Abstract

PHARMACEUTICAL EVALUATION OF DIFFERENT TABLET BRANDS OF LETROZOLE AND IMATINIB MESYLATE MARKETED IN LIBYA

Abubakr O. Nur*, Abdallah M. A. Saad, Latifa B. Babiker, Zuheir A. Osman

Abstract

Objectives: This study addresses pharmaceutical evaluation of different batches within two brands of two anticancer drugs, Letrozole and Imatinib mesylate tablets, that are available in Libyan drug market. Methods: Different tablet batches were subjected to in vitro evaluation for their weight variation, drug content, uniformity of dosage unit, disintegration and drug dissolution attributes. Determined quality parameters for tablet batches were then compared to their official standards stated in compendial Pharmacopoeia. Results: Inspite of the significant variations (p< 0.05) observed in quality parameters among tested tablet batches, all evaluated batches of Letrozole and Imatinib mesylate were found within the official specifications for weight, drug content, uniformity of dosage unit and disintegration. Dissolution studies indicated that all tested tablet batches have complied with official specifications for drug dissolution (> 80% at 30 minutes). However, in relation to Biopharmaceutical Classification System, which is a newly introduced concept and applied in regions of International Conference on Harmonization (ICH), one batch each of Letrozole and Imatinib mesylate failed the criteria for rapidly dissolving tablets that considers > 85% of drug dissolution within 30 minutes. The study concluded that batches within the evaluated brands of Letrozole and Imatinib mesylate tablets could be regarded as being biopharmaceutically and chemically equivalent and, therefore, can be interchanged in the clinical practice.

Keywords: Letrozole tablets; Imatinib mesylate tablets; Pharmaceutical evaluation; quality control parameters; Libyan drug market.