Desarrollo y escalamiento productivo de un nuevo surfactante pulmonar

Este trabajo es una guía referencial para el desarrollo de nuevos productos biofarmacéuticos y se basa en la experiencia obtenida del desarrollo de un nuevo Surfactante Pulmonar. Mediante las estadísticas de nacimientos prematuros, se estimó que la demanda del producto en los países del ALBA es de 45.000 viales de 120 mg/vial por año para el año 2007. Para la extracción y purificación del nuevo surfactante, a partir pulmones de porcinos, se desarrolló un protocolo novedoso que es aplicable a nivel industrial. El medicamento consiste en una sustancia biológica liofilizada, clasificada como polvo estéril para reconstituir, formulado para resuspenderse en 3ml. de agua para inyectables, para su aplicación por vía endotraqueal. Los proveedores de la materia prima son mataderos industriales, certificados por la autoridad sanitaria (MPPS), y por la autoridad ambiental (MINAMB). Para garantizar que el sistema productivo mantenga los atributos de calidad del medicamento, desde la producción, pasando por su distribución en el mercado, hasta la utilización del surfactante en neonatos, se diseñó una infraestructura apropiada y calificada para la producción masiva. El proceso para la industrialización del medicamento se basa en la normativa sanitaria vigente, que exige el control de todas sus fases: concepción, diseño, construcción, equipamiento, adecuaciones, puesta en marcha y funcionamiento de la planta. Este control implica el establecimiento de un Sistema de Aseguramiento de la Calidad, con alcance a todos los ámbitos de la empresa fabril y su cadena de distribución, que garantice la ejecución continua y consistente de todos los procesos.&nbsp

Analytical Methods for the Determination of Major Drugs Used for the Treatment of COVID-19. A Review

At the beginning of the COVID-19 outbreak (end 2019 2020), therapeutic treatments based on approved drugs have been the fastest approaches to combat the new coronavirus pandemic. Nowadays several vaccines are available. However, the worldwide vaccination program is going to take a long time and its success will depend on the vaccine public’s acceptance. Therefore, outside of vaccination, the repurposing of existing antiviral, anti-inflammatory and other types of drugs, have been considered an alternative medical strategy for the COVI-19 infection. Due to the broad clinical potential of the drugs, but also to their possible side effects, analytical methods are needed to monitor the drug concentrations in biological fluids and pharmaceutical products. This review deals with analytical methods developed in the period 2015 - July 2021 to detect potential drugs that, according to a literature survey, have been taken into consideration for the treatment of COVID-19. The drugs considered here have been selected on the basis of the number of articles published in the period January 2020-July 2021, using the combination of the keywords: COVID-19 and drugs or SARS-CoV-2 and drugs. A section is also devoted to monoclonal antibodies. Over the period considered, the analytical methods have been employed in a variety of real samples, such as body fluids (plasma, blood and urine), pharmaceutical products, environmental matrices and foo

[Double outlet right ventricle. Angiographic study]

Cineangiographic study in 41 patients with double outlet right ventricle was performed. Segmental approach was utilized to describe the anatomical features. Atrial situs was inversus in 5 cases, ambiguous in 3 and solitus in the other cases. Atrio-ventricular (a-v) connections were biventricular in 34 and univentricular in 7. A common a-v valve was found in 2 cases. Mitral valve was imperforated in 1 and straddling in 1. The most frequent relationship between aorta and pulmonary artery was side by side (41.1%). Ventricular septal defect was subaortic in 14, subpulmonary in 9, double committed in 5 and non committed in 6. In 27 cases a double infundibulum was present; in 7 patients we described a subpulmonary conus only. Some nosological aspects of this congenital heart disease are discussed particularly in conformity with the surgical needs