Evaluation of the physicochemical equivalence of three brands of commercially available quinine sulphate tablets from South Western part of Nigeria
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria
Background: The relatively little resistance to quinine globally has led to an increase in its use in P. falciparum malaria especially in multi-drug resistant strains. Objective: To evaluate the physicochemical and equivalency of three brands of quinine sulphate tablets available in South Western region of Nigeria. Methods: The pharmaceutical and chemical equivalence of three brands of quinine sulphate tablets were assessed through the evaluation of some biopharmaceutical parameters and active drug content. Results: All the brands complied with the official specification for uniformity of weight. Two of the brands (A & B) gave similar crushing strengths while the third brand (C) gave a much lower value. Similarly all the brands complied with the official specification of disintegration test but the obtained values were statistically different (p<0.05). The T70 obtained from the dissolution rate profile was less than 45 minutes for the three brands, although A and B were not statistically different but C was statistically from A and B. The quinine content of brands B and C are within the official specification however brand A with percentage content of 110±1.3%w/w, is above the specification while it is statistically different from the other brands. Conclusion: Brands B and C could be regarded as chemical equivalent, but they are not biopharmaceutical equivalents, on the other hand, brands A and B may be regarded as biopharmaceutical equivalents but not chemical equivalent.
quinine sulfate; article; biopharmaceutical equivalence; chemical equivalence; controlled study; crushing strength; drug determination; drug dosage form comparison; drug purity; drug solubility; Nigeria; pharmacological parameters; physical chemistry; tablet disintegration; Antimalarials; Chromatography, Thin Layer; Drugs, Generic; Humans; Malaria, Falciparum; Quality Control; Quinine; Solubility; Tablets; Therapeutic Equivalency