In vitro Bioequivalence of Peruvian Formulations of Ketorolac Tromethamine

Abstract

Introduction: In developing countries, drug accessibility is a public health problem that requires effective, safe and lower cost therapeutic alternatives to comply with their pharmacological treatment.

Objective: To evaluate the in vitro bioequivalence of Peruvian formulations of ketorolac tromethamine.

Methods: We worked with ketorolac tromethamine tablets from two laboratories authorized by the regulatory entity and compared them with an innovative drug. The working conditions were based on the specifications established in the pharmacopoeia in force, which considered water as dissolution medium, volume 600 mL, type II apparatus, 50 rpm, time 45 min and temperature 37 ± 0.5ºC. The dissolved percentages according to sampling time were obtained from the preparation of the calibration curve and, subsequently, the dissolution efficiency (ED%) and the similarity factor (f2) were calculated.

Results: Formulation B reached 85% of drug dissolved at 10 min, the dissolution efficiency was similar to the innovator drug and was excluded from the f2 calculation, since it is a very fast dissolving drug. In formulation C, the data obtained did not meet the specifications determined by international organizations for bioequivalence studies.

Conclusions: Formulation B is interchangeable with the innovator drug, and for this reason, it represents a therapeutic alternative to solve health problems.