mobile phase delivered in gradient at a constant flow rate of 0.6 mL/min. Mass spectrometric detection was performed in ESI-QTOF-MS. The LOD and LOQ values for the analytes ranged from 0.5 to 10 and 0.8 to 75 ng/mL, respectively. The method was found to be linear for all analyte ranges with r2 values ≥0.9998. The method was precise with %RSD values ≤6.5% and overall analyte recovery was found to be 99.8 ± 1.0%. A novel, sensitive, selective, specific, linear, and accurate UPLC-QTOF-MS method was developed and validated to simultaneously estimate DDN and its impurities which are not listed in the pharmacopoeia. [ABSTRACT FROM AUTHOR]

In this study, five treatments were conducted to determine effect of humic acid conditioners on the growth traits and quality of Codonopsis pilosula, the treatments were plant growth conditioner farmers are used to applying(CK), pure water (T0), humic acid conditioner I(T1), humic acid conditioner II(T2) and humic acid conditioner I + root-promoting growth conditioner(T3), and comprehensive evaluation was conducted through the membership function method to determine the humic acid conditioner the most most suitable for Codonopsis pilosula. The results showed that after spraying different types of humic acid conditioners, the root length of T3 treatment was the largest, which was significantly increased by 7.73% and 6.83% compared with T0 and T1 treatments. The potassium accumulation of T0 treatment was significantly lower than that of the other treatments, which was 18.13%, 9.18%, 13.03%, and 16.48% lower than that of CK, T1, T2, and T3, respectively. The yield of T1, T2, and T3 treatments was significantly higher yields than that of the T0 treatment, and there was no significant difference in the yield between T3 and CK, the yield under T3 was increased by 19.74% compared with T0. The content of moisture, total ash and extract of Codonopsis pilosula reached the standard of the Chinese Pharmacopoeia(2020 edition). The content of polysaccharide and lobetyolin under T3 was significantly increased by 49.97% and 78.95% compared with CK, respectively, and the value was significantly increased by 25.25% and 30.77% compared with T0, respectively. Humic acid conditioner I + root-promoting growth conditioner had the best effects on increasing the yield and simultaneously improving quality of Codonopsis pilosula by the comprehensive evaluation based on membership function method. [ABSTRACT FROM AUTHOR]

Introduction: Quality, safety, and efficacy are the three main components of any therapy used for disease cure. Ayurveda encompasses vast knowledge regarding the use of numerous herbal sources for disease management. Sphaeranthus indicus Linn. (Known as Mundi) is one such drug praised in classical as well as contemporary medicinal science for its therapeutic efficacy. The present study aims at development of quality standards for the Sphaeranthus indicus Linn. (Whole plant) sample utilizing physico-chemical and phytochemical analysis. Objectives: To perform physico-chemical, phytochemical, HPTLC, FTIR and UV analysis of Sphaeranthus indicus Linn (Whole plant) sample. Materials and Methods: Physico-chemical analysis was done as per the guidelines mentioned by Ayurvedic Pharmacopoeia of India. Phytochemical analysis, HPTLC, FTIR and UV analysis was done as per the globally accepted standard guidelines. Observations and Results: The observed values were then compared to the standard values to make the monograph of Sphaeranthus indicus Linn. (Whole Plant). [ABSTRACT FROM AUTHOR]

Eucalyptus oil is prominent for its health-promoting and cosmetic utilizations. Thus, pure eucalyptus oil containing products are abundant in Turkish market. Natural products may be regarded as safe however, it is only accurate if the accessible products meet the international quality criteria. Türkiye is legally bounded to European Pharmacopoeia (EP) and there are various monographs for herbal products, including eucalyptus oil. Hence, for this study 16 eucalyptus oil samples obtained from different sources were investigated for their compliance with latest version of EP. Appearance, fatty oils and resinified essential oils, relative density, refractive index, optical rotation and aldehydes properties of the samples evaluated. For superior insight for chemical ingredients of the products, Thin Layer Chromatography (TLC) and Gas Chromatography-Mass Spectrometry (GC-MS) analysis were employed. Results denoted that all samples obtained from Turkish Market incompatible with the standards of EP. In view of these data, it was shown that enriched regulation mechanisms are required. When the variance between the sources of purchase evaluated, pharmacies are more accurate sources for purchasing such products nonetheless developments are yet needed. [ABSTRACT FROM AUTHOR]

The present study was conducted to document the indigenous knowledge on folk medicines of the Karbi tribe in three remote villages of West Karbi Anglong district, Assam. A total of 80 ethnomedicinal plants recorded were used in treatment of 31 different ailments. Data were collected through restructured questionnaire and quantitative analysis was done. Herbaceous plants occupied the maximum numbers and leaves were the most used plant part among the other parts. The Fic value ranged from 0.74-1, and the used value (UV) ranged from 0.02-1.2; Azadirachta indica was found to be have the highest UV. The study has revealed the pattern of people-plant interactions in the region and the importance of plant medicines playing a vital role in the health care practices and survival of the forest dwellers. There is utmost need of documenting the ethnomedicinal practices of Karbi tribe as they are passing those knowledge generations after generations only by means of practical utilizations without proper pharmacopoeia. [ABSTRACT FROM AUTHOR]

Background Irritable bowel syndrome is a very common condition in the elderly, and it can also be extremely disabling being able to go to undermine the patient’s independence. We wanted to conduct a study on the Territory to test a recently approved molecule for treating a variant with constipation-predominant irritable bowel syndrome, testing the treatment in a cohort of elderly subjects and comparing the results with those of other existing therapies. Here we exposed the results of our experience. Material and Methods We conducted an open-label study in the general medicine setting, enrolling patients who appeared eligible for drug treatment with the study drug during the medical examination. So we examined 20 elderly patients. Half of the patients were treated with linaclotide 290 mcg, the other 50% with macrogol 27.6 g (25%) and psyllium 2 sachets/day (25%), continuing the treatment up to 12 weeks. Results There was a reduction of bloating in 70% of the Linaclotide group and 80% of the macrogol and psyllium group, an improvement/reduction of tenesmus in 100% of patients in the three groups, with a change in the quality of stool occurring with Bristol Stool Scale assessment. 60% of patients failed to complete therapy in 3 months. Conclusions Linaclotide is an innovative drug increasingly gaining space in the pharmacopoeia in the possession of doctors for treating intestinal disorders on a functional basis. The limited experience has shown little tolerance of Linaclotide compared to treatments for longer in force, especially in the elderly. [ABSTRACT FROM AUTHOR]

In hepatocellular carcinoma treatment, sorafenib, oxaliplatin, 5-fluorouracil, capecitabine, lenvatinib, and donafenib are first-line drugs; regorafenib, apatinib, and cabozantinib are second-line drugs; and oxycodone, morphine, and fentanyl are commonly used analgesics. However, the high degree of interand intra-individual variability in the efficacy and toxicity of these drugs remains an urgent issue. Therapeutic drug monitoring (TDM) is the most reliable technical means for evaluating drug safety and efficacy. Therefore, we developed an ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for simultaneous TDM of three chemotherapy drugs (5-fluorouracil, oxaliplatin, and capecitabin), six targeted drugs (sorafenib, donafenib, apatinib, cabozantinib, regorafenib, and lenvatinib), and three analgesics (morphine, fentanyl, and oxycodone). We extracted 12 analytes and isotope internal standards (ISs) from plasma samples by magnetic solid phase extraction (mSPE) and separated them using a ZORBAX Eclipse Plus C18 column with water containing 0.1% formic acid and methanol containing 0.1% formic acid as the mobile phase. The analytical performance of our method in terms of sensitivity, linearity, specificity, carryover, precision, limit of quantification, matrix effect, accuracy, dilution integrity, extraction recovery, stability, and crosstalk of all the analytes under different conditions met all the criteria stipulated by the guidelines of the Chinese Pharmacopoeia and U.S. Food and Drug Administration. The response function was estimated at 10.0-10 000.0 ng/mL for sorafenib, donafenib, apatinib, cabozantinib, regorafenib, and lenvatinib, and 20.0-20 000.0 ng/mL for 5-fluorouracil, oxaliplatin, capecitabin, morphine, fentanyl, and oxycodone, with a correlation of > 0.9956 for all compounds. The precision and accuracy of all analytes were < 7.21% and 5.62%, respectively. Our study provides empirical support for a simple, reliable, specific, and suitable technique for clinical TDM and pharmacokinetics. [ABSTRACT FROM AUTHOR]