Cetirizine tablet
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Cetirizine Tablets: Efficacy, Quality, and Formulation Insights
Efficacy of Cetirizine in Treating Allergic Rhinitis
Cetirizine, a second-generation antihistamine, is widely used to treat symptoms of seasonal allergic rhinitis, such as runny nose, sneezing, and itchy eyes. A randomized controlled trial compared the efficacy of cetirizine with butterbur, another treatment for hay fever. The study found that both treatments were similarly effective in improving symptoms, as measured by the SF-36 questionnaire and clinical global impression scale. However, cetirizine was associated with sedative effects like drowsiness and fatigue in some patients, despite being classified as a non-sedating antihistamine1.
Quality Assessment of Cetirizine Tablets
A study evaluating five brands of cetirizine hydrochloride tablets marketed in Abuja, Nigeria, assessed various quality parameters such as weight variation, friability, hardness, disintegration, and dissolution. The results showed that all brands conformed to quality standards, with disintegration times within 5 minutes and dissolution rates ranging from 80.0% to 103.3% within 30 minutes. The assay results ranged from 93.1% to 101.6%, indicating that the tablets met the required specifications2.
Fast Disintegrating Tablets (FDT) of Cetirizine
Fast disintegrating tablets (FDT) are gaining popularity due to their convenience, especially for pediatric and geriatric patients who have difficulty swallowing conventional tablets. Research on cetirizine dihydrochloride FDTs has shown that the type and amount of lubricants used, as well as the compression force during manufacturing, significantly affect the tablet's disintegration time, hardness, and dissolution profile. Sodium stearyl fumarate was found to be a more effective lubricant than magnesium stearate, resulting in higher drug release rates3. Another study successfully developed taste-masked oral disintegrating tablets of cetirizine HCl, which disintegrated rapidly and were well-received in sensory evaluations6.
Anti-Inflammatory Effects of Cetirizine
Cetirizine has been shown to reduce inflammatory cell recruitment and ICAM-1 (CD54) expression on conjunctival epithelium in both early- and late-phase reactions after allergen-specific conjunctival challenge. This indicates that cetirizine not only alleviates symptoms but also has a protective effect on cellular inflammatory responses4.
Bioavailability and Comparative Studies
A comparative study on the bioavailability of two cetirizine dihydrochloride tablet formulations (Zetir and Zyrtek) in healthy male volunteers found no significant differences between the two brands. Both formulations were deemed bioequivalent based on parameters such as AUC, Cmax, Tmax, and elimination half-life5. Another study in Karachi, Pakistan, evaluated various brands of cetirizine hydrochloride tablets and found differences in pharmaceutical parameters like thickness, hardness, and disintegration, which could affect bioavailability8.
Adverse Reactions and Safety
While cetirizine is generally well-tolerated, there have been reports of adverse reactions. For instance, a case study documented a 40-year-old woman who developed acute generalized exanthematous pustulosis (AGEP) after taking cetirizine. Patch testing confirmed the reaction was due to cetirizine, highlighting the importance of monitoring for potential adverse effects7.
Conclusion
Cetirizine tablets are effective in treating allergic rhinitis and other allergy symptoms, with various formulations available to enhance patient convenience and compliance. Quality assessments ensure that marketed brands meet required standards, while research into fast disintegrating tablets offers promising alternatives for those with swallowing difficulties. Despite its efficacy, cetirizine can cause sedative effects and, in rare cases, severe allergic reactions, underscoring the need for careful patient monitoring.
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Most relevant research papers on this topic
Randomised controlled trial of butterbur and cetirizine for treating seasonal allergic rhinitis
Butterbur is an effective and well-tolerated treatment for seasonal allergic rhinitis, especially when sedating effects are a concern.
RCT
Highly CitedEvaluation of some quality parameters of five brands of Cetirizine hydrochloride tablets marketed in Abuja, Nigeria.
Cetirizine hydrochloride 10mg tablets marketed in Abuja, Nigeria, meet quality standards for hardness, friability, disintegration, and dissolution.
Spatial distributing lubricants from Raman mapping and scanning electron microscopy–energy dispersive X-ray spectroscopy on cetirizine dihydrochloride fast disintegrating tablet properties
Sodium stearyl fumarate as lubricant in fast disintegrating tablets has higher drug release than magnesium stearate, with less impact on hardness and disintegration time.
Cetirizine reduces inflammatory cell recruitment and ICAM-1 (or CD54) expression on conjunctival epithelium in both early- and late-phase reactions after allergen-specific challenge.
Cetirizine effectively reduces inflammatory cell recruitment and ICAM-1/CD54 expression in both early- and late-phase reactions after allergen-specific conjunctival challenge.
RCTHighly CitedComparative bioavailability of single doses of tablet formulations of cetirizine dihydrochloride in healthy male volunteers.
Both Zetir and Zyrtek tablet formulations of cetirizine dihydrochloride show bioequivalent bioavailability in healthy male volunteers.
RCTDevelopment and Evaluation of Cetirizine HCl Taste-Masked Oral Disintegrating Tablets
Cetirizine HCl taste-masked oral disintegrating tablets effectively mask the bitter active and improve tablet palatability.
In Vitro StudyHighly CitedCetirizine induced acute generalized exanthematous pustulosis confirmed by patch testing
Cetirizine can cause acute generalized exanthematous pustulosis, with strong positive reactions observed in atopic patients.
Case ReportA Comparative Study of Different Brands of Cetirizine Hydrochloride Tablets Available in Karachi, Pakistan
Different brands of cetirizine hydrochloride tablets in Karachi, Pakistan, show variations in pharmaceutical parameters, which can impact their bioavailability and effectiveness as anti-histaminic drugs.
Development and validation of a dissolution test for a once-a-day combination tablet of immediate-release cetirizine dihydrochloride and extended-release pseudoephedrine hydrochloride.
The developed dissolution test for a once-a-day combination tablet containing immediate-release cetirizine dihydrochloride and extended-release pseudoephedrine hydrochloride is robust, discriminating, and transferable, with a pH range of 1.1-7.5 and independent of apparatus, pH,
Formulation Development and Evaluation of Fast Disintegrating Tablet of Cetirizine Hydrochloride: A Novel Drug Delivery for Pediatrics and Geriatrics
Fast disintegrating tablets of Cetirizine Hydrochloride successfully provide rapid onset of action, enhance patient convenience, and compliance for allergic and respiratory disorders.
In Vitro Study