In Vitro Pharmaceutical Quality Evaluation of Loratadine Tablets in Saudi Arabia

Introduction: Loratadine (LOR) is a widely used second-generation antihistamine that blocks histamine H1 receptors and relieves allergic symptoms.A variety of LOR brands are marketed in Saudi Arabia.The objective of this study was to compare the dissolution characteristics of various generic brands of LOR tablets with the innovator product available in Saudi Arabia.Methods: The dissolution study was conducted with four generic LOR products (LOR2, LOR3, LOR4, and LOR5) and the innovator product (LOR1) using the United States Pharmacopeia (USP) paddle apparatus in two different dissolution media, i.e., 0.1-N hydrochloric acid (HCl) and acetate buffer (pH 4.5).Samples were collected at specified time intervals and analyzed for in vitro drug release using ultraviolet (UV) spectrophotometry.Results: After 60 minutes in 0.1-N HCl, LOR1 (Ref), LOR2, LOR3, LOR4, and LOR5 presented cumulative mean SD drug release of 91.91% 1.67%, 90.88% 3.64%, 92.26% 2.77%, 96.08% 2.27%, and 94.15% 1.55%.In acetate buffer (pH 4.5), the cumulative drug release was 87.94% 5.05%,78.52% 4.04%, 105.35% 1.83%, 87.71% 2.53%, and 88.47% 2.07% for LOR1, LOR2, LOR3, LOR4, and LOR5 respectively after 1 h.The drug content of all studied tablet products was within the acceptable range.Conclusion: Rapid dissolution of LOR tablets was observed for all products in 0.1-N HCL; however, in acetate buffer (pH 4.5), one generic product (LOR2) exhibited a slightly lower release rate of LOR than the innovator product.This study highlights the importance of a comprehensive evaluation of generic products available in local market when considering the interchangeability between innovator and generic products.