THE EVALUATION OF SOME BRANDS OF LEVOCETIRIZINE DIHYDROCHLORIDE FILM-COATED TABLETS FOR QUALITY AND EQUIVALENCE SOLD IN ADEN, YEMEN
Keywords:Levocetirizine dihydrochloride, Quality, Equivalence, Differential factor, Similarity factor
Generic drugs are less expensive than innovator drugs, and their proliferation has become a problem in low-income countries. They need to be therapeutically and pharmaceutically equivalent to the innovator. Levocetirizine dihydrochloride is an effective drug for relieving the signs of chronic urticaria, perennial allergic rhinitis, and seasonal allergic rhinitis. Our investigation into this drug in private pharmacies in Aden, Yemen, revealed that it is sold under the names of 28 brands from different countries of origin. Because of this, it is difficult for medical professionals and patients who use this medication without a prescription to select a suitable, safe, and cost-effective drug product. We assessed the quality and equivalency of six different brands of levocetirizine dihydrochloride film-coated tablets and assigned codes A, B, C, D, E, and F, with Brand A serving as the reference. The UV analytical method was evaluated for quantifying the drug from the tablets. The results indicated that it was accurate and precise. The tablets were evaluated for weight variation, thickness, hardness, friability, drug content, disintegration time, and dissolution. In order to compare the drug's dissolving profiles, the difference factor (f1) and similarity factor (f2) were used. For all six brands, the physicochemical parameter results met the acceptable limits. All six brands showed evidence of dissolving within 15 minutes, with values ranging from 80.05 ±0.81 to 103.83 ±0.90 which were within the recommended value of 80% within 30 minutes for oral solid dosage forms intended for immediate release. According to the f1 and f2 results, only brands B, D, and E were comparable to brand A and could be used interchangeably. In conclusion, four of the six brands are interchangeable. For high-quality public health, a thorough analysis and ongoing monitoring are needed to ascertain the quality and equivalency of the medications marketed under various brands.