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孟鲁司特与左西替利嗪的复方制剂:聚焦双层技术。

FDC of montelukast with levocetirizine: focus on bilayer technology.

作者信息

Rathod R T, Misra D

机构信息

German Remedies Division, Cadila Healthcare Limited, Mumbai 400018. [corrected]

出版信息

J Indian Med Assoc. 2009 Aug;107(8):562-4.

PMID:20112841
Abstract

Allergic rhinitis is the most common allergic disease worldwide and affects about 18% to 40% of the general population. Anti-allergic medicines (eg, some antihistamines) can cause adverse events such as somnolence and can have an additional negative impact on quality of life. Combining montelukast with levocetirizine gives additional benefits in comparison with either drug alone and could be considered for patients whose quality of life is impaired by persistent allergic rhinitis. Montelukast sodium is alkaline, stable and levocetirizine dihydrochloride is acid stable, when we prepare a matrix tablet, both the drugs would be in contact and make it unstable during the shelf life of the formulation. Hence it is recommended to prepare bilayer tablet, as it improves and increases the stability of both the drugs in combination. Bilayer tablet of montelukast with levocetirizine is more stable with respect to stability studies, in comparison to matrix tablet.

摘要

变应性鼻炎是全球最常见的变应性疾病,影响约18%至40%的普通人群。抗过敏药物(如某些抗组胺药)可引起嗜睡等不良事件,并会对生活质量产生额外的负面影响。与单独使用任何一种药物相比,孟鲁司特与左西替利嗪联合使用具有额外的益处,对于因持续性变应性鼻炎而生活质量受损的患者可考虑使用。孟鲁司特钠呈碱性且稳定,而盐酸左西替利嗪呈酸稳定,当我们制备骨架片时,两种药物会接触并在制剂的保质期内使其不稳定。因此,建议制备双层片,因为它可提高并增强两种药物联合使用时的稳定性。与骨架片相比,孟鲁司特与左西替利嗪的双层片在稳定性研究方面更稳定。

相似文献

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FDC of montelukast with levocetirizine: focus on bilayer technology.孟鲁司特与左西替利嗪的复方制剂:聚焦双层技术。
J Indian Med Assoc. 2009 Aug;107(8):562-4.
2
Quality of life in patients with persistent allergic rhinitis treated with montelukast alone or in combination with levocetirizine or desloratadine.单用孟鲁司特或联合左西替利嗪或地氯雷他定治疗持续性变应性鼻炎患者的生活质量
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Use of montelukast alone or in combination with desloratadine or levocetirizine in patients with persistent allergic rhinitis.在持续性变应性鼻炎患者中使用孟鲁司特单独治疗或与地氯雷他定或左西替利嗪联合治疗。
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Long term treatment with montelukast and levocetirizine combination in persistent allergic rhinitis: review of recent evidence.孟鲁司特与左西替利嗪联合用于持续性变应性鼻炎的长期治疗:近期证据综述
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Nasal eosinophilia and serum soluble intercellular adhesion molecule 1 in patients with allergic rhinitis treated with montelukast alone or in combination with desloratadine or levocetirizine.孟鲁司特单药治疗与联合地氯雷他定或左西替利嗪治疗变应性鼻炎患者的鼻嗜酸粒细胞计数和血清可溶性细胞间黏附分子-1。
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Comparison of the pharmacokinetics and tolerability of montelukast/levocetirizine administered as a fixed-dose combination and as separate tablets.孟鲁司特/左西替利嗪以固定剂量组合和单独片剂给药时的药代动力学和耐受性比较。
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Letter in response to "Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial" by Sarkar .致萨卡尔所著《左西替利嗪10毫克与左西替利嗪5毫克联合孟鲁司特10毫克治疗对5毫克左西替利嗪耐药的慢性荨麻疹的有效性和安全性:一项双盲、随机、对照试验》的回应信
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引用本文的文献

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The Development of Innovative Dosage Forms of the Fixed-Dose Combination of Active Pharmaceutical Ingredients.活性药物成分固定剂量组合的创新剂型研发
Pharmaceutics. 2022 Apr 11;14(4):834. doi: 10.3390/pharmaceutics14040834.
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Does Separate Administration of Montelukast and Levocetirizine Provide Better Results in Perennial Allergic Rhinitis: A Hospital Based Study.孟鲁司特和左西替利嗪分开给药在常年性变应性鼻炎中效果更佳:一项基于医院的研究
Indian J Otolaryngol Head Neck Surg. 2019 Nov;71(Suppl 3):1674-1678. doi: 10.1007/s12070-015-0910-z. Epub 2015 Sep 22.