Estudio comparativo de las características físico-químicas y biofarmacéuticas de diferentes marcas comerciales de cápsulas de omeprazol 40 mg

Abstract

Introduction: Quality control of capsules is vital to ensure the medicines’ quality, safety, and effectiveness. Quality testing is essential to meet standards, detect potential problems, and build trust in patients and healthcare professionals. Objective: To conduct a comparative study of the physical-chemical and biopharmaceutical characteristics of innovative and generic omeprazole 40 mg capsules, comparing them with United States Pharmacopeia (USP) values through a statistical analysis. Methodology: The methodology applied was experimental and descriptive, analyzing the quality of five different brands of 40 mg Omeprazole capsules sold in Cuenca-Ecuador. The type of sample was for convenience. Results: The dough uniformity, friability, and disintegration tests showed average values in the five brands evaluated. In the stability test, there was an alteration within the physicochemical parameters presented; however, it can be caused by several factors, including poor storage in the pharmacy or even poor manufacturing. Nonetheless, it is worth clarifying that the leading cause can vary, and it is not necessarily related to poor manufacturing, considering that the medication was not sampled as soon as it left the factory but was obtained directly from different pharmacies. Conclusion: The study indicates that certain brands obtained from different pharmacies in Cuenca do not comply with the established parameters regarding physicochemical, biopharmaceutical, and stability characteristics.