Comparative Study of Metronidazole Tablets Marketed in Saudi Arabia

Introduction: Metronidazole is usually used as an oral antiprotozoal and antibacterial agent to treat skin and mouth infections, bacterial vaginosis, and pelvic inflammatory diseases as well as some sexually transmitted infections (trichomoniasis and giardiasis.Methods: This study compared three generic brands of 250-mg metronidazole tablets (Amrizole, Riazole, Anazol) available in Saudi Arabia with the reference brand (Flagyl) according to United States Pharmacopeial (USP) specifications, including in vitro dissolution and physicochemical characteristics (i.e., uniformity of drug content, weight, hardness, thickness, and diameter, friability, and disintegration).In addition, anti-blastocyte activity was studied to evaluate the biological activity of the formulated nanocomposites by using cultured Blastocystis sp.suspension from symptomatic patients.Blastocystis sp. was subcultured with fresh Jones medium enriched with 10% horse serum to remove stool debris.Results: All products met USP specifications for all physical and physicochemical parameters, including the drug content assay (i.e., all products contained 94-99% of the label claim).The dissolution profiles showed no differences between the products.The biological activity showed the metronidazole started to destroy Blastocystis sp.within 1 hour, and all cells were dead by the end of 24 hours.Conclusion: All tested brands were bioequivalent under biowaiver conditions, with no significant differences in physical and physicochemical parameters as well as biologic activity against blastocystosis.The generic metronidazole tablets can be used interchangeably with the brand name product.