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Objective To explore the clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma. Methods A total of 102 patients with bronchial asthma admitted to the hospital were enrolled between May 2022 and December 2023. According to simple randomization method, they were divided into control 1 group (montelukast sodium, n=34), control 2 group (Pingchuan prescription, n=34) and observation group (Pingchuan prescription combined with montelukast sodium, n=51). All patients were treated for 21 d. The clinical curative effect in the three groups was evaluated. The scores of TCM syndromes, inflammatory factors [interleukin (IL)-4, IL-17, interferon (IFN)-γ, transforming growth factor-β1 (TGF-β1), immunoglobulin (Ig)E] and scores of the test for respiratory and asthma control in kids (TRACK) in the three groups were compared before and after treatment. The adverse reactions were recorded. Results Compared with control 1 group and control 2 group, total response rate was higher in observation group (P<0.05). After treatment, scores of TCM syndromes (wheezing due to phlegm in throat, tachypnea, choking)in observation group were lower than those in control 1 group and control 2 group (P<0.05). After treatment, levels of IL-4, IL-17, TGF-β1 and IgE in observation group were lower than those in control 1 group and control 2 group, while IFN-γ level and TRACK score were higher than those in control 1 group and control 2 group (P<0.05). There was no difference in adverse reactions among the three groups (P>0.05). Conclusion Pingchuan prescription combined with montelukast sodium could improve clinical curative effect in patients with bronchial asthma, which was beneficial to alleviate inflammatory response and disease severity, with certain safety. [ABSTRACT FROM AUTHOR]

This study addresses the significant environmental challenge of pharmaceutical pollutants by demonstrating the effectiveness of a hybrid electrocoagulation–adsorption (EC-A) technique for removing Montelukast Sodium (MS) from contaminated water. The research was conducted in three stages—adsorption, electrocoagulation, and adsorption using the residual water from the electrocoagulation process. The adsorbent materials were characterised using various analytical techniques: X-ray Diffraction (XRD) for determining the crystalline structure, Energy-Dispersive X-ray Spectroscopy (EDX) for elemental composition, Scanning Electron Microscopy (SEM) for surface morphology, and Fourier Transform Infrared Spectroscopy (FTIR) for identifying functional groups before and after interaction with the pollutants. The adsorption phase achieved optimal results at a pH of 3 and a contact time of 120 min, with a maximum removal efficiency of 99.5% for a starting MS concentration of 50 mg/L using Calcium Ferric Oxide–Silica Sand (CFO-SS) adsorbent. The electrocoagulation phase showed a 97% removal efficiency with a pH of 11, a current density of 20 mA, and a 5 mm electrode distance, achieved in just 20 min. Finally, the combined EC-A process, with the pH of residual water adjusted to 3, further enhanced the removal efficiency to 74%, highlighting the method's potential for pharmaceutical contaminant removal. These findings underscore the potential of the EC-A technique as a highly effective and adaptable solution for mitigating pharmaceutical contaminants in water. [ABSTRACT FROM AUTHOR]

This study addresses the significant environmental challenge of pharmaceutical pollutants by demonstrating the effectiveness of a hybrid electrocoagulation–adsorption (EC-A) technique for removing Montelukast Sodium (MS) from contaminated water. The research was conducted in three stages—adsorption, electrocoagulation, and adsorption using the residual water from the electrocoagulation process. The adsorbent materials were characterised using various analytical techniques: X-ray Diffraction (XRD) for determining the crystalline structure, Energy-Dispersive X-ray Spectroscopy (EDX) for elemental composition, Scanning Electron Microscopy (SEM) for surface morphology, and Fourier Transform Infrared Spectroscopy (FTIR) for identifying functional groups before and after interaction with the pollutants. The adsorption phase achieved optimal results at a pH of 3 and a contact time of 120 min, with a maximum removal efficiency of 99.5% for a starting MS concentration of 50 mg/L using Calcium Ferric Oxide–Silica Sand (CFO-SS) adsorbent. The electrocoagulation phase showed a 97% removal efficiency with a pH of 11, a current density of 20 mA, and a 5 mm electrode distance, achieved in just 20 min. Finally, the combined EC-A process, with the pH of residual water adjusted to 3, further enhanced the removal efficiency to 74%, highlighting the method’s potential for pharmaceutical contaminant removal. These findings underscore the potential of the EC-A technique as a highly effective and adaptable solution for mitigating pharmaceutical contaminants in water.

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

Abstract Background Since inflammatory mediators play a crucial role in the pathophysiology of neonatal sepsis. Montelukast, as an anti-inflammatory drug, could be a beneficial therapy. In searching the literature, no previous research addressed the role of Montelukast in neonatal sepsis; hence, this study aimed to explore the adjuvant role of Montelukast in regulating the inflammatory response associated with neonatal sepsis and its associated effect on the clinical outcomes. Methods An open-label, randomized controlled intervention trial conducted on 40 late preterm newborn infants (gestational age 340/7 to 366/7 weeks) admitted to NICU, with clinical evidence of sepsis. In the Montelukast group (n = 20), infants received oral Montelukast once daily for 10 days (infant's weight 2 kg received 2 mg) with antibiotics plus routine supportive care. In the routine care group (n = 20), infants received antibiotics plus routine supportive care. Primary outcome was the serum level of tumor necrosis factor (TNF) alpha at day 10 of therapy. Secondary clinical and laboratory outcomes were reported along hospital admission. Results Baseline characteristics were non-significantly different between both groups. After 10 days of therapy, TNF alpha level was significantly lower in the Montelukast group (80.73 ± 50.25 versus 119.54 ± 58.46; p = 0.03). There were non-significant differences between both groups regarding duration of NICU admission, antibiotics duration or modalities and duration of respiratory support. C-reactive protein didn’t differ between both groups (p = 0.256). No documented significant adverse effects of Montelukast during the study period. Conclusions In late preterm neonates with sepsis, 10 days of Montelukast therapy as an adjuvant to antibiotics lowered TNF alpha level without any impact on clinical outcomes. Trial registration The study was approved by Mansoura Faculty of Medicine institutional research board (IRB) (MS/17.06.95) and it was registered in clinical trials database (clinicaltrials.gov, ID: NCT04474327 ; registered July 16, 2020).

A simple, accurate and economical UV spectroscopic method has been developed for the simultaneous estimation of olopatadine hydrochloride and montelukast sodium. The developed method is based on the determination of the two drugs using UV absorbance correction principle. The wavelengths chosen for analysis were 352 nm for montelukast sodium (as absorbance due to the other drug was nil at this wavelength) and 298.5 nm for olopatadine hydrochloride (corrected for absorbance due to montelukast sodium) with water as diluent. The Beer-Lambert's range for the two drugs was found to be 2-100 μg mL-1 at 298.5 nm and 2-70 μg mL-1 at 352 nm for montelukast sodium with r2 of ≥ 0.990. The developed method was validated as per ICH guidelines and the percentage assay results were within acceptable limits. The developed method can thus be successfully used for the regular analysis of olopatadine hydrochloride and montelukast sodium in bulk and in combination. [ABSTRACT FROM AUTHOR]

An innovative, simple, accurate, sensitive, and eco‐friendly synchronous fluorescence spectrofluorimetric method has been developed for the simultaneous analysis of montelukast sodium (MON) and fexofenadine hydrochloride (FEX). The method relies on measuring the relative synchronous fluorescence intensity of both drugs using Δλ of 60 nm in methanol at 405 nm for MON and 288 nm for FEX. The experimental parameters influencing the developed method were investigated and optimized. The method was linear over the ranges 0.1–2.0 and 2.0–20.0 μg/ml for MON and FEX, respectively. The limits of detection were 0.018 and 0.441 μg/ml, and the limits of quantitation were 0.055 and 1.336 μg/ml for MON and FEX, respectively. The developed method was applied successfully for the determination of the two drugs in their newly released fixed‐dose combination prescribed for the treatment of allergic rhinitis. The mean per cent recoveries were found to be 100.680 ± 0.890 and 100.110 ± 0.940 for MON and FEX, respectively. Furthermore, the method was found to be eco‐friendly green as was evaluated according to the Green Analytical Procedure Index tool guidelines and analytical eco‐scale. [ABSTRACT FROM AUTHOR]

Background: Since inflammatory mediators play a crucial role in the pathophysiology of neonatal sepsis. Montelukast, as an anti-inflammatory drug, could be a beneficial therapy. In searching the literature, no previous research addressed the role of Montelukast in neonatal sepsis; hence, this study aimed to explore the adjuvant role of Montelukast in regulating the inflammatory response associated with neonatal sepsis and its associated effect on the clinical outcomes. Methods: An open-label, randomized controlled intervention trial conducted on 40 late preterm newborn infants (gestational age 340/7 to 366/7 weeks) admitted to NICU, with clinical evidence of sepsis. In the Montelukast group (n = 20), infants received oral Montelukast once daily for 10 days (infant's weight < 2 kg received 1.5 mg whereas > 2 kg received 2 mg) with antibiotics plus routine supportive care. In the routine care group (n = 20), infants received antibiotics plus routine supportive care. Primary outcome was the serum level of tumor necrosis factor (TNF) alpha at day 10 of therapy. Secondary clinical and laboratory outcomes were reported along hospital admission. Results: Baseline characteristics were non-significantly different between both groups. After 10 days of therapy, TNF alpha level was significantly lower in the Montelukast group (80.73 ± 50.25 versus 119.54 ± 58.46; p = 0.03). There were non-significant differences between both groups regarding duration of NICU admission, antibiotics duration or modalities and duration of respiratory support. C-reactive protein didn't differ between both groups (p = 0.256). No documented significant adverse effects of Montelukast during the study period. Conclusions: In late preterm neonates with sepsis, 10 days of Montelukast therapy as an adjuvant to antibiotics lowered TNF alpha level without any impact on clinical outcomes. Trial registration: The study was approved by Mansoura Faculty of Medicine institutional research board (IRB) (MS/17.06.95) and it was registered in clinical trials database (clinicaltrials.gov, ID: NCT04474327; registered July 16, 2020). [ABSTRACT FROM AUTHOR]

Allergic rhinitis (AR) is very common in adolescents, and current treatment options are complex and unsatisfactory. The objective of this study was to analyze the association of lysyl oxidase (LOX) gene G473A polymorphism with susceptibility to AR in children. In addition, we analyzed the therapeutic effect of montelukast sodium on AR. Forty-five children with AR (research group, 8.16±2.88 years old) and 51 healthy children (control group, 8.22±3.87 years old) during the same period were selected. The LOX gene G473A polymorphism was detected with polymerase chain reaction (PCR)-restriction fragment length polymorphism method. The effect of G473A polymorphism in the occurrence of AR was assessed by logistic regression analysis. In addition, the levels of C-reactive protein (CRP), Interleukin (IL-6), and IL-8 were measured to observe the relationship between G473A polymorphism and inflammatory factors. Finally, montelukast sodium was given to children with AR to investigate the effect of G473A polymorphism on clinical outcomes. The number of G473A polymorphisms in the research group was not significantly different from the control group for GA-type (P = 0.521). However, the number of GG-type polymorphisms was less while the number of type AA was more than the control group (P = 0.044 and 0.046). Children carrying the AA gene had an approximately 4-fold increased risk of AR, while those carrying the GG gene had a decreased risk (P < 0.001). Moreover, children carrying the GG gene had lower levels of CRP, IL-6, and IL-8 and better clinical outcomes, while those carrying the AA gene had higher levels of inflammatory factors and worse outcomes (P<0.05). LOX gene G473A polymorphism is closely associated with AR pathogenesis and may have an important research value in antagonizing the therapeutic effect of montelukast sodium. [ABSTRACT FROM AUTHOR]

Montelukast sodium (MS) as an anti‐inflammatory agent in asthma requires a drug delivery system to sustain release at specific doses. ZIF‐8 commonly used in drug delivery systems due to its low cytotoxicity and biodegradability was functionalized with 3‐aminopropyltrimethoxysilane (APTES) as a carrier (ZIF‐8@APTES) for MS. The particles were characterized with Field emission scanning electron microscopy (FE‐SEM), Fourier transform infrared (FTIR), X‐ray diffraction (XRD), Brunauer‐Emmett‐Teller (BET) method, and thermogravimetric analysis (TGA). Furthermore, the biocompatibility of ZIF‐8@APTES‐MS on a normal murine cell line (L929) and its antioxidant activity were investigated. The results showed that MS was gradually released from ZIF‐8@APTES‐MS in phosphate buffer solution (pH 7.4) over 6 hours. ZIF‐8@APTES and ZIF‐8@APTES‐MS also had good biocompatibility properties, and significantly (P≤0.05) enhanced total antioxidant activity at high doses (32 μg/mL). In conclusion ZIF‐8@APTES‐MS can be a promising drug delivery system for MS. [ABSTRACT FROM AUTHOR]

This study aimed to determine the effects of Xiebai Zengye decoction (XBZY) on airway inflammation and respiratory function in rats with postinfectious cough (PIC), and its regulatory effects on the extracellular signal‐regulated kinase (ERK) signaling pathway. Compared with the normal group, the rats from the PIC group had significantly shortened expiratory time (TE) and enhanced pause (EEP), increased resistance (RT), and enhanced pause (Penh), along with increased levels of serum interleukin‐4 (IL‐4) and IL‐6, and decreased levels of IL‐10. The lung and colon tissues of rats from the PIC group showed histopathological changes, including inflammatory cell infiltration, damaged mucosal epithelium, and crypt structure, with significantly increased ERK mRNA and protein expression levels. Treatment with XBZY and montelukast sodium (MAS) improved the respiratory function and serum cytokine levels, reduced tissue inflammation, and decreased ERK mRNA and protein expression levels in the lung and colon tissues. In the lung tissues, XBZY treatment significantly decreased the expression of phosphorylated‐ERK (p‐ERK) protein, as well as p‐MEK1/2, p‐ERK1/2, and p‐c‐Fos proteins, while in the colon tissues, XBZY significantly decreased the expression of p‐ERK1/2 and p‐c‐Fos proteins. However, MAS treatment only showed significant improvement in the lung tissue inflammation score, and the expression level of p‐ERK protein in the lung tissue was decreased. In conclusion, the present study suggests that XBZY has a potential therapeutic effect on PIC by improving respiratory function and attenuating inflammation, and this effect may be associated with the inhibition of the ERK signaling pathway. These findings could provide a new direction for the development of treatments for PIC. However, further research is needed to elucidate the underlying molecular mechanisms of XBZY and to confirm its safety and efficacy in clinical trials. Significance statement: Postinfectious cough (PIC) accounts for 21.73% of the causes of chronic cough in Chinese children and has a higher incidence rate in preschool children. This study aims to observe the effects of Xiebai Zengye decoction (XBZY) on airway inflammation and reactivity in young rat model of PIC cough, and to explore its regulatory effects on the ERK signaling pathway, to preliminarily elucidate the mechanism of XBZY in treating PIC. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To probe into the clinical efficacy of modified Shenqi Bufei decoction combined with montelukast sodium in the treatment of chronic cough after non-small cell lung cancer surgery. METHODS: Totally 104 patients with chronic cough after non-small cell lung cancer suegery admitted into the hospital from Jun. 2020 to Jun. 2022 were extracted to be divided into the control group and the observation group via the random number table method, with 52 cases in each group. The control group was treated with Montelukaster sodium tablets, while the observation group received Shenqi Bufei decoction based on the control group. The cough symptom score, Lessister cough quality of life score, serum humoral immune indicators [immunoglobulin A (IgA), immunoglobulin M (IgM), immunoglobulin G (IgG)], serum inflammatory cytokines [C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α)] before and after treatment and safety were observed in two groups. RESULTS: After treatment, daytime cough symptom score, nighttime cough symptom score, CRP, IL-6 and TNF-α levels in both groups were lower than those before treatment, and the observation group was lower than the control group, with statistically significant differences (P<0. 05). After treatment, Lycester cough life quality score, IgA, IgM and IgG levels in both groups were higher than those before treatment, and the observe group was higher than the control group, with statistically significant difference (P < 0. 05). CONCLUSIONS: Shenqi Bufei decoction combined with montelukast sodium can reduce the occurrence of chronic cough after non-small cell lung cancer surgery, reduce cough symptom score and serum inflammatory factor expression, and improve the immune function and quality of life of patients. [ABSTRACT FROM AUTHOR]

Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board 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.)

Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board 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.)

Objectives: In-vitro comparative analysis of the release profile of levocetirizine dihydrochloride and montelukast sodium in Xyzal M Suspension and three commercially available syrup formulations. Method: The active components and their impurities were initially assayed in all formulations using a validated HPLC method. The enantiomeric impurities of montelukast sodium in different pH media were determined using the HPLC method specified in the United State Pharmacopoeia (USP) monograph. Additionally, dissolution studies and the soluble fractions of the components were evaluated in pH media that mimic the conditions of the gastrointestinal tract. The particle size was also analyzed using microscopic analysis. All parameters were examined in fresh, stressed, and aged samples of each formulation. Results: The assay results indicate the claimed potency of formulations. The total and enantiomeric impurities meet the limits set by the Indian Pharmacopoeia (<2%) and USP monograph (<0.2%), respectively. The particle size analysis demonstrated that montelukast remained suspended throughout the Xyzal M suspension. Levocetirizine in all formulations exhibited a soluble fraction of >70% after 1 and 24 hours in various pH media. For montelukast, the soluble fraction exceeded 50% in all syrup formulations. However, in Xyzal M suspension, montelukast was found to be 100% insoluble in all pH media after 1 and 24 hours, except in simulated intestinal fluid (~40-45%) after 24 hours. The absence of S-enantiomer, even in simulated intestinal fluid, indicates its presence in the pharmacologically active form. Conclusion: Xyzal M suspension is a promising dosage formulation for achieving desired pharmacological action, outperforming the syrup formulations. [ABSTRACT FROM AUTHOR]

Aim:The aim of this study was to investigate the protective effects of diclofenac sodium (DF) and montelukast sodium (ML) on acute inflammation in traumatic spinal cord injury (T-SCI).Materials and Methods:Forty Sprague-Dawley rats were randomly divided into five groups. While no intervention was made in the control group, spinal cord injury was applied to the trauma group. DF, ML and DF+ML were administered intraperitoneally to the remaining three groups after trauma. After rats were sacrificed, tissue samples containing both spinal cord and dura were subjected to histopathological examination and scored for edema, necrosis, inflammatory cells, apoptosis, neuron damage, and bleeding.Results:There was a significant difference in the histopathological changes between the control and trauma groups (p0.05). In the comparison of the control group and the other groups, no significant difference in edema was found in the tDF group (p=0.059). When the inflammatory cells were examined, it was seen that the cell amount was the least in the tDF group (p=0.068). It was observed that necrosis (p=0.1), apoptosis (p=0.061) and neural damage status (p=0.139) were the least in the tDF+ML combined group. There was no significant difference between the groups in terms of the amount of bleeding (p>0.05).Conclusion:While the use of DF alone reduced the number of edema and inflammatory cells, the combined use of DF+ML reduced the development of necrosis, apoptosis and neural damage in T-SCI.

Objective: To investigate the efficacy of Xiyanping injection combined with montelukast sodium in the treatment of children with acute bronchitis and its influence on inflammatory cytokines and cellular immune function. Methods: 180 cases of children with acute bronchitis who were admitted to the Department of Pediatrics of Hefei Second People’s Hospital from January 2021 to April2022 were selected, and they were divided into control group and observation group with 90 cases in each group according to random number table method. On the basis of conventional treatment, the control group was treated with montelukast sodium granules, and the observation group was treated with Xiyanping injection combined with montelukast sodium granules. The efficacy, symptom relief situation, inflammatory cytokines, cellular immune function indexes and the occurrence of adverse reactions were compared in the two groups. Results: Compared with the total clinical effective rate of 87.78% in the control group, 96.67% in the observation group was higher (P＜0.05). The antipyretic time, cough disappearance time and lung rale disappearance time of children in the observation group were shorter than those in the control group (P＜0.05). After treatment, the levels of serum high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and procalcitonin (PCT) in the two groups decreased, and the observation group was lower than the control group (P＜0.05). After treatment, CD8+in the two groups decreased, and the observation group was lower than the control group. CD3+, CD4+, CD4+/CD8+increased, and the observation group was higher than the control group (P＜0.05). There were no serious adverse reactions in the two groups. Conclusion: Xiyanping injection combined with montelukast sodium in the treatment of children with acute bronchitis can improve the clinical therapeutic effect, which may be related to regulating the level of inflammatory cytokines and improving the cellular immune function of the body. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To probe into the efficacy of Xiao’er Xiaoji Zhike granules combined with montelukast sodium in the treatment of cough variant asthma (CVA) in children. METHODS: Totally 96 children with CVA admitted into the hospital from Mar. 2020 to Dec. 2021 were extracted to be divided into the control group and the research group via the two-color ball method, with 48 cases in each group. The control group was treated with montelukast sodium, while the research group received Xiao’ er Xiaoji Zhike granules. The efficacy, levels of inflammatory factors [interleukin-6 (IL-6), C-reactive protein (CRP) and tumor necrosis factor-α (TNF-α)], pulmonary function [peak expiratory flow (PEF), forced expiratory volume at one second (FEV1 ) and forced vital capacity (FVC)] and related scale scores before and after treatment, the incidence of adverse drug reactions during treatment in two groups were observed. RESULTS: The total clinical effective rate of the research group was 93. 75% (45/48), higher than 75. 00% (36/48) of the control group, the difference was statistically significant (P<0. 05). After 7 d of treatment, the levels of IL-6, CRP and TNF-α in two groups decreased compared with before treatment, and the research group was lower than the control group, with statistically significant differences (P <0. 05). The PEF, FEV1 and FVC of two groups after treatment were higher than those before treatment, and the research group was higher than the control group, the differences were statistically significant (P <0. 05). After 7 d of treatment, the Leicester Cough Quality of life questionnaire score, Asthma Control Test score and Bronchial Asthma Medication Adherence Scale score in two groups after treatment were higher than those before treatment, and the research group was higher than the control group, the differences were statistically significant (P <0. 05). There were no severe adverse drug reactions in both groups. CONCLUSIONS: Xiao’ er Xiaoji Zhike granules combined with montelukast sodium can effectively alleviate the cough symptoms, improve lung function and reduce the level of inflammatory factors in children with CVA. [ABSTRACT FROM AUTHOR]

There is a rising interest in the development of orodispersible films (ODFs) as an alternative to fast dissolving tablets which is attributed to their faster dissolution rate, higher durability, and better patient compliance. Owing to its rheological and also various functional properties, many researchers tried to discover some of the pharmaceutical applications of L. sativum in the development of various dosage forms, in addition to its therapeutic studies, such as binding, dissolving, gelling and sustained release dosage form. The fast-dissolving oral film of the Montelukast sodium by using Cress seed mucilage (CSM) and HPMC (15cps) is prepared by solvent casting method. The fast-dissolving oral film evaluated for folding endurance, surface pH, in-vitro disintegration time, drug content and in-vitro drug release. The physical appearance and folding endurance properties were found to be reasonably good and electron microscopy shows that films are clear, colorless with smooth surface. The drug content of all the films was in the range suggesting that drug was uniformly dispersed throughout all films. The present study was an attempt to develop and evaluate an oral fast dissolving drug delivery system using cress seed mucilage as a film former. [ABSTRACT FROM AUTHOR]

The synergistic effect of Fexofenadine Hydrochloride an anti-histamine agent and Montelukast Sodium in treating allergies by antagonizing histamine and leukotriene prompted their use as effctive fixed dosage form combination. The current research scenario is about concurrent analysis of these drugs by spectroflourimetric method with the wavelength of excitation and emission 261nm and 287nm for Fexofenadine Hydrochloride and 392nm 487nm for Montelukast Sodium. The Calibration curves were observed to be rectilinear over the concentration ranges 20-100 µg/mL for Fexofenadine Hydrochloride and 2-10 µg/mL for Montelukast Sodium with good correlation coefficient in the range of 0.997 and 0.999 respectively in phosphate buffer, pH 6.8. The LOD and LOQ were found to be 0.36 µg/mL and 2.53 µg/mL for Fexofenadine Hydrochloride and 0.73 µg/mL and 2.152 µg/mL for Montelukast Sodium respectively. The assay was found to be in range of 105% for fexofenadine hydrochloride and 110% for montelukast sodium solution and %RSD values for precision and accuracy studies were found to be less than 2. The results obtained for both drugs (fexofenadine and montelukast) for various parameters were validated according to ICH guidelines. The present method can be applied for quantification of both drugs concurrently in pharmaceutical dosage forms. [ABSTRACT FROM AUTHOR]

Copyright of Namık Kemal Tıp Dergisi is the property of Galenos Yayinevi Tic. LTD. STI 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.)

To manage early morning symptoms of nocturnal bronchial asthma, a chronotherapeutic drug delivery system (ChrDDS) of montelukast sodium was designed and developed utilizing non-saccharide, fully synthetic Parteck® SRP 80, and hydrophilic cellulose derivative hydroxypropyl methylcellulose (HPMC). Recurrent lag phase, each followed by the release of a fraction of the drug dose, can be achieved by formulating a "tablets in a capsule" system containing more than one compressed coated tablet encapsulated in an enteric-coated capsule. Lag time in this study was controlled by the compressed coating of HPMC K4M and a blend of ethyl cellulose and Carbopol polymer. Assembly of the system includes two compressed coated tablets encapsulated in a capsule which was further proceeded for enteric coating in a conventional, a novel wax-based, and a Eudracap™ enteric-coated capsule. The optimized formulation of directly compressed tablets of Parteck ® SRP 80 showed a hardness of 8.8 kg/cm2 which is 1.25-fold higher than wet granulated tablets of HPMC. In vitro release data of matrix tablets of Parteck® SRP 80 demonstrated controlled release of drug for a duration of up to 10.8–11 h with changing ratio of polymer and filler. Eudracap™ capsule showed a minimum acid uptake value of 1.75%. The current approach can open a path for the time-regulated release of montelukast that may be beneficial for individuals with episodes of asthma attacks mostly in the early morning. [ABSTRACT FROM AUTHOR]

An extended release dosage form based on encapsulating the challenging drug busulfan within microspheres of the biodegradable, biocompatible and biosynthesized poly(3-hydroxybutyrate- co -3-hydroxyvalerate) (PHBV) polyester was achieved. The used (PHBV) polymer was biosynthesized by the halophilic archaeon Haloferax mediterranei from date waste biomass as feed-stock. PHBV microspheres of 1.2–2.1 μm diameter were successfully fabricated and loaded with busulfan with an encapsulation efficiency of 29.2 ± 0.2%. In addition, PHBV microspheres of 1.5–3.5 μm diameter and loaded with montelukast sodium (MK) drug were also fabricated with an encapsulation efficiency of 16.0 ± 0.4%. The double-emulsion solvent evaporation method was used to fabricate the drug-loaded microspheres. The drug-loaded microspheres have been characterized by XRD, FTIR and SEM, and confirmed to be successfully fabricated. The drugs in vitro release profiles have shown extended release for up to 3 days in case of busulfan and 8 h in case of montelukast sodium. The in vitro release profiles for busulfan and montelukast suggest that these drug-loaded microcapsules can be efficiently used as new dosage forms to solve the current issues of busulfan administration protocols, and to introduce a new dosage form for montelukast with extended release performance. • Biocompatible, biodegradable and green drug-encapsulating materials of poly(3-hydroxybutyrate- co -3-hydroxyvalerate) (PHBV) biosynthesized from date waste. • Anticancer drug busulfan loaded into PHBV polymer microspheres as promising intravenous dosage form. • Extended release microcapsules for the drugs busulfan and montelukast with up to 3 days continuous release. [Display omitted] [ABSTRACT FROM AUTHOR]

Weihong Li,1,* Yanrong Wang,1,* Yingzi Pei,2 Yue Xia2 1GCP Office of Cangzhou Central Hospital, Cangzhou, Hebei, 061000, People’s Republic of China; 2Research Center of Beijing Fuyuan Pharmaceutical Co., Ltd. (Formerly Beijing Wansheng Pharmaceutical Co., Ltd.), Beijing, 101113, People’s Republic of China*These authors contributed equally to this workCorrespondence: Weihong LiGCP Office of Cangzhou Central Hospital, No. 16 on Xinhua Road, Cangzhou, Hebei, 061000, People’s Republic of ChinaTel +86 18713731395Fax +86 3172072825Email sarry610@163.comPurpose: The aim of this study was to assess and compare the pharmacokinetic (PK) properties and bioequivalence of montelukast sodium chewable tablets prepared by two different manufacturers in healthy Chinese volunteers to obtain adequate PK evidence for the registration approval of the test formulation.Patients and Methods: A randomized-sequence, single-dose, open-label, 2-period crossover study was conducted in fasted and fed healthy Chinese volunteers (Chinese Clinical Trials Registry identifier: CTR20182362). Eighteen subjects each were selected for a fasted study and a fed study. Eligible participants were randomly assigned in a 1:1 ratio to receive a single dose of the reference formulation or the test formulation, followed by a 5-day washout period and the administration of the alternate formulation. Plasma samples were collected over a 24-hour period following tablet administration and analyzed for montelukast contents by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The PK parameters, such as maximum serum concentration (Cmax), area under the curve (AUC) from t = 0 to the last quantifiable concentration (AUC0–t), AUC from t = 0 to infinity (AUC0–∞), half-life (t1⁄ 2), time to Cmax (Tmax), and terminal elimination rate constant (λz), were evaluated. The safety assessment included changes in vital signs (blood pressure, pulse, and temperature) or laboratory tests (hematology, blood biochemistry, hepatic function, and urinalysis) and the incidence of adverse events (AEs).Results: The geometric mean ratios (GMRs) between the two formulations for the primary pharmacokinetic parameters (Cmax, AUC0– 24, and AUC 0–∞) and the corresponding 90% confidence intervals (Cis) were all within the range of 80.00– 125.00% for both the fasting and fed states. The safety profiles for both treatments were comparable.Conclusion: The PK analysis revealed that the test and reference formulations of montelukast sodium chewable tablets were bioequivalent and well-tolerated by healthy Chinese subjects.Keywords: montelukast sodium, bioequivalence, pharmacokinetic profile, HPLC-MS/MS, adverse events

Allergic purpura, as an allergic microvascular allergic disease, mostly occurs in children. Clinical manifestations include skin purpura, joint pain, abdominal pain and kidney damage. Severe or delayed treatment may lead to gastrointestinal bleeding, renal failure and even death. In recent years, due to environmental changes, the incidence of this disease has increased year by year, and the number of children has gradually increased. At present, there is no specific medicine for children allergic purpura clinically, but a number of scholars found that the combined use of common drugs such as monoculist sodium and glucocorticoid has a good effect. On the basis of reading a large number of literatures on the combined use of western medicine in the treatment of children with allergic purpura, this paper summarizes, summarizes and summarizes them in order to provide the basis of medication and new research ideas for the combined treatment of children with allergic purpura. (过敏性紫癜作为过敏性微血管变态反应性疾病多发生于儿童, 临床以皮肤紫癜、关节痛、腹痛和肾脏损害为主要表现, 严重或延误治疗者可出现消化道出血、肾功能衰竭甚至死亡。近年来, 由于环境改变导致该病发病率逐年增高, 患儿数量也在逐渐增多。目前临床对于儿童过敏性紫癜尚无特效治疗方法, 但是多项研究发现将孟鲁司特钠、糖皮质激素等常用药物联合运用效果良好。本文在检索关于西药联合运用治疗儿童过敏性紫癜文献的基础上进行整理、归纳和总结, 以期对临床儿童过敏性紫癜联合治疗提供用药依据和研究新思路。)

Montelukast is a highly potent and selective receptor antagonist of cysteinyl leukotrienes (CysLT1) used in chronic asthma and vasoconstriction reduction and also used in allergies, swelling, hay fever, and shortness of breath. For the measurement of montelukast sodium in biological and pharmaceutical samples, there are different asynchronous and concurrent analytical methods, such as high‐performance thin layer chromatography, UV spectroscopy, capillary electrophoresis, high‐performance liquid chromatography, and liquid chromatography‐mass spectrometry, have been developed. The pathogenesis of asthma, mechanism of action, and various analytical methods for the detection of montelukast sodium and its combination of dosage forms and biological samples have been described in the present review. Ranjan et al. suggested the reverse phase high‐performance liquid chromatography approach for estimating montelukast in rabbit plasma and found the best limit of detection result of 1.0 ng/mL. Ezzeldin et al. developed a liquid chromatography with tandem mass spectrometry system for the simultaneous detection of combinations of montelukast, gliclazide, and nifedipine. The authors conclude that the studies described in the present manuscript will assist researchers in choosing a simple, rapid, and responsive method for the analysis of montelukast sodium and its combinations. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Montelukast sulphoxide impurity (MTK2) is a major oxidative degradant of drug products with Montelukast Sodium (MTK) as an active pharmaceutical ingredient (API). When such products are tested for Related Substances, they can often fail the drug product release process or shelf-life stability assessment due to concentration and out-of-specification results. Various stabilizers are used to suppress API degradation. This paper examines the influence of Cherry flavor (ChF) and its antioxidative properties on the stability of Montelukast - microcrystalline cellulose mixtures. One tablet formation was subject to detailed testing by HPLC analyses and wet chemistry (AC - Antioxidant Capacity, TFC - Total Flavonoid Content; TPC - Total Phenolic Content). Microcrystalline cellulose was found to be the main component responsible for sulphoxide impurity formation and its increase in concentration during the shelf life of the product. Our findings indicate that cherry flavor significantly affects the rate of sulphoxide impurity formation; this can be attributed to the antioxidative properties of the natural phenolics present in the cherry flavor formulation. [ABSTRACT FROM AUTHOR]

Abstract This paper introduces the first electrochemical approach for the determination of Fexofenadine hydrochloride and Montelukast sodium as a combined form by constructing three new graphite electrodes coated with a polymeric membrane. The first electrode was constructed using ammonium molybdate reagent as an ion pair with fexofenadine cation for the determination of Fexofenadine drug, the second electrode was constructed using cobalt nitrate as an ion pair with montelukast anion for the determination of Montelukast drug, the third electrode was prepared by incorporating the two previously mentioned ion pairs in the same graphite sensor, which makes this sensor sensitive to each Fexofenadine and Montelukast drug. The coating material was a polymeric film comprises of Poly Vinyl Chloride (PVC), Di-butyl phthalate as a plasticizer (DBP), ion pairs of drugs with previously mentioned reagents. The electrodes showed a Nernstian response with a mean calibration graph slopes of [59.227, 28.430, (59.048, 28,643)] mv.decade−1 for the three pencil electrodes respectively, with detection limits 0.025 μM for Fexofenadine and 0.019 μM for Montelukast drug which makes this method outperforms the reported method for the determination of this combination. The electrodes work effectively over pH range (2–4.5) for Fexofenadine hydrochloride and (5–9.5) for Montelukast sodium. The influence of the proposed interfering species was negligible as shown by selectivity coefficient values. The effectiveness of the electrodes continued in a period of time (45–69) days. The suggested sensors demonstrated useful analytical features for the determination of both drugs in bulk powder, in laboratory prepared mixtures and their combined dosage form. We have validated the method following ICH protocol, and we have reached very significant results in terms of the linearity, accuracy, selectivity, and precision of the method.

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Dissolving microneedle (MN) patches are usually formulated with a blend of drug and excipients added for mechanical strength and drug stabilization. In this study, we developed MNs made of pure drug to maximize drug loading capacity. MN patches were fabricated for transdermal delivery of montelukast sodium (MS) which is used to treat asthma and allergic rhinitis. We developed three different fabrication methods — solvent casting, melt casting, and solvent washing — and determined that filling molds with MS powder followed by a solvent washing method enabled MS to be loaded selectively to the MNs. Drug localization was confirmed with Raman imaging. MNs were able to penetrate in vitro and ex vivo skin models, and maintained strong mechanical properties during 6 months' storage at 22 °C. MS was also stable and compatible with the formulation used for the patch backing layer after 3 months' storage at 40 °C. MS delivery efficiency into skin was 55%, which enabled delivery of 3.2 mg MS into porcine skin ex vivo, which is in the range of MS doses in human clinical use. We conclude that the solvent washing method can be used to prepare MNs containing pure drug, such as MS at milligram doses in a ~ 1 cm2 MN patch. [ABSTRACT FROM AUTHOR]

Oral drug delivery is the most preferred and convenient option as the oral route provides maximum active surface area among all drug delivery system for administration of various drugs. In present work, Bilayer tablet of Acebrophylline (Sustain Release) & Montelukast Sodium (Immediate Release) were prepared by direct compression method. All trials of Acebrophylline & Montelukast Sodium and were subjected to precompression, post compression & in vitro drug release study. Bilayer tablet were prepared with passed trials of Acebrophylline & Montelukast sodium (i.e. FP-02) compared with ACEBRO-M (Marketed Product) for its pot compression parameters && in vitro drug release study. [ABSTRACT FROM AUTHOR]

Copyright of Practical Pharmacy & Clinical Remedies is the property of Editorial Department of Practical Pharmacy & Clinical Remedies 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.)

Objective: Ethyl alcohol (EA) is a substance that is used commonly worldwide and known to have toxic effects on the liver. The aim of this study was to investigate the effect of montelukast sodium (MK) on acute hepatopathy induced by a single dose of EA in rats. Methods: The study consisted of four groups each containing eight Wistar albino male rats. The groups were classified as follows: the control group received distilled water; the EA group received 6 g/kg EA diluted with distilled water orally by gavage; the MK group received 30 mg/kg MK orally by gavage; the EA + MK group received, 2 hours after the EA administration, ie 30 mg/kg MK orally by gavage. After 24 hours, all the rats were sacrificed, and their blood and liver tissue samples were taken for biochemical and histopathological examinations. Results: The administration of EA caused a statistically significant increase in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels compared with the control group (220.50 ± 66.90 and 92.38 ± 5.90 versus 84.88 ± 15.66 and 43.75 ± 10.22). The administration of EA + MK caused a statistically significant decrease in the AST and ALT levels compared with the EA alone group. Ethyl alcohol administered to the rats caused lesion in the liver including congestions, hydropic degeneration and irregular shaped area caused coagulation necrosis. The histopathological changes seen in the EA group were not detected in the EA + MK group. Conclusion: Consequently, these data suggested that MK had beneficial effects in alleviating EA-induced hepatotoxicity in rats. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To systematically evaluate the efficacy and safety of montelukast sodium combined with azelastine hydrochloride in the treatment of allergic rhinitis. METHODS: PubMed, CNKI, the Cochrane Library, EMBase and Wanfang database were retrieved to collect the randomized controlled trial of montelukast sodium combined with azelastine hydrochloride in the treatment of allergic rhinitis ( the study group was treated with montelukast sodium combined with azelastine hydrochloride, while the control group received azelastine hydrochloride alone, without limitation of usage and dosage). The retrieval time was from the establishment of the database to Mar. 2021. Meta-analysis was performed by using RevMan 5. 4 software after data extraction by two researchers, selection of literature, and evaluation of risk of bias in the included literature. RESULTS: Totally 13 randomized controlled trials were collected, including 2 659 patients ( 1 330 patients in the study group and 1 329 patients in the control group) . Meta-analysis showed that in terms of effectiveness, the total effective rate ( OR = 6. 25, 95% CI= 4. 52-8. 65, P < 0. 000 01), significant effective rate ( OR= 2. 36, 95% CI= 1. 85-3. 01, P < 0. 000 01) and recurrence rate ( OR= 0. 30, 95%CI = 0. 14-0. 65,P = 0. 002) in the study group were significantly better than those in the control group, and the differences were statistically significant. There was no significant difference in the incidence of adverse drug reactions between two groups (OR= 1. 19,95%CI= 0. 52-2. 71,P= 0. 69>0. 05). CONCLUSIONS: Available evidence suggests that montelukast sodium in combination with azelastine hydrochloride is safe and effective in the treatment of allergic rhinitis, with significant advantages over the use of azelastine hydrochloride alone. Due to the limited number and quality of selected literature, the above conclusions need to be verified by more high-quality randomized controlled trials in the future. [ABSTRACT FROM AUTHOR]

Background: The goal of this research was to use the Quality by Design (QbD) approach to develop orally disintegrating tablets of Montelukast sodium, a leukotriene receptor antagonist used to treat asthma. Characterizing the reference product, defining the quality target product profile (QTPP), identifying critical quality attributes (CQAs), and performing initial testing are all parts of the QbD approach and relating the critical material attributes (CMAs) and critical process parameter (CPP) to drug product CQAs, as a result to develop the design space and defining control strategy. Method: Montelukast sodium tablets were designed using direct compression technique. Formulation were designed by using (DOE software v 13.2) 23 full factorial design in which three variables namely croscarmellose sodium (CCS), microcrystalline cellulose (MCC) and magnesium stearate were varied at two levels by considering one center point. Results: The disintegration time and in vitro dissolution were considered as responses and the prepared tablets have been evaluated for various quality control tests. Formulation F5 was considered as optimized as it showed minimum disintegration time and maximum drug release profile. Conclusion: The CMAs classified as high or medium risk in the initial risk assessment were mitigated to low risk based on the experimentation. Finally, a control strategy was defined giving better control over drug product development. [ABSTRACT FROM AUTHOR]

The main aim is to develop a simple, rugged, and sensitive method for determining the Montelukast Sodium-related impurities in a tablet dosage form using reverse-phase high-performance liquid chromatography (RP-HPLC) method. Chromatographic separation on the Agilent Eclipse XDB C18 (octadecylsilane) column of the dimension (100 mm × 4.6 mm, 5 µm) was carried out in the gradient mode with triethylamine and acetonitrile in various combinations and adjusted to a pH of 6.60 using phosphoric acid. The mobile phase was pumped at a flow rate of 1.0 mL min−1 and the analyte was monitored with a UV detector at a wavelength of 220 nm. The method was developed and validated under the stress conditions such as acidic, basic, peroxide, thermal, photolytic, and humidity degradation, respectively. Under the above conditions, oxidative degradation was performed which served as the system suitability solution providing a resolution of 2.5 between the Impurity 3 (retention time = 13.8 min) and Montelukast Sodium (retention time = 24.2 min). The method was validated with respect to specificity, linearity, precision, accuracy, limit of detection, and limit of quantification provided by the ICH guidelines. Results of linear regression analysis of the calibration plot revealed a good linear relationship between response and concentration with a correlation coefficient value of r2 = 0.9999. The accuracy of known impurities was obtained in the range of 94–108%. From the analysis, their LOD and LOQ values for impurities were measured and found to be 0.007 and 0.025 μg g−1, respectively. Chromatographic interference was not found during the degradation and excipients were detected from the tablet. The proposed method was successfully used to estimate the Montelukast Sodium-related impurities in a tablet dosage form. [ABSTRACT FROM AUTHOR]

Background & Objectives: Generally, the blockage of upper respiratory tract in children is seen with the hypertrophy of adenoids and tonsils. Normally for patients with adenoid hypertrophy (AH), Adenoidectomy with or without Tonsillectomy is carried out, however it has its own complications like haemorrhage and recurrence of adenoid tissue. Consequently, therapeutic approach has increased extraordinary consideration rather than surgical procedure. The inflammatory process proposed for AH has prompted the utilization of anti-inflammatory drugs to treat this issue. The objective of this study was to assess the impacts of Montelukast sodium in children with enlarged adenoids. Methods: A randomized controlled trail was performed from April 2018 to March 2019 in the Otorhinolaryngology clinic of Dr. Akbar Niazi Teaching Hospital, Islamabad. In this randomized, placebo treatment-controlled trial, 60 children aged 4-12 years meeting inclusion criteria were isolated into two groups. The study group was treated with Montelukast sodium 5mg consistently for three months while the control group got placebo treatment for a similar timeframe. A questionnaire was filled by parents/ guardians of every child before and after the intervention to evaluate the severity of sleep discomfort, snoring and mouth breathing. Results: Following 3 months of treatment, significant reduction in size of the adenoids was seen in 76% of study group compared with just 3% of control group getting placebo treatment. Conclusion: Montelukast sodium seems to be effective in the reduction of the size of adenoids and improvement in clinical manifestations. It can be viewed as a viable option in contrast to surgical treatment in children with hypertrophy of adenoids. [ABSTRACT FROM AUTHOR]