Estudio de bioequivalencia de los fármacos más relevantes incluidos en el cuadro nacional de medicamentos básicos del Ecuador

Abstract

The bioequivalence of generic drugs comprises a series of studies that determine their interchangeability with innovative drugs. Multisource drug molecules must be analyzed for their biopharmaceutical quality, as well as their bioavailability; however, there is a way to demonstrate their bioequivalence through in vitro assays, due to their high solubility and permeability characteristics. The National Table of Basic Medicines (CNMB) of Ecuador in its latest version of 2022, includes a compendium of essential medicines that every public institution must offer for the accessibility of medicines to the population, and which is based on aspects such as the epidemiological picture from the country. The objective of this work is to determine the bioequivalence of the most relevant drugs included in the CNMB of Ecuador, through a bibliographic review of manuscripts published in the country, as well as its comparison with international studies, in this way, nine drugs were investigated the dissolution profile tests and the values obtained for the difference factor (f1), as well as for the similarity factor (f2) were analyzed. The results obtained were that, if there are bioequivalence studies in Ecuador, including metformin, amoxicillin, ibuprofen, paracetamol and enalapril, in addition to this, amlodipine, clonazepam, diclofenac and acetylsalicylic acid, studies were found in Latin American countries, where five of them complied with bioequivalence. In conclusion, most generic drugs have pharmaceutical interchangeability and the importance of bioequivalence studies is transcendental to achieve reliability in terms of their pharmaceutical and therapeutic equivalence.