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1

Dr., Gampa Vijay Kumar Dr.T.Rajesh Jaya Chandhra. "A STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTAENOUS ESTIMATION OF MONTELUKAST AND FEXOFENADINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 12 (2018): 16756–65. https://doi.org/10.5281/zenodo.2505290.

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<em>A new method was established for simultaneous estimation of Fexofenadine Hcl and Montelukast by RP-HPLC method.&nbsp; The &nbsp;chromatographic conditions were successfully developed for the separation of Fexofenadine Hcl &nbsp;and Montelukast by using Xterra C18 5&micro;m (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN&nbsp; &nbsp;(55:45%v/v)&nbsp; &nbsp;(pH&nbsp; &nbsp;was&nbsp;&nbsp; adjusted&nbsp; &nbsp;with&nbsp; &nbsp;orthophosphoric&nbsp; &nbsp;acid), detection wave length was 255nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution.The retention times were found to be 2.399mins and 3.907mins. The % purity of Fexofenadine Hcl &nbsp;and Montelukast was found to be 100.7% and 101.4% respectively. The system suitability parameters for Fexofenadine Hcl &nbsp;and Montelukast such as theoretical plates and tailing factor were found to be 1.3, 5117.5and 1.4, 3877.3 the resolution was found to be 8.0.The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Fexofenadine Hcl &nbsp;and Montelukast was found&nbsp; &nbsp;in&nbsp; &nbsp;concentration&nbsp; &nbsp;range&nbsp;&nbsp; of&nbsp; &nbsp;1&mu;g-5&mu;g&nbsp; &nbsp;and&nbsp; &nbsp;100&mu;g-500&mu;g&nbsp;&nbsp; and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, % RSD for intermediate precision was 0.5 and 0.1 respectively. &nbsp;The &nbsp;precision &nbsp;study &nbsp;was precise, &nbsp;robust,&nbsp; and &nbsp;repeatable. LOD value was 2.95 and 3.04, and LOQ value was 9.87 and 10 respectively. </em> <strong>Keyword:</strong> <em>Fexofenadine Hcl </em>&nbsp;<em>an</em><em>d Montelukast, RP-HPLC method</em>
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Mustafa, Mohamed, S. Amuthalakshmi, and C. N. Nalini. "Simultaneous UPLC Estimation of Fexofenadine HCl and Montelukast Sodium Tablets." Research Journal of Pharmacy and Technology 10, no. 2 (2017): 557. http://dx.doi.org/10.5958/0974-360x.2017.00111.1.

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Narang, Anuj, Usha Y. Nayak, Bisakha Roy, and Reema Narayan. "Formulation Design of Bilayer Dual-Release Tablet composition of Fexofenadine HCl and Montelukast Sodium." Research Journal of Pharmacy and Technology 9, no. 9 (2016): 1410. http://dx.doi.org/10.5958/0974-360x.2016.00273.0.

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4

S., Manjula, and Krishna Kumar M. "Expert perspectives on the prescription pattern of levocetirizine₊montelukast and fexofenadine₊montelukast for the management of allergic rhinitis in the Indian settings." International Journal of Otorhinolaryngology and Head and Neck Surgery 10, no. 5 (2024): 481–86. http://dx.doi.org/10.18203/issn.2454-5929.ijohns20242702.

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Background: Studies have shown that oral antihistamines are considered as the gold-standard therapy for allergic rhinitis. However, there is dearth of studies among clinicians, so this study aimed to gather expert opinion on the prescribing pattern of levocetirizine₊montelukast and fexofenadine₊montelukast for managing AR in India. Methods: This cross-sectional study, conducted through a multi-response questionnaire comprising 24 questions, gathered insights from experts across diverse Indian settings. It explored perspectives on clinical observations, experiences, demographic profiles, treatment characteristics in AR, and the utilization of fexofenadine₊montelukast and levocetirizine₊montelukast for AR management in clinical practice. The data were analyzed through descriptive analysis. Results: Majority of clinicians (52%) preferred levocetirizine₊montelukast for AR, with half of them recommending a 2-week course. Additionally, 38% of clinicians noted its effectiveness in addressing all AR symptoms. Most clinicians agreed that levocetirizine and montelukast combination therapy was effective in improving nighttime nasal symptoms (74%) and nasal congestion (69%). Furthermore, majority of clinicians acknowledged that the combination offers both immediate (74%) and long-term (56%) relief from AR symptoms. Approximately 58% of the healthcare providers reported overall improvement across categories with fexofenadine₊montelukast, encompassing daytime nasal symptoms, nighttime nasal symptoms, and daytime eye symptoms. Conclusion: Clinicians recommended the combination of levocetirizine₊montelukast and fexofenadine₊montelukast to manage AR. Levocetirizine₊montelukast combination was preferred by clinicians for its efficacy in alleviating nighttime nasal symptoms and congestion. Fexofenadine₊montelukast combination was also endorsed for overall improvement across various symptoms.
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Anumolu, Panikumar Durga, Pulusu Veera Shakar, Jampana Rama Tulasi, Chaganti Soujanya, Syed Sara Afreen, and Gorja Ashok. "Concurrent Discriminative Emission Intensity Quantification of Fexofenadine hydrochloride and Montelukast Sodium." Oriental Journal Of Chemistry 38, no. 6 (2022): 1364–68. http://dx.doi.org/10.13005/ojc/380605.

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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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Thapa, Shankar, Bipindra Pandey Pandey, and Mahalakshami Suresha Biradar. "Analytical Method Development and Validation of Simultaneous Estimation of Pure and Tablet Dosage Form by RP-HPLC." Journal of Nepal Chemical Society 44, no. 2 (2024): 13–22. http://dx.doi.org/10.3126/jncs.v44i2.68298.

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The aim of this analytical research is to establish and validate the RP-HPLC (Reverse Phase High Performance Liquid Chromatography) method for concurrently quantifying Montelukast Sodium, Fexofenadine Hydrochloride, and Acebrophylline in a pharmaceutical formulation. The method utilized Rosagiline mesylate as an internal standard, employing a Shim-Pack Solar C18 Column (4.6 x 150 mm, 5 µm) as the stationary phase and a mobile phase composed of acetonitrile, methanol, and 10 mM Na2HPO4 buffer (50:30:20 % v/v/v, pH 5.5). The flow rate was maintained at 1.0 mL/min, and detection occurred at 210 nm. Validation followed ICH guidelines. The linear concentration ranges were 5-30 µg/ml, 10-60 µg/ml, and 10-100 µg/ml at 210 nm for Montelukast Sodium, Fexofenadine Hydrochloride, and Acebrophylline, respectively. Retention times were 7.643 min, 2.117 min, 3.863 min, and 3.050 min for Montelukast sodium, Fexofenadine Hydrochloride, Acebrophylline, and Rosagiline mesylate respectively. The RP-HPLC analysis of marketed formulations yielded concentrations within the ranges of 98.3–100.9%, 99.46–101.23%, and 99.82–101.74% for Montelukast sodium, Fexofenadine Hydrochloride, and Acebrophylline, respectively. Recovery fell within the range of 95.81-101.35% for both drugs. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of Montelukast, Fexofenadine and Acebrophylline in their combined tablet dosage form.
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Manjula, S., and M. Krishna Kumar. "Expert opinion on the prescription practice of antihistamines for the management of allergic rhinitis in Indian settings." IP Journal of Otorhinolaryngology and Allied Science 6, no. 4 (2024): 108–12. http://dx.doi.org/10.18231/j.ijoas.2023.025.

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Several clinical studies corroborate the synergistic effects of montelukast in conjunction with antihistamine for reducing the symptoms and quality of life of AR patients. Some studies also highlighted a significant quantitative differences in the prescribing patterns of antihistamines across different countries. So, this study aimed to gather expert opinions on the management of allergic rhinitis (AR) using antihistamines alone or in various combinations in Indian settings.The cross-sectional, multiple-response, 23-item survey was primarily focused on current practices, clinical observations, and experiences related to AR and the utilization of oral histamines for disease management. The study involved otorhinolaryngologist from diverse settings in India.Out of 435 participants, 29% reported sneezing as the common AR symptoms. The majority (84.83%) favoured antihistamine and leukotriene receptor antagonist combinations for AR treatment. Specifically, 52% preferred levocetirizine, while 43% favoured fexofenadine. About 63% opted for polytherapy with oral antihistamines and anti-leukotrienes for AR management. Of these, 48% chose levocetirizine and montelukast for various AR symptoms. According to 60% of participants, fexofenadine + montelukast effectively improved nasal and eye symptoms. Around 64% preferred levocetirizine + montelukast for nighttime nasal symptoms, while 55% chose fexofenadine + montelukast for daytime nasal symptoms. Around 64% of the respondents favoured levocetirizine + montelukast for improving all AR symptoms, and 69% favoured antihistamine + montelukast for its cost-effectiveness.Experts recommend antihistamine and leukotriene receptor antagonist combinations for managing AR symptoms, with levocetirizine and fexofenadine being popular choices. Polytherapy with these combinations was favoured, especially for managing nighttime and daytime nasal symptoms.
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Piñeyro-Garza, Everardo, Magdalena Gómez-Silva, María Elena Gamino-Peña, Vanessa Cohen-Muñoz, Gabriela Sánchez-Casado, and Ella Palmer. "Bioavailability assessment of fexofenadine and montelukast in a fixed-dose combination tablet versus the components administered simultaneously." Allergologia et Immunopathologia 49, no. 4 (2021): 15–25. http://dx.doi.org/10.15586/aei.v49i4.89.

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Introduction and Objectives: Allergic rhinitis is a condition with high global prevalence most effectively treated with antihistamines and antileukotrienes. This study aimed to evaluate the bioequivalence of fexofenadine and montelukast in a fixed-dose combination tablet versus the components administered simultaneously.Materials and Methods: An open, randomized, 2×2 crossover study was performed in 78 healthy volunteers. Fexofenadine–montelukast tablets containing 120 mg and 10 mg, respectively, were used as the test treatment, and 120 mg fexofenadine tablets and 10 mg montelukast tablets were used as the reference treatment. Concentrations of fexofenadine and montelukast in plasma were determined by protein precipitation and analysis by liquid chromatography/mass spectrometry or liquid chromatography tandem mass spectrometry.Results: The 90% confidence intervals (CIs) obtained for fexofenadine were 87.612–102.144 for area under the curve of the plasma concentration after administration to the last concentration (AUC0-t), 88.471–102.282 for the AUC of the plasma concentration extrapolated to infinity (AUC0–∞), and 91.413–108.544 for the maximum plasma concentration (Cmax). For montelukast, they were 96.418–108.416 for AUC0-t, 93.273–106.642 for AUC0-∞ and 94.749–110.178 for Cmax. The ratio and CIs of the values subjected to logarithmic transformation for each parameter were within the range of acceptability of 80%–125%, demonstrating the bioequivalence of the combined fixed-dose tablet to the components administered separately at the same doses. No adverse events were recorded during the study.Conclusions: This study has shown the bioequivalence of the combined fixed-dose tablet, which may be considered a new alternative for the treatment of allergic rhinitis.
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Haleem, Kainat, Safiullah Khan, Shahzada Khurram Syed, and Saif Ur Rehman. "Development of gastro retentive microbeads for sustained release of fexofenadine and montelukast." Journal of Contemporary Pharmacy 5, no. 1 (2021): 16–27. http://dx.doi.org/10.56770/jcp2021513.

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In allergic rhinitis, montelukast (leukotriene receptor antagonist) in combination with fexofenadine (antihistamine) provide improved and complimentary effects and reduce the allergic symptoms effectively. Montelukast has less bioavailability due to hepatic first pass metabolism and fexofenadine have low permeability. So sustained release delivery is crucial for these drugs. One of the techniques to overcome this challenge is the development of polymeric microspheres or microbeads for enhanced bioavailability and prolong the action of drug in body. The objective of the study is to produce a potential microencapsulated formulation having the combination of fexofenadine hydrochloride and montelukast sodium. Microbeads were formulated by using polymer, eudragit RS100. Single emulsion solvent evaporation method was used for the preparation of formulation. The developed drug loaded polymeric microbeads showed that percentage floating ranged from 82.1 - 90.4%. Entrapment efficiency of microbeads were found between 68.8- 80.9%. FTIR results revealed absence of drug-polymer interaction. In-vitro release studies shown that from all the prepared formulations of both drugs the optimum formulation was released up to 24hrs and percentage cumulative drug release was 87.40% and 89.78% respectively. The acute toxicity study showed the safety of the developed system. Formulated microbeads were significantly efficient to achieve a sustained release of fexofenadine and montelukast with prolonged therapeutics release up to 24 hours. The developed gastro retentive floating drug delivery systems showed excellent physicochemical properties and sustained drug release pattern, thereby improving the bioavailability of the drugs.
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Asma, Shaikh, Sonali Gholap Dr., Gadia Varun, and Mullick Arina. "Establishing the Efficacy of Fexofenadine and Montelukast Combination Therapy in Allergic Rhinitis Management." International Journal of Healthcare Sciences 12, no. 1 (2024): 129–30. https://doi.org/10.5281/zenodo.13739685.

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<strong>Abstract:</strong> Allergic rhinitis (AR) is an atopic disease characterized by symptoms such as sneezing, nasal congestion, clear rhinorrhea, and nasal pruritus. This study investigates the efficacy of a combination therapy using Fexofenadine Hydrochloride 120 mg and Montelukast Sodium 10 mg in managing AR. Leveraging an omnichannel marketing campaign on the Hidoc Dr platform, the study targeted healthcare professionals through digital channels like mobile apps, websites, emails, SMS, and tele-calling services. The campaign aimed to establish this combination therapy as a preferred choice among physicians. The results revealed significant engagement, with 166,606 healthcare professionals reached, 2,884,308 impressions, and 462,546 clicks. The campaign demonstrated a 16% click-through rate and generated 105 high-quality leads, confirming the increased preference and usage of the combination therapy for AR treatment. <strong>Keywords:</strong> Allergic Rhinitis, Fexofenadine, Montelukast, Combination Therapy, Omnichannel Marketing, Healthcare Professionals, Engagement Metrics, Hidoc Dr. <strong>Title:</strong> Establishing the Efficacy of Fexofenadine and Montelukast Combination Therapy in Allergic Rhinitis Management <strong>Author:</strong> Asma Shaikh, Dr. Sonali Gholap, Varun Gadia, Arina Mullick <strong>International Journal of Healthcare Sciences</strong> <strong>ISSN 2348-5728 (Online)</strong> <strong>Vol. 12, Issue 1, April 2024 - September 2024</strong> <strong>Page No: 129-130</strong> <strong>Research Publish Journals</strong> <strong>Website: www.researchpublish.com</strong> <strong>Published Date: 10-September-2024</strong> <strong>DOI: https://doi.org/10.5281/zenodo.13739685</strong> <strong>Paper Download Link (Source)</strong> <strong>https://www.researchpublish.com/papers/establishing-the-efficacy-of-fexofenadine-and-montelukast-combination-therapy-in-allergic-rhinitis-management</strong>
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Kaur, Gurpreet, Rachna Dhingra, and Manjinder Singh. "Comparative Study to Assess Clinical Efficacy of Leukotriene Receptor Antagonist and Antihistamines in the Treatment of Allergic Rhinitis." Bengal Journal of Otolaryngology and Head Neck Surgery 25, no. 2 (2017): 81–88. http://dx.doi.org/10.47210/bjohns.2017.v25i2.118.

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Introduction &#x0D; Pharmacologic treatment options for allergic rhinitis include intranasal corticosteroids, oral and topical antihistamines, decongestants, intranasal cromolyn, intranasal anticholinergics and leukotriene receptor antagonists. The present study was undertaken to compare the efficacy of leukotriene receptor antagonist and antihistamines in relieving nasal congestion/ obstruction symptom and itching /irritation in eyes.&#x0D; Material and Methods &#x0D; The study was conducted among 125 patients clinically diagnosed suffering from allergic rhinitis Patients were divided into 5 groups and were given oral treatment with oral antihistamines (chlorpheniramine maleate, levocetrizine, fexofenadine, desloratadine) and leukotriene receptor antagonist (montelukast) for a period of 6 weeks. The results were tabulated and analyzed by Chi-square and Kruskal-Wallis test with p value &lt;0.05 as significant value.&#x0D; Result&#x0D; For relieving nasal obstruction, levocetrizine group showed maximum improvement at 2 weeks. However, at the end of 6 weeks montelukast group showed maximum relief followed by levocetrizine and desloratidine. In relieving eye itching/irritation, montelukast and levocetirizine were equally effective. Fexofenadine and desloratadine were less effective in relieving nasal obstruction and eye itching/irritation followed by chlorpheniramine maleate, which was least effective.&#x0D; Conclusion&#x0D; Allergic rhinitis affects the social and professional life of patient. Allergen avoidance should be the initial step in the management of allergic rhinitis. Montelukast and levocetirizine are more effective in relieving nasal obstruction and eye itching/irritation compared to fexofenadine, desloratadine and chlorpheniramine maleate.
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&NA;. "Fexofenadine/pseudoephedrine comparable to loratadine/montelukast combo." Inpharma Weekly &NA;, no. 1424 (2004): 5. http://dx.doi.org/10.2165/00128413-200414240-00011.

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Hirendra, Kumar, Suresh Keshava Pant, and Kumar Dinesh. "Monteleukast and Levocetirizine Vs Monteleukast Fexofenadine in Allergic Rhinitis Cases: A Comparative Analysis." International Journal of Pharmaceutical and Clinical Research 15, no. 6 (2023): 2049–53. https://doi.org/10.5281/zenodo.12530853.

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<strong>Background:&nbsp;</strong>An issue with the world&rsquo;s health is allergic rhinitis (AR). It is the main cause of serious illness and disability. In cases of allergic rhinitis, the current study examined Monteleukast, Levocetirizine, and Monteleukast Fexofenadine.&nbsp;<strong>Methods:&nbsp;</strong>The 40 allergic rhinitis patients in the current study were split evenly between the sexes. Twenty patients each were placed into two groups. Patients in group I received a fixed-dose combination of montelukast 10 mg and levocetirizine 5 mg once daily, whereas patients in group II received a fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg once daily.&nbsp;<strong>Results:&nbsp;</strong>At baseline, group I mean TNSS was 11.4, at two weeks, it was 5.24, and at four weeks, it was 3.28. In group I, the mean TNSS was 10.5, 4.06 at two weeks, and 1.16 at four weeks. At the second and fourth weeks, the cost-effectiveness ratio in group I was considerably lower than in group II (P &lt;0.05). Three patients in group I and one in group II had nausea, while group I saw one sedation case and three in group II experienced dry mouth. The distinction was noteworthy (P &lt;0.05).&nbsp;<strong>Conclusion:&nbsp;</strong>In patients with allergic rhinitis, we discovered that the montelukast-levocetirizine group performed better than the montelukast-fexofenadine group. &nbsp; &nbsp; &nbsp;
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Pratt, C., A. M. Brown, D. Rampe, et al. "Cardiovascular safety of fexofenadine HCl." Clinical & Experimental Allergy 29 (July 1999): 212–16. http://dx.doi.org/10.1046/j.1365-2222.1999.0290s3212.x.

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CHRISTEENA MARY VIJI, THOMAS JACOB ABRAHAM, and HARIKRISHNAN S. "A case report on montelukast and fexofenadine induced depression and nightmares." World Journal of Biology Pharmacy and Health Sciences 21, no. 2 (2025): 111–13. https://doi.org/10.30574/wjbphs.2025.21.2.0114.

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Depression and nightmares are caused by Montelukast. Montelukast is a selective leukotriene receptor antagonist (LRTA) and US-FDA issued a black box warning in 2020. In this case report, a 14 year old female was prescribed a combination of Tab. Montelukast and Tab. Fexofenadine for the treatment of bronchial asthma exacerbations. After this, she started experiencing multiple episodes of depression and nightmares. The patient was asked to avoid Montelukast after which the patient's condition improved and she was started on MDI Formoterol fumarate and Budesonide powder for inhalation and Tab. Desloratadine for further management. After stopping the drug, her condition improved. This case report underlines the importance of monitoring for rare but serious side effects of leukotriene receptor antagonist and highlights the need for further research into their mechanisms and risk factors.
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Nasr, Ali M., Mona K. Qushawy, Mahmoud M. Elkhoudary, Aya Y. Gawish, Sameh S. Elhady, and Shady A. Swidan. "Quality by Design for the Development and Analysis of Enhanced In-Situ Forming Vesicles for the Improvement of the Bioavailability of Fexofenadine HCl In Vitro and In Vivo." Pharmaceutics 12, no. 5 (2020): 409. http://dx.doi.org/10.3390/pharmaceutics12050409.

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Drug absorption from the gastrointestinal tract (GIT) is one of the major problems affecting the bioavailability of orally absorbed drugs. This work aims to enhance Fexofenadine HCl oral bioavailability in vivo, the drug used for allergic rhinitis. In this study, novel spray-dried lactose-based enhanced in situ forming vesicles were prepared using different absorption enhancer by the slurry method. Full factorial design was used to obtain an optimized formulation, while central composite design was used to develop economic, environment-friendly analysis method of Fexofenadine HCl in plasma of rabbits. The optimized formulation containing Capryol 90 as absorption enhancer has a mean particle size 202.6 ± 3.9 nm and zeta potential −31.6 ± 0.9 mV. It achieved high entrapment efficiency of the drug 73.7 ± 1.7% and rapid Q3h release reaches 71.5 ± 2.7%. The design-optimized HPLC assay method in rabbit plasma could separate Fexofenadine HCl from endogenous plasma compounds in less than 3.7 min. The pharmacokinetic study and the pharmacological effect of the fexofenadine-loaded optimized formulation showed a significant increase in blood concentration and significantly higher activity against compound 48/80 induced systemic anaphylaxis-like reactions in mice. Therefore, enhanced in situ forming vesicles were effective nanocarriers for the entrapment and delivery of Fexofenadine HCl.
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Naveed, Safila. "EFFECT OF ACIDIC AND ALKALINE MEDIUM ON FEXOFENADINE BRANDS USING UV SPECTROPHOTOMETER." Canadian Journal of Applied Sciences 5 (2015): 1. http://dx.doi.org/10.21065/19257430.1.5.

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Fexofenadine is widely used drug for allergic conditions especially Rhiniti and is a selective histamine H1 receptor antagonist. In our recent research we study the effect of acidic and alkaline medium on four different brands of Fexofenadine, for this the solutions of different brands of Fexofenadine were subjected to neutral,alkaline and acidic medium. When Fexofenadine brands subjected to 0.1 N HCl and 0.1N NaOH for 30 minutes, Fexofenadine brands showed variable availability results.
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Ellis, Anne K., Margarita Murrieta-Aguttes, Sandy Furey, Pascaline Picard, and Christopher Carlsten. "Effect of fexofenadine hydrochloride on allergic rhinitis aggravated by air pollutants." ERJ Open Research 7, no. 2 (2021): 00806–2020. http://dx.doi.org/10.1183/23120541.00806-2020.

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In recent decades, seasonal allergic rhinitis (SAR) prevalence has increased and recent studies have shown that air pollutants, such as diesel exhaust particles (DEP), can increase inflammatory and allergic biomarkers. The aim of this study was to investigate the effects of DEP on SAR symptoms induced by ragweed and to evaluate the efficacy and safety of fexofenadine HCl 180 mg versus placebo.This phase 3, single-centre, sequential, parallel-group, double-blind, randomised study (NCT03664882) was conducted in an environmental exposure unit (EEU) during sequential exposures: Period 1 (ragweed pollen alone), Period 2 (ragweed pollen+DEP), and Period 3 (ragweed pollen+DEP+single-dose fexofenadine HCl 180 mg or placebo). Efficacy and safety were evaluated in Period 3. Primary endpoints were the area under the curve (AUC) of total nasal symptom score (TNSS) from baseline to hour 12 (AUC0–12) during Period 1 and Period 2; and the AUC of the TNSS from hour 2 to 12 (AUC2–12) during Period 3.251 out of 257 evaluable subjects were included in the modified intent-to-treat population. Least squares mean difference (95% CI) for TNSS Log AUC0−12 in Period 2 versus Period 1 was 0.13 (0.081–0.182; p&lt;0.0001). Least squares mean difference in TNSS Log AUC2−12 for fexofenadine HCl versus placebo during Period 3 was −0.24 (−0.425–−0.047; p=0.0148). One fexofenadine HCl-related adverse event was observed.SAR symptoms evoked by ragweed were aggravated by DEP. Fexofenadine HCl 180 mg was effective in relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms.
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Arefin, Paroma, Md Shehan Habib, Mohammad Mostafa, et al. "Fexofenadine HCl Microspheres – Can it be the First Line therapy for Allergic Disorders ?" Biosciences Biotechnology Research Asia 18, no. 4 (2021): 795–99. http://dx.doi.org/10.13005/bbra/2961.

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Fexofenadine HCl is a second-generation antihistamine which is commonly used for allergic disorders. But it has low bioavailability. Intranasal corticosteroids (INCs) and Immunotherapy and Allergen Specific Immunotherapy (ASIT) are now commonly being suggested for the treatment of allergic disorders. Despite the fact that current treatment alternatives have been in use for decades, patient quality of life has remained static. The treatment options are not much explored for their respective adverse effects. Therefore, they are in desperate need of research. Fexofenadine HCl is available in the form of a suspension, tablet, or capsule. In our current study, we have explored whether microspheres can be the perfect dosage form of Fexofenadine HCl to treat allergic disorders considering the pharmacokinetics of the drug, available dosage forms options and the probable side effects of the current therapies.
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Mason, J., R. Reynolds, and N. Rao. "The systemic safety of fexofenadine HCl." Clinical & Experimental Allergy 29 (July 1999): 163–70. http://dx.doi.org/10.1046/j.1365-2222.1999.0290s3163.x.

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K., Ramanji Reddy* Dr.Chandaka Madhu Dr. Mohammed Omar Sachin Vanji Ahirrao P.Jhansi Lakshmi. "FORMULATION AND EVALUATION OF MOUTH DISSOLVING TABLETS OF FEXOFENADINE HYDROCHLORIDE." Indo American Journal of Pharmaceutical Sciences 04, no. 09 (2017): 3230–42. https://doi.org/10.5281/zenodo.967492.

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In the present work, mouth dissolving tablets of fexofenadine HCl were designed with a view to enhance patient compliance by direct compression method. The present work studied the effect of superdisintegrants on release rate of fexofenadine HCl in the form of fast disintegrating tablet. For the present study range of superdisintegrants in their different concentrations, were used. The superdisintegrants used were Magnesium stearate, Microcrystalline Cellulose, Cross Povidone, Sodium Starch Glycolate,and Cross Carmellose Sodium. The blends were prepared by direct compression technique. The tablets were evaluated for hardness, thickness, friability, drug content, weight variation and in-vitro drug release studies in pH 6.8. Keywords: Fexofenadine hydrochloride, Mouth Dissolving Tablets, Magnesium Stearate, Microcrystalline Cellulose, Cross Povidone, Sodium Starch Glycolate,and Cross Carmellose Sodium
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22

Swati, Prasad, Chandra Shradha, and Babu Helena. "Bilastine with Montelukast and Fexofenadine with Montelukast in Allergic Rhinitis: A Randomized Control Trial." International Journal of Pharmaceutical and Clinical Research 16, no. 6 (2024): 2282–89. https://doi.org/10.5281/zenodo.13120255.

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<strong>Introduction:</strong>&nbsp;Allergic rhinitis is a global disease. It is an inflammatory disease affecting the mucosa of nasal cavity caused by exposure to an allergen which triggers IgE- mediated inflammation. There are four major symptoms of Allergic Rhinitis which includes &ndash; sneezing, rhinorrhea, nasal itching, and nasal congestion. The mainstay of management of allergic rhinitis is avoidance of allergens. Other treatments include intranasal corticosteroids, short term nasal decongestants, oral or topical H1 receptor antagonists (antihistamines), anticholinergic agents, intranasal cromoglycate, and allergen immunotherapy.&nbsp;<strong>Materials</strong>&nbsp;<strong>and</strong>&nbsp;<strong>Methodology:</strong>&nbsp;The present study has been performed to compare the efficacy of fexofenadine with montelukast versus Bilastine with montelukast in the patients with Allergic Rhinitis of either gender between the age of 18&ndash;60 years at a tertiary care teaching institution from November 1, 2022, to October 31, 2023.&nbsp;<strong>Observation and Results:</strong>&nbsp;In our investigation, we found the disease to be more common in younger 21-30 age group and middle-income category. In total nasal symptom score, sneezing has the highest score of 2.25 &plusmn; 0.5, followed by runny nose with 2.0 &plusmn; 0.8 and difficulty in sleeping had the least score of 1.2 &plusmn; 0.8.&nbsp;<strong>Conclusion:</strong>&nbsp;Allergic rhinitis is one of the most common immunologic and chronic disease experienced by humans. In our investigation, we found the disease to be more common in younger 21-30 age group and middle-income category. Majority of the subjects suffered from seasonal allergic rhinitis. Oral Bilastine with Montelukast were significantly superior when compared to Oral Fexofenadine with Montelukast. Bilastine with Montelukast was found to be more efficacious and provided more symptoms free duration. &nbsp; &nbsp; &nbsp;
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Ahmed, Shahriar, Mehrina Nazmi, Ikramul Hasan, Sabiha Sultana, Shimul Haldar, and Md Selim Reza. "Fexofenadine HCl Immediate Release Tablets: In vitro Characterization and Evaluation of Excipients." Bangladesh Pharmaceutical Journal 16, no. 1 (2013): 1–9. http://dx.doi.org/10.3329/bpj.v16i1.14483.

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Fexofenadine HCl immediate release tablets were designed to increase the dissolution rate by using superdisintegrants. Different formulations of Fexofenadine HCl were prepared by direct compression method. These formulations were evaluated for hardness, thickness, friability, weight variation, disintegration time, and in vitro dissolution study. The drug release from the formulations were studied according to USP specification (USP paddle method at 50 rpm for 60 minutes) maintaining the temperature to 37°C. Sodium starch glycolate, cross carmellose sodium, crospovidone (kollidon CL), ludiflash and xanthan gum were used in 3%, 6% and 8% concentrations as superdisintegrants. Thus, the ratio of superdisintegrants was changed whereas all the other excipients as well as the active drug (Fexofenadine HCl) remained same in every formulation. Here, 0.001N HCl was used as dissolution medium according to USP and absorbances were determined by using UV spectrophotometer at 217 nm. The F-3 and F-6 formulation prepared by 8% of Sodium starch glycolate and 8% of Cross carmellose sodium showed 99.99% drug release within 30 minutes and 45 minutes, respectively. The disintegration times of F-3 and F-6 formulation were within 9 seconds. The interactions between drug and excipients were characterized by FTIR spectroscopic study. DOI: http://dx.doi.org/10.3329/bpj.v16i1.14483 Bangladesh Pharmaceutical Journal 16(1): 1-9, 2013
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Meeves, Suzanne G., and Sireesh Appajosyula. "Efficacy and safety profile of fexofenadine HCL." Journal of Allergy and Clinical Immunology 112, no. 4 (2003): S69—S77. http://dx.doi.org/10.1016/s0091-6749(03)01879-7.

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Barge, Kajal, Shivali Tank, Bhagyashri Parab, Mangal Nagarsenkar, and Supriya Shidhaye. "Fexofenadine Hydrochloride Dispersible Tablets: A Taste Masking Strategy using Ion Exchange Resin." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 13, no. 03 (2023): 846–53. http://dx.doi.org/10.25258/ijddt.13.3.12.

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The pediatric population is more sensitive to allergies. Fexofenadine hydrochloride (FXD-HCL), a non-sedative antihistaminic drug, was chosen to create taste-masked patient-compliant pediatric dispersible tablets. Due to its bitter taste, fexofenadine hydrochloride is unsuitable for the formulation of dispersible tablets; therefore, Kyron T-134®, cation exchange resin was used to form a taste-masked complex with the drug to overcome its bitterness. The FXD HCL-resin complex was prepared using a kneading method and the complexation was confirmed by differential scanning calorimetry and FTIR studies. The FXD HCL-resin complex was evaluated for flow properties, degree of bitterness, assay and release study. Dispersible tablets were formulated by using a co-processed excipient, Granfiller-D211® containing croscarmellose sodium and crosspovidone, microcrystalline cellulose and mannitol. 22 factorial designs with two replicates optimized the dispersible tablets. The tablets, prepared using the direct compression technique on a single-stroke tablet compression machine, were elegant in appearance. Various pre and post-compression tests were conducted on all formulations. The tablets of hardness 3.5 kg/cm2 showed friability, disintegration time, assay within the compendial limit and showed immediate release of a drug (NLT 60% in 10 min and NLT 80% in 30 minutes) in 0.001 N HCl (pH 3). The DSC thermogram indicated partial amorphization of the FXD HCL. Dispersible tablets of fexofenadine hydrochloride and Granfiller-D®211 at 1:4 proportion was stable for one month at ambient and accelerated storage conditions.
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Kaur, Gurpreet, Rachna Dhingra, Manjinder Singh, and Manpreet Kaur. "Montelukast: a better alternative than antihistaminics in allergic rhinitis." International Journal of Otorhinolaryngology and Head and Neck Surgery 3, no. 2 (2017): 317. http://dx.doi.org/10.18203/issn.2454-5929.ijohns20171185.

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&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;Allergic rhinitis is associated with sleep disturbances, daytime somnolence, and fatigue. Hence, present study was undertaken to evaluate and compare the nocturnal symptoms such difficulty in going to sleep, night time awakening and nasal congestion/obstruction on awakening among allergic rhinitis patients after administration of montelukast, chlorpheniramine meleate, levocetrizine, desloratidine and fexofenadine and to find out anti-allergic drug with maximum improvement in total symptom complex score. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;The present study comprised of 125 patients suffering from allergic rhinitis on the basis of characteristic history, corroborative physical findings and blood eosinophilia. Night times symptoms including difficulty in going to sleep, night time awakenings and nasal congestion on awakening were evaluated after patients were given oral treatment with chlorpheniramine maleate, levocetrizine, fexofenadine, desloratadine and montelukast for a period of 6 weeks in different 5 groups and the result interpreted on the basis of symptoms relieved. Symptoms were recorded on day 1, 2 weeks, 4 weeks and 6 weeks of treatment and analysed. All the patients were randomly divided into five groups of 25 each. The results were tabulated and analyzed by chi-square, Kruskal-Wallis test. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;The present study found that levocetirizine provided immediate effect at 2 weeks which is significantly better than other drugs. But at 6 weeks, montelukast is best among the drugs which were compared; followed by levocetrizine, fexofenadine, and desloratadine and chlorpheniramine maleate. Montelukast was found to be a better drug as it has no significant side effects. Desloratadine group had dryness of mouth. Chlorpheniramine maleate has maximum side effects. 6 patients who took chlorpheniramine maleate complained of sedation, 1 patient complain of psychomotor disturbance. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;The present study concludes that in terms of clinical efficacy, safety/tolerability and improvement in night time symptom scores at six weeks therapy in allergic rhinitis, montelukast is the better drug.&lt;/span&gt;&lt;/p&gt;
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da Costa, Lucas Maciel, Heitor Oliveira de Almeida Leite, Nájla Mohamad Kassab, and Anil Kumar Singh. "Green Analytical Methods for the Separation of Seven Antihistamines: Application in Separation of Azelastine and Related Impurities in Nasal Solution." International Journal of Analytical Chemistry 2019 (February 11, 2019): 1–11. http://dx.doi.org/10.1155/2019/9489723.

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Antihistamines are widely used to alleviate the symptoms caused by allergic reactions. Most of these drugs have zwitteriónicas and/or amphoteric characteristics, which confer additional analytical challenges. This work aimed to develop a single eco-friendly and efficient chromatographic methods for analysis of seven antihistamines, namely, azelastine HCl, desloratadine, ebastine, fexofenadine HCl, ketotifen, loratadine, and olopatadine HCl. The separations were obtained using RP C-18 LUNA (150x4.6mm, 5 μm) column. The mobile phase consisted of acetonitrile and acidified water (pH 2.1) in the following proportion: 15:85, v/v for desloratadine, 25:75, v/v for ketotifen and olopatadine, 32:68, v/v for fexofenadine, 35:65, v/v for azelastine and loratadine, and 45:55, v/v for ebastine. All separations were obtained in less than 7.0 min. A prototype method was fully validated and applied in the assay of azelastine HCl in nasal solutions. The proposed methods for analysis of seven antihistamines are highly efficient, selective, and sensitive. Moreover, all methods can be considered excellent in terms of greenness, with total organic residue &lt; 2.5 mL/analysis. An improved gradient method is also described for separation of azelastine HCl and its related impurities.
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BRANNAN, JOHN D, SANDRA D ANDERSON, KERRY GOMES, GREGORY G KING, H. KIM CHAN, and J. PAUL SEALE. "Fexofenadine Decreases Sensitivity to and Montelukast Improves Recovery from Inhaled Mannitol." American Journal of Respiratory and Critical Care Medicine 163, no. 6 (2001): 1420–25. http://dx.doi.org/10.1164/ajrccm.163.6.2006019.

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Arefin, Paroma, Md Shehan Habib, Mohammad Mostafa, et al. "Evaluation of the Influence of Stirring Speed on the Release Kinetics of Fexofenadine HCl Polymeric Microspheres." Biosciences Biotechnology Research Asia 18, no. 4 (2021): 733–41. http://dx.doi.org/10.13005/bbra/2955.

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Microspheres, a potential drug delivery approach, has opened a new era for attaining versatile release patterns needed. By optimizing the formulation variables, they can be prepared to obtain targeted release, immediate release, sustained release patterns. The release of the active drug material depends upon a number of formulation parameters such as polymers, stirring speed (rpm), methodology, surfactants, etc. Fexofenadine hydrochloride (HCl) is a second generation antihistamine. Our present research has explored the effects of using different rpm (600- 1000 rpm) in preparing fexofenadine hydrochloride (HCl) microspheres by emulsion solvent evaporation method. The formulation is aimed to provide sustained release for the required long period with a high margin of safety. We used a blended mixture of Hydroxy Propyl Methyl Cellulose (HPMC) K 100 MCR and Eudragit RL100 polymers to have sustained-release microspheres. The impact of different rpm on Yield, drug encapsulation efficiency, flow properties, and dissolution pattern were appraised. We observed the release of the drug for 10 hours in phosphate buffer (pH 6.8) and evaluated the drug release spectrophotometrically. Our study finds that the release of fexofenadine HCl from the microspheres was significantly increased with drug loading. We found the dosage forms to follow Higuchi release kinetics and Hixson-Crowell release kinetics the most, indicating successful achievement of sustained-release pattern in the dosage form. The change in drug release rate was statistically significant for variation in the stirring rate. We found that 600 rpm was the most optimized stirring rate for preparing microspheres in the emulsion solvent evaporation method.
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Nagendrakumar, D., SA Raju, SB Shirsand, MS Para, and MV Rampure. "Fast dissolving tablets of fexofenadine HCl by effervescent method." Indian Journal of Pharmaceutical Sciences 71, no. 2 (2009): 116. http://dx.doi.org/10.4103/0250-474x.54272.

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31

Pankhaniya, Mona, Parula Patel, and JS Shah. "Stability-indicating HPLC method for simultaneous determination of montelukast and fexofenadine hydrochloride." Indian Journal of Pharmaceutical Sciences 75, no. 3 (2013): 284. http://dx.doi.org/10.4103/0250-474x.117426.

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32

Ahn, Jung Hwan, Junhyeong Kim, Naveed Ur Rehman, Hye-Jin Kim, Mi-Jeong Ahn, and Hye Jin Chung. "Effect of Rumex Acetosa Extract, a Herbal Drug, on the Absorption of Fexofenadine." Pharmaceutics 12, no. 6 (2020): 547. http://dx.doi.org/10.3390/pharmaceutics12060547.

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Herbal drugs are widely used for the auxiliary treatment of diseases. The pharmacokinetics of a drug may be altered when it is coadministered with herbal drugs that can affect drug absorption. The effects of herbal drugs on absorption must be evaluated. In this study, we investigated the effects of Rumex acetosa (R. acetosa) extract on fexofenadine absorption. Fexofenadine was selected as a model drug that is a substrate of P-glycoprotein (P-gp) and organic anion transporting polypeptide 1A2 (OATP1A2). Emodine—the major component of R. acetosa extract—showed P-gp inhibition in vitro and in vivo. Uptake of fexofenadine via OATP1A2 was inhibited by R. acetosa extract in OATP1A2 transfected cells. A pharmacokinetic study showed that the area under the plasma concentration–time curve (AUC) of fexofenadine was smaller in the R. acetosa extract coadministered group than in the control group. R. acetosa extract also decreased aqueous solubility of fexofenadine HCl. The results of this study suggest that R. acetosa extract could inhibit the absorption of certain drugs via intervention in the aqueous solubility and the drug transporters. Therefore, R. acetosa extract may cause drug interactions when coadministered with substrates of drug transporters and poorly water-soluble drugs, although further clinical studies are needed.
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33

Sanam, Sherejad, Sharmin Nahar, Nazmus Saqueeb, and SM Abdur Rahman. "A Validated RP-HPLC Method and Force Degradation Studies of Fexofenadine Hydrochloride in Pharmaceutical Dosage Form." Dhaka University Journal of Pharmaceutical Sciences 17, no. 1 (2018): 43–50. http://dx.doi.org/10.3329/dujps.v17i1.37118.

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A stability indicating HPLC method was developed and validated for the quantitative determination of fexofenadine hydrochloride. An isocratic separation was achieved using phenomenex (C18) column (250×4.6 mm, 5 μm) with flow rate of 1.0 ml/min and UV detection at 254 nm. The mobile phase consists of 5Mm acetate buffer: acetonitrile (50:50; v/v) with pH 9.4 adjusted with acetic acid. The drug was subjected to oxidative, acidic, basic, neutral, photolytic and thermal degradation. All degradation products were eluted in an overall analytical run time of approximately 40 min with the parent compound fexofenadine hydrochloride at a flow rate of approximately 3.3±0.3 min. The method was linear over the concentration range of 31.5-500 μg/ml (r2 = 0.999) with limit of detection and quantification of 3.5 μg/ml and 10.1 μg/ml, respectively. The method has the requisite accuracy, selective, precision and robustness to assay fexofenadine HCl in tablets.Dhaka Univ. J. Pharm. Sci. 17(1): 43-50, 2018 (June)
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Golcu, Ayşegul, Burcu Dogan, and Sibel A. Ozkan. "Anodic Voltammetric Behavior and Determination of Antihistaminic Agent: Fexofenadine HCl." Analytical Letters 38, no. 12 (2005): 1913–31. http://dx.doi.org/10.1080/00032710500230871.

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35

Simons, F. Estelle R., Lana Johnston, Xiaochen Gu, and Keith J. Simons. "Suppression of the early and late cutaneous allergic responses using fexofenadine and montelukast." Annals of Allergy, Asthma & Immunology 86, no. 1 (2001): 44–50. http://dx.doi.org/10.1016/s1081-1206(10)62354-x.

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36

Arefin, Paroma, Ikramul Hasan, Md Shfiqul Islam, and Md Selim Reza. "Formulation and In vitro Evaluation of Eudragit RL 100 Loaded Fexofenadine HCl Microspheres." Bangladesh Pharmaceutical Journal 19, no. 1 (2016): 58–67. http://dx.doi.org/10.3329/bpj.v19i1.29240.

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The present study deals with the formulation and evaluation of Fexofenadine hydrochloride (HCl) loaded sustained release microspheres by emulsion solvent evaporation method with Eudragit RL 100. The effects of percent drug loading on drug encapsulation efficiency, drug content and drug release rate were assessed. In vitro dissolution study was performed spectrophotometrically according to USP paddle method using phosphate buffer (pH 6.8) for 10 hours. The release rate of Fexofenadine HCl from the microspheres was significantly increased with the increase of drug loading. The drug release patterns were simulated in different kinetic orders such as zero order release kinetics, first order release kinetics, Higuchi release kinetics, Korsmeyer-Peppas release kinetics and Hixson-Crowell release kinetics to assess the release mechanism and Higuchi release kinetics was found to be the predominant release mechanism. Morphological changes due to different drug loading were assessed by scanning electron microscopic (SEM) technique. Differential scanning calorimetry and fourier transform infra-red (FT-IR) spectroscopy was performed to evaluate compatibility of drug with the polymer. A statistically significant variation indrug encapsulation efficiency and release rate was observed for variation in drug loading.Bangladesh Pharmaceutical Journal 19(1): 58-67, 2016
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37

Sonia K, Devipriya A, Yamini P, and Sam Ezhil Kumar S. "Eco-Friendly and UV Spectrophotometric HPLC Methods for Multivariate Calibration Based Montelukast Sodium and Fexofenadine Estimation." International Research Journal of Multidisciplinary Scope 06, no. 02 (2025): 1401–16. https://doi.org/10.47857/irjms.2025.v06i02.03256.

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A new green Reverse Phased-HPLC technique have been developed for the analysis of Montelukast sodium in both bulk and pharmaceutical formulations, using ethanol and sodium dihydrogen orthophosphate buffer as mobile phase in an 80:20 v/v ratio. The above method was developed and validated in accordance with ICH guidelines for linearity and range, sensitivity, recovery, precision, detection limit, quantification limit, and robustness. The results were found to be within the acceptance limits in accordance with ICH guidelines. This eco-friendly method reduces the usage of harmful organic solvents, making it a sustainable alternative in pharmaceutical analysis. Furthermore, by using the multilinear regression technique, for the assessment of Fexofenadine and Montelukast in their bulk pharmaceutical formulation, a novel, precise, and progressive spectrophotometric technique was created. The method was validated using various validation parameters and were found to be within the limits specified. This makes the method suitable for routine quality control analysis. It also demonstrates strong potential for application in stability studies and pharmacokinetic evaluations. Future research may focus on extending this green approach to other antihistaminic and anti-asthmatic drug combinations. This advancement highlights the growing importance of green analytical chemistry in modern pharmaceutical development, promoting safer, cleaner, and more sustainable laboratory practices globally.
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Mahmood, Sajid, Zaheer Ahmad, and Muhammad Arshad. "Estimation of Fexofenadine HCl and Pseudoephedrine HCl by Spectrophotometer and TLC in Combined Tablet Dosage Form." Open Journal of Chemistry 1, no. 1 (2018): 1–11. http://dx.doi.org/10.30538/psrp-ojc2018.000.

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Mahmood, Sajid, Zaheer Ahmad, and Muhammad Arshad. "Estimation of Fexofenadine HCl and Pseudoephedrine HCl by Spectrophotometer and TLC in Combined Tablet Dosage Form." Open Journal of Chemistry 1, no. 1 (2018): 1–11. http://dx.doi.org/10.30538/psrp-ojc2018.0001.

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40

Abd El-Hay, Soad S., Magda Y. El-Mammli, and Abdalla A. Shalaby. "Spectrophotometric Determination of Desloratadine, Fexofenadine HCL, Etodolac, Moexipril HCL and Thiocolchicoside in Pure and Pharmaceutical Formulations." Biosciences Biotechnology Research Asia 8, no. 1 (2011): 49–58. http://dx.doi.org/10.13005/bbra/822.

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41

Vena, G. A., N. Cassano, M. Filieri, R. Filotico, V. D'Argento, and C. Coviello. "Fexofenadine in Chronic Idiopathic Urticaria: A Clinical and Immunohistochemical Evaluation." International Journal of Immunopathology and Pharmacology 15, no. 3 (2002): 217–24. http://dx.doi.org/10.1177/039463200201500308.

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Fexofenadine is a non-sedating selective third-generation antihistamine, which also exerts an anti-inflammatory action. The aim of this study was to evaluate the influence on the expression of inflammatory skin mediators, together with the efficacy and tolerability, of fexofenadine in chronic idiopathic urticaria (CIU). Fexofenadine 180mg was administered once daily for 4 weeks after a placebo run-in phase of 3 to 7 days. Efficacy paramaters were obtained from patients' assessment of urticaria symptoms. Non-lesional skin of patients with active CIU was studied immunohistochemically before and after treatment. The expression of the following mediators was evaluated: adhesion molecules (ICAM-1, ELAM-1, VCAM-1); mast cell proteases (chymase and tryptase) and proinflammatory cytokines (IL-1β, IL-3, IL-6 and TNF-α). Of the 20 subjects enrolled, 3 dropped out of the study. Treatment proved successful in most cases (88.2%) (p &lt;0.01) and a significant improvement of all symptoms was registered. Treatment was well-tolerated by all patients; adverse events, neither serious nor drug-related, occurred in any case. Immunochemistry revealed at the baseline a significant expression of ELAM-1, VCAM-1, tryptase, chymase, and TNF-α (p &lt;0.05) in non-lesional skin of patients compared to normal controls. After treatment with fexofenadine, there was a significant decrease in the expression of ELAM-1 (p= 0.02), VCAM-1 (p= 0.04) and tryptase (p=0.04), whereas no relevant change was observed for the other parameters examined. This work confirms the efficacy and tolerability of fexofenadine HCl 180mg in CIU. These preliminary data show a trend towards a decrease in the expression of tryptase and some adhesion molecules after treatment, suggesting an anti-inflammatory activity of fexofenadine.
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42

Kumar, P. Rajeev, and Rekha Rajeev Kumar. "Q analysis of Montelukast sodium and Fexofenadine hydrochloride in Tablet Formulation by Derivative Spectrophotometry." Asian Journal of Research in Chemistry 10, no. 2 (2017): 174. http://dx.doi.org/10.5958/0974-4150.2017.00029.3.

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43

Shintani, Takako, Chika Ohata, Hiroshi Koga, et al. "Combination therapy of fexofenadine and montelukast is effective in prurigo nodularis and pemphigoid nodularis." Dermatologic Therapy 27, no. 3 (2013): 135–39. http://dx.doi.org/10.1111/dth.12094.

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44

TINKELMAN, D., C. FALLIERS, E. BRONSKY, H. KAISER, and J. MASON. "1009 Efficacy and safety of fexofenadine HCl in fall seasonal allergic rhinitis." Journal of Allergy and Clinical Immunology 97, no. 1 (1996): 435. http://dx.doi.org/10.1016/s0091-6749(96)81227-9.

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Nelson, Harold S., Robert Reynolds, and Jolene Mason. "Fexofenadine HCl is safe and effective for treatment of chronic idiopathic urticaria." Annals of Allergy, Asthma & Immunology 84, no. 5 (2000): 517–22. http://dx.doi.org/10.1016/s1081-1206(10)62515-x.

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46

Aldeeb, Reem, Mohamed Kassem, Ahmed Atef, and Hanan Refai. "Formulation and pharmacokinetic evaluation of a single tablet formula containing montelukast sodium and fexofenadine hydrochloride." Journal of Pharmaceutical Sciences and Drug Manufacturing 1, no. 1 (2024): 40–53. http://dx.doi.org/10.21608/jpsdm.2024.258514.1011.

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47

Abd El-Hay, Soad S., Christa L. Colyer, Wafaa S. Hassan, and Abdalla Shalaby. "Spectrofluorimetric Determination of Etodolac, Moxepril HCl and Fexofenadine HCl Using Europium Sensitized Fluorescence in Bulk and Pharmaceutical Preparations." Journal of Fluorescence 22, no. 1 (2011): 247–52. http://dx.doi.org/10.1007/s10895-011-0954-8.

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48

Mahatme, MohiniSachin, GaneshNatthuji Dakhale, Kanchan Tadke, SachinKeshaorao Hiware, SD Dudhgaonkar, and Sumit Wankhede. "Comparison of efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine in patients of allergic rhinitis: A randomized, double-blind clinical trial." Indian Journal of Pharmacology 48, no. 6 (2016): 649. http://dx.doi.org/10.4103/0253-7613.194854.

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49

Kawashima, Makoto, and Shotaro Harada. "Efficacy and Safety of Fexofenadine HCl in Japanese Patients with Chronic Idiopathic Urticaria." International Archives of Allergy and Immunology 124, no. 1-3 (2001): 343–45. http://dx.doi.org/10.1159/000053752.

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50

Monroe, E. W., G. Gross, S. Meeves, Y. Liao, S. T. Varghese, and G. Georges. "Once-daily fexofenadine HCl 180 mg is effective for the treatment of CIU." Journal of Allergy and Clinical Immunology 115, no. 2 (2005): S106. http://dx.doi.org/10.1016/j.jaci.2004.12.439.

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