Formulation and pharmacopoeial quality evaluation of ketorolac tromethamine IR tablet and comparison with marketed product

Abstract

This study describes the formulation of immediate release Ketorolac tromethamine (KT) 10-mg tablet by direct compression method; evaluation of their compliance to various Pharmacopoeial quality parameters, i.e., weight variation, friability, hardness, thickness, moisture content, disintegration, assay, and dissolution; and their comparison with marketed brands for determination of pharmaceutical equivalency. Five formulations of KT were prepared (coded as FKT1, FKT2, FKT3, FKT4, and FKT5) by direct compression method using different superdisintegrants. Micrometric properties of the mixtures of the drug and the excipients prepared for formulation were evaluated. Quality evaluation of the five different formulations and randomly selected four different brands of KT 10-mg tablets purchased from the local market (coded as LKT1, MKT2, MKT3, and SKT4) were performed according to Pharmacopoeia. The results were obtained by UV-Vis spectrophotometer and all the dissolution profiles were characterized by the zeroorder kinetics. All the brands of KT and developed formulations met the official specification except SKT4 which showed excessive moisture content of 7.18%. None of the tested brands of KT were found to be pharmaceutically equivalent, whereas two developed formulation were pharmaceutically equivalent with the in house benchmark (MKT2) from which their interchangeability can be suggested.