Estudio de bioequivalencia de Montelukast tabletas masticables de 5 mg

Medina, Angela Piedad; Olaya, Francisco Javier; Navas, Mónica Patricia; Tilano, Ángela María; Muñoz, E. Vázquez

doi:10.7705/biomedica.v32i3.708

Cited by 6 publications

(2 citation statements)

References 18 publications

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“…14,15 A relevant study show that the pharmacodynamics of montelukast tends to be stable within one day without tolerance, and it can effectively relieve cough, asthma and other uncomfortable symptoms. 16 Rajanandh et al found that the therapeutic effect of therapy of budesonide/formoterol combined with montelukast was significant in the treatment of asthma, superior to other combined therapies, and the patients had good tolerance. 17 The results of this study also suggested that the total effective rate and the improvement of pulmonary function of the observation group treated with budesonide/ formoterol and montelukast were better than those of the control group, which were in line with the above results.…”

Section: Discussionmentioning

confidence: 99%

Budesonide/Fomoterol in combination with Montelukast in the treatment of Bronchial Asthma

et al. 2020

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Objective: To analyze the clinical effect of budesonide/fomoterol combined with montelukast in the treatment of chronic persistent asthma. Methods: Ninety-four patients with asthma who came to our hospital for treatment from April 2017 to April 2019 were randomly divided into control group and observation group, with 47 patients in each group. The control group was treated with budesonide/formoterol, and the observation group was treated with montelukast on the basis of the control group. The treatment effect of the two groups was observed and compared. Results: The total efficacy rate of the observation group was significantly higher than that of the control group (P<0.05); the daytime symptom score and nighttime symptom score of the observation group were significantly higher than those of the control group (P<0.05). The pulmonary function indexes of the two groups after treatment were significantly higher than that before treatment, and the improvement of the observation group was more significant (P<0.05); the FeNO and EO levels of the observation group after treatment were superior to those of the control group, and the difference was statistically significant (P<0.05). Conclusion: Budesonide/formoterol powder inhalation combined with montelukast can effectively improve the lung function, reduce the level of inflammatory factors, and accelerate the regression of symptoms in the treatment of chronic persistent asthma. It is worth clinical application. doi: https://doi.org/10.12669/pjms.36.7.2018 How to cite this:Dai X, Feng T, Zhang X, Li K. Budesonide/Fomoterol in combination with Montelukast in the treatment of Bronchial Asthma. Pak J Med Sci. 2020;36(7):---------. doi: https://doi.org/10.12669/pjms.36.7.2018 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.

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Section: Discussionmentioning

confidence: 99%

Budesonide/Fomoterol in combination with Montelukast in the treatment of Bronchial Asthma

et al. 2020

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“…[1][2][3] Allegra-M the highly effective dosage regimen to treat allergies is composed of Fexofenadine hydrochlor ide, the second generation antihistamine chemically known as "(±)-4-[1hydroxy-4-[4-(hydroxydiphenylmethyl) -1-piperidinyl]-butyl]-a,a-dimethyl benzeneacetic acid hydrochloride" which functions by antagonizing H1 receptor and Monteleukast sodium which is non cysteinyl leukotriene receptor antagonist with the chemical name" [R-(E)]-1-[[ [1-[3-[2-(7-chloro-2quinolinyl)ethenyl]phenyl]-3-[2-(1hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneaceticacid,mono sodi um salt." [4][5][6] The tablet is composed of 120 mg of fexofenadine and 10 mg of monteleukast sodium. The 12:1 ratio of drugs in the dosage form imposes quite a challenge to the analytical chemist in developing a compatible method for the simultaneous estimation of two drugs.…”

Section: Introductionmentioning

confidence: 99%

Concurrent Discriminative Emission Intensity Quantification of Fexofenadine hydrochloride and Montelukast Sodium

et al. 2022

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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 261 nm and 287 nm for Fexofenadine Hydrochloride and 392 nm 487 nm 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.

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Novel montelukast sodium-loaded clear oral solution prepared with hydroxypropyl-β-cyclodextrin as a solubilizer and stabilizer: enhanced stability and bioequivalence to commercial granules in rats

Kim

Kwon

et al. 2015

J Incl Phenom Macrocycl Chem

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To develop a montelukast sodium-loaded clear oral solution with enhanced stability that was bioequivalent to commercial granules in rats for the treatment of asthma, various montelukast sodium-loaded solutions were prepared with various amounts of solubilizers and stabilizer, and their solubility and stability were investigated. Furthermore, the dissolution and pharmacokinetic studies were carried out in rats with the optimised formulation and the commercial montelukast sodium-loaded granules. Among the solubilizers tested in this study, hydroxypropyl-b-cyclodextrin (HP-b-CD) was selected because it greatly improved the drug solubility and stability. Furthermore, EDTA sodium was used as a stabilizer because it gave excellent stability. In particular, the montelukast-loaded oral solution, an aqueous clear solution containing montelukast sodium, HP-b-CD, methylparaben sodium, propylparaben sodium and EDTA sodium at w/v percentages of 1.04/156/1.8/0.2/1, gave similar dissolution to the commercial granules in 0.5 % (w/v) sodium lauryl sulphate in water, FDA-regulated dissolution medium. This oral solution gave similar plasma concentrations and pharmacokinetic parameters to the commercial granules, suggesting that it was bioequivalent to the commercial granules in rats. Moreover, it was physically and chemically stable at 25°C/60 % RH and 40°C/75 % RH for at least 12 months. Thus, this oral solution is strongly recommended as an alternative to the oral montelukast-loaded product for the treatment of asthma.

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Estudio de bioequivalencia de Montelukast tabletas masticables de 5 mg

Cited by 6 publications

References 18 publications

Budesonide/Fomoterol in combination with Montelukast in the treatment of Bronchial Asthma

Budesonide/Fomoterol in combination with Montelukast in the treatment of Bronchial Asthma

Concurrent Discriminative Emission Intensity Quantification of Fexofenadine hydrochloride and Montelukast Sodium

Novel montelukast sodium-loaded clear oral solution prepared with hydroxypropyl-β-cyclodextrin as a solubilizer and stabilizer: enhanced stability and bioequivalence to commercial granules in rats

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