Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina

Abstract

Dissolution studies have evolved from a simple quality control test to an indicator of biopharmaceutical performance and alternative for in vivo equivalence and interchangeability assessment. Pharmaceutical equivalents imply products formulated with the same active pharmaceutical ingredient (API), in the same quantity and dosage form, that are intended to be administered by the same route fulfill the same quality criteria. The medicine market in Argentina is composed mostly of multisource products that are supposed to be pharmaceutical equivalents, but the generic market here is different from other parts of the world. In this scenario, the comparison of different products formulated with the same API becomes essential. Allopurinol, the drug of choice in the treatment of gout and tumor lysis syndrome, is classified as an essential medicine according to the World Health Organization. The present work aimed to compare critical quality attributes and in vitro dissolution characteristics of Allopurinol tablets purchased in Argentina to establish pharmaceutical equivalence. All evaluated products fulfilled the pharmaceutical equivalence criteria. Three of the tested products (the reference and two multisource formulations) comply with the criteria for ‘very rapidly dissolving’ and can be described as similar.