Explore the vast range of titles available.

A simple, eco-friendly, and precise isocratic RP-HPLC method was developed and validated for the simultaneous determination of bambuterol hydrochloride (BBL) and montelukast sodium (MTK). Separation was performed on an Inertsil C18 column (250 × 4.6 mm, 5 μm) using ethanol/0.025 M phosphate buffer (pH 3.0) at 70:30 (v/v) on an Agilent 1200 Infinity II system. The method complied with ICH criteria and showed linearity over 1.20–100.00 µg mL⁻¹ (BBL) and 5.00–100.00 µg mL⁻¹ (MTK). Application to a combined tablet dosage form yielded mean recoveries of 100.92 ± 1.08% (BBL) and 99.39 ± 1.41% (MTK). Dissolution profiling was performed in 900 mL of 0.5% sodium lauryl sulfate medium. Method greenness and sustainability were benchmarked against a reported procedure using multiple tools, Analytical Eco-Scale, MoGAPI, AGREE, RGB-12, D-CHEMS-1, GEAR, CaFRI, CACI, and BAGI demonstrating a safer solvent profile via ethanol/buffer. Notably, the separation time is longer (≈ 16 min), indicating a deliberate trade-off between reduced solvent hazard and throughput; analytical performance was maintained. Overall, the method offers a robust, greener alternative for routine assay and dissolution testing of BBL and MTK in pharmaceuticals.

For the treatment of rhinitis and asthma, a combination of Montelukast sodium and Bilastine has just been approved. Based on the first derivative of synchronous fluorescence, the current work developed a green, highly accurate, sensitive, and selective spectroscopic approach for estimating Montelukast sodium and Bilastine in pharmaceutical dosage form without previous separation. The selected technique focuses on measuring the synchronized fluorescence of the studied medications at a fixed wavelength range (Δλ) = 110 nm, and using the amplitude of the first derivative's peak at 381 and 324 nm, for quantitative estimation of Montelukast sodium and Bilastine, respectively. The impacts of different factors on the referred drugs' synchronized fluorescence intensity were investigated and adjusted. The calibration plots for were found to be linear over concentration ranges of 50–2000 ng mL−1 for Montelukast sodium and 50–1000 ng mL−1 for Bilastine. Montelukast sodium and Bilastine have LODs of 16.5 and 10.9 ng mL−1, respectively. In addition, LOQs were: 49.9 and 33.0 ng mL−1, for both drugs, respectively. The developed method was successfully employed to quantify the two drugs in synthetic tablets mixture and in laboratory prepared mixtures containing varied Montelukast and Bilastine ratios. To compare the results with the published analytical approach, a variance ratio F-test and a student t-test were used, which revealed no significant differences.

The development of sustainable analytical methodologies that minimize hazards, waste generation, and energy consumption has become crucial. This study introduces pioneering green‒blue-white approaches for the simultaneous quantification of montelukast sodium (MLK) and fexofenadine hydrochloride (FEX) in combination formulations. The first approach employs an ultra-performance liquid chromatographic method (UPLC) with a green micellar mobile phase of 0.02 M sodium dodecyl sulfate and 10% 1-pentanol (65:35%). The method demonstrated excellent resolution, peak symmetry, and a short analysis time, with retention times of 3.53 min for MLK and 1.67 min for FEX. The MLK and FEX linearities were 1–260 and 1.2–312 μg/mL, respectively. The second approach involves complementary built-in spectroscopic techniques (second derivative, third derivative, and ratio difference methods) using water as a solvent, providing a green, simple, low-cost alternative in laboratories where expensive chromatographic devices may not be readily available. The MLK and FEX linearities were 3–50 and 3–60 μg/mL, respectively. All methods were comprehensively validated and showed satisfactory results. The proposed methods demonstrated excellent linearity (r2 ≥ 0.9990), accuracy (recovery 98.5–101.5%), and precision (RSD ≤ 2%) across wide concentration ranges. A multifaceted evaluation was conducted to assess the environmental sustainability, real-world applicability, and economic viability of the proposed methods in comparison with previously reported techniques. This comprehensive assessment leveraged several state-of-the-art tools, including NEMI, ComplexGAPI, AGREE, ESA, BAGI, and RGB12. The suggested approaches exhibited favorable quadrant profiles in the NEMI and ComplexGAPI assessments, coupled with higher AGREE scores (0.90, 0.86) than reported (0.62, 0.74, 0.75, 0.69, 0.74, 0.74, and 0.75), in addition to higher ESA score (88, 92) than reported (75, 84, 85, 79, 82, 82, and 83), collectively affirming their environmentally friendly credentials. Moreover, we embraced the innovative notions of 'blueness' and 'whiteness' assessment by harnessing the recently formulated BAGI and RGB12 algorithms. The higher BAGI score (90, 82.5) than reported (72.5, 70, 70, 67.5, 67.5, 67.5, and 72.5), confirmed the excellent real-world applicability of the proposed methods, while the notable RGB12 indices (89.8, 88.1) than reported (67.8, 72.8, 71.5, 67.1, 73.7, 70.3, and 73.2), validated their cost-effectiveness and overall sustainability, contributing to an eco-friendly future for quality control processes.

This study aims to develop and validate a specific, precise, and robust RP-HPLC method for the impurity profiling of Montelukast sodium and Fexofenadine in their combined tablet formulation. The method ensures accurate detection and quantification of impurities and degradation products, supporting quality control and stability testing. Chromatographic separation was achieved using a YMC Pack ODS column (150 × 4.6 mm, 3 μm) coupled with an Adhoc Scientific Ghost Terminator column (50 × 4.6 mm). A gradient elution was employed, starting at 0% mobile phase B, increasing to 20% at 15 min, 47% at 45 min, 70% at 50 min, 75% at 62 min, and 80% at 70 min, followed by re-equilibration to initial conditions by 80 min. Mobile phase A consisted of 0.01 M ammonium acetate buffer (pH 6.0): acetonitrile (80:20), and mobile phase B was acetonitrile: methanol (80:20). The flow rate was 1.0 mL/min, with a column temperature of 40 °C, sample temperature of 5 °C, and an injection volume of 15 µL. Detection was carried out at 240 nm using a UV/PDA detector. The method was validated for linearity, precision, accuracy, and stability-indicating capability. It showed excellent linearity (r² >0.999) from the LOQ to 150% of impurity limits. Recovery ranged from 80.0 to 120.0%, with %RSD below 5.0%, confirming high precision and accuracy. The method effectively identified known impurities, such as Fexofenadine-related compound A, Fexofenadine-related compound C, Montelukast sulfoxide, Montelukast cis, Montelukast ketone and Montelukast styrene and degradation products, proving its suitability for routine quality control and stability assessment in pharmaceutical manufacturing.

Montelukast sodium (MLK) and Levocetirizine dihydrochloride (LCZ) are widely prescribed medications with promising therapeutic potential against COVID-19. However, existing analytical methods for their quantification are unsustainable, relying on toxic solvents and expensive instrumentation. Herein, we pioneer a green, cost-effective chemometrics approach for MLK and LCZ analysis using UV spectroscopy and intelligent multivariate calibration. Following a multilevel multifactor experimental design, UV spectral data was acquired for 25 synthetic mixtures and modeled via classical least squares (CLS), principal component regression (PCR), partial least squares (PLS), and genetic algorithm-PLS (GA-PLS) techniques. Latin hypercube sampling (LHS) strategically constructed an optimal validation set of 13 mixtures for unbiased predictive performance assessment. Following optimization of the models regarding latent variables (LVs) and wavelength region, the optimum root mean square error of cross-validation (RMSECV) was attained at 2 LVs for the 210–400 nm spectral range (191 data points). The GA-PLS model demonstrated superb accuracy, with recovery percentages (R%) from 98 to 102% for both analytes, and root mean square error of calibration (RMSEC) and prediction (RMSEP) of (0.0943, 0.1872) and (0.1926, 0.1779) for MLK and LCZ, respectively, as well bias-corrected mean square error of prediction (BCMSEP) of -0.0029 and 0.0176, relative root mean square error of prediction (RRMSEP) reaching 0.7516 and 0.6585, and limits of detection (LOD) reaching 0.0813 and 0.2273 for MLK and LCZ respectively. Practical pharmaceutical sample analysis was successfully confirmed via standard additions. We further conducted pioneering multidimensional sustainability evaluations using state-of-the-art greenness, blueness, and whiteness tools. The method demonstrated favorable environmental metrics across all assessment tools. The obtained Green National Environmental Method Index (NEMI), and Complementary Green Analytical Procedure Index (ComplexGAPI) quadrants affirmed green analytical principles. Additionally, the method had a high Analytical Greenness Metric (AGREE) score (0.90) and a low carbon footprint (0.021), indicating environmental friendliness. We also applied blueness and whiteness assessments using the high Blue Applicability Grade Index (BAGI) and Red–Green–Blue 12 (RGB 12) algorithms. The high BAGI (90) and RGB 12 (90.8) scores confirmed the method's strong applicability, cost-effectiveness, and sustainability. This work puts forward an optimal, economically viable green chemistry paradigm for pharmaceutical quality control aligned with sustainable development goals.

The research objective was to evaluate the effectiveness and safety of using montelukast sodium alongside budesonide/formoterol in individuals with obstructive airway diseases. A prospective study was conducted on 100 obstructive airway disease patients who had received treatment of budesonide/formoterol inhalation powder (control group, = 50) or montelukast sodium tablets supplemented to budesonide/formoterol inhalation powder (observation group, = 50). Both groups underwent a 3-month treatment, and the assessment of effectiveness relied on symptom improvement, with a comparative analysis of outcomes for symptoms such as cough, sputum, wheezing, and dyspnoea. The evaluation involved measuring pulmonary function indicators like FEV1 and FEV1/FVC as well as comparing serum markers such as interleukin-6, tumor necrosis factor-α, eosinophils count, and fractional exhaled nitric oxide. With a total effective rate of 94.00%, the observation group showed a significant improvement in comparison to the control group, which achieved 80% effectiveness ( < 0.05). Additionally, the observation group experienced a significantly faster alleviation of symptoms such as cough, sputum, wheezing, and dyspnoea than the control group ( < 0.05). Post-treatment, the observation group showed significantly better pulmonary function and lower inflammatory markers in comparison to the control group ( < 0.05). Notably, there was no significant variance in the occurrence of adverse reactions between groups. Montelukast sodium in conjunction with budesonide/formoterol presents a pronounced advantage in effectiveness and safety for treating obstructive airway diseases in individuals. It effectively alleviates symptoms, enhances pulmonary function, and diminishes inflammation, offering critical insights for clinical management.

Background Repurposing off-label drugs during epidemics or pandemics with unknown/known pathogens, particularly when their side effects and complications are already known, can be a strategic approach, as seen during the COVID-19 pandemic. Developing surrogate in vitro experimental models (passage-to-passage), which mimic epidemic/pandemic-like transmission (human-to-human), may enhance this repurposing process. This study evaluates montelukast sodium (MLS), a US FDA-approved leukotriene receptor antagonist for asthma, to explore its potential repurposing antiviral effects against bovine respiratory syncytial virus (BRSV), which has basic similarities to human respiratory syncytial virus (HRSV) as both belong to the Pneumoviridae family. Methods An in vitro serial passage model was developed using MDBK cells infected with a local wild-type strain of BRSV (43TR2018). The cytotoxicity of MLS was assessed via the trypan blue exclusion method, identifying non-toxic concentrations. The impact of MLS on viral spread and infectivity was measured through TCID50 values over 10 passages. Viral loads were confirmed by nested RT-PCR and quantified using qPCR, while apoptosis, necrosis, and nitric oxide production were evaluated through staining and nitrite assays. Data were analyzed using ANOVA and Tukey's test ( p  < 0.05). Results Control cells exhibited 97.16% viability, with 10 µM and 20 µM MLS concentrations maintaining viabilities of 89.2% and 87.3%, respectively. Viral titers significantly decreased at higher concentrations of MLS (up to 99.94% inhibition). Apoptosis rates decreased in MLS-treated cells, and live cell percentages improved, especially at 20 µM. Nitric oxide levels showed no significant differences across groups. Conclusion MLS demonstrated a dose-dependent antiviral effect against BRSV, achieving 99% viral inhibition properties in MDBK cells. These promising results warrant further investigation into the antiviral mechanisms of MLS.

Montelukastsodium is a selective, orally acting leukotriene receptor antagonist that is used for the treatment of asthma and seasonal allergic rhinitis. In addition, patients with asthma need fast and immediate action of drug and avoidance of water is also desirable. Further, chewable tablets are beneficial for patients having difficulty in swallowing. The objective of the present study was to develop chewable tablets containing different compositions of ingredients by using direct compression method. Microcrystalline cellulose, mannitol, magnesium stearate, cross povidone and aspartame were used in the formulation in different concentrations. The prepared tablets were evaluated for various parameters like weight variation, thickness, friability, drug content, and in-vitro drug release. The in-vitro release study of formulation F7 was found to show 98% drug release in 30 minutes and stability studies showed no significant changes.

Objectives: To investigate the effects of Montelukast sodium combined with Budesonide aerosol on airway function and T lymphocytes in asthmatic children. Methods: The records of 86 pediatric asthma patients, treated in Huzhou Maternal and Child Health Hospital from February 2020 to March 2021, were studied retrospectively. Of them, 40 children received routine treatment + budesonide atomizer (Group-I), and 46 patients received routine treatment + budesonide atomizer + montelukast sodium (Group-II). The improvement in airway and lung function, and T-lymphocyte count in both groups after 3 months of corresponding treatment were analyzed. Results: After three months of treatment, expiratory flow rate (TEF) with the tidal volume of 25%, 50% and 75%, was significantly higher in Group-II than Group-I (P<0.05). CD8+ expression in Group-II was lower, and CD3+, CD4+ and CD4+/CD8+ were higher than those in Group-I (P<0.05). There was a significant difference in the levels of inflammatory factors between the two groups. The levels of IL-4, IL-5 and IFN-γ in Group-II were lower than those in Group-I (P<0.05). Conclusions: In the clinical treatment of asthmatic children, in combination with routine treatment, budesonide atomizer and montelukast sodium can effectively promote the improvement of airway function, regulate T lymphocytes levels, reduce inflammatory reaction and improve the total clinical curative effect. doi: https://doi.org/10.12669/pjms.38.5.5749 How to cite this:Jin W, Zhao Z, Zhou D. Effect of Montelukast sodium combined with Budesonide aerosol on airway function and T lymphocytes in asthmatic children. Pak J Med Sci. 2022;38(5):---. doi: https://doi.org/10.12669/pjms.38.5.5749 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

This research aims to produce orodispersible films (ODFs) and determine their potential use in the oral delivery of montelukast sodium for asthma treatment and allergic rhinitis. ODFs were successfully developed by Three-dimensional (3D) printing using propylene glycol (PG), and hydroxypropyl methylcellulose (HPMC), polyethylene glycol 400 (PEG). Finally, the amount of montelukast sodium in the ODFs was 5% (w/w). Drug-excipients compatibility with Fourier Transformed Infrared (FTIR) spectroscopy, mass uniformity, thickness, disintegration time, folding endurance, moisture absorption, pH, in vitro drug release (dissolution), drug content, moisture loss, moisture content, mechanical properties, and cytotoxicity studies were performed on the prepared films. All formulations disintegrated in approximately 40 s. Over 98% of drug release from all films within 2 min was confirmed. It was reported that Fm1-4 (8% HPMC and 1% PEG) and Fm2-4 (10% HPMC and 3% PEG) are more suitable for drug content, but Fm2-4 may be the ideal formulation considering its durability and transportability properties. Based on the characterization results and in vitro release values, the montelukast sodium ODF can be an option for other dosage forms. It was concluded that the formulations did not show toxic potential by in vitro cytotoxicity study with 3T3 cells. This new formulation can efficiently treat allergic rhinitis and asthma diseases. Graphical Abstract