Nanoemulsions are particularly suitable as a platform in the development of delivery systems. The type of nanoemulsion with a higher stability will offer an advantage in the preparation of a delivery system for lipophilic drugs. Nanoemulsions can be fabricated by different processing methods, which are usually categorized as either high- or low-energy methods. In this study, a comparison between two methods of preparing magnetic oil-in-water (O/W) nanoemulsions is described. The nanoemulsions were formed by sonication (the high-energy method) or by spontaneous emulsification (the low-energy method). In both cases, the oil phase was olive oil, and a phospholipid and a pegylated phospholipid were used as emulsifiers. To favor the comparison, the amounts of the components were the same in both kinds of nanoemulsions. Moreover, nanoemulsions were loaded with hydrophobic superparamagnetic nanoparticles and indomethacin. In vitro, releases studies indicated a short drug burst period followed by a prolonged phase of dissolutive drug release. The Korsmeyer-Peppas model can fit the associated kinetics. The results showed that such nanoemulsions are suitable as a platform in the development of delivering systems for lipophilic drugs. The long-term stability was also examined at different temperatures, as well as the interaction with plasma proteins. Nanoemulsion obtained by the low-energy method showed a great stability at 4 °C and at ambient temperature. Its size and polydispersity did not change over more than two months. The spontaneous emulsification method therefore has great potential for forming nanoemulsion-based delivery systems.
In the Americas, The United States of America, Canada, Mexico, and Brazil are the top vaccine producers and the countries with the leading infrastructure for biological manufacturing. The North American countries have the most demanding legislation regulating and controlling these pharmaceuticals’ distribution and production. Some Latin American countries rank in the top 20 of worldwide vaccine manufacturers, with Cuba, Brazil, México and Colombia have a self-sufficient vaccine production of 72.7%, 54,2%; 25%; and 7.7%, respectively, of the national vaccine demand. On the other hand, the rest of Latin American countries cannot satisfy their demand for vaccines, and most of their efforts are associated with the distribution within their health systems rather than in transferring technology.Based on this literature review, the results suggest an increasing growth vaccine demand, not only for their growing populations and previously established demand but also for the recently exerted pressure due to the COVID-19 pandemic.Because the American continent has a marked inequality between the hegemonic producers of vaccines, the exporters, and those that depend heavily on importing these products, this could assert technological dependence in countries with rapid population growth and jeopardize the effectiveness of the two vaccination plans.
Antecedentes: Helicobacter pylori es una bacteria Gram negativa, reconocida como la causa de la úlcera péptica (UP) y cáncer el gástrico (CG). Se han identificado genes de virulencia asociados con la patogenicidad del H. pylori incluyendo la isla de patogenicidad cagA y la citotoxina vacuolizante A (vacA). La frecuencia de los genes de patogenicidad se ha asociado con la localización geográfica y condiciones de vida de las personas. Pocos estudios en el Ecuador, han demostrado la relación entre los genes de patogenicidad de H. pylori y regiones geográficas de diferente altitud. Este estudio analizó los genes de patogenicidad de biopsias gástricas dos parroquias del Ecuador: una ubicada en la altura, Zumbahua (Sierra Central) y otra a nivel del mar, Shushufindi (Amazonía). Métodos: Se obtuvieron 127 muestras de biopsias gástricas embebidas en parafina de sujetos provenientes de Zumbahua (n = 90) y Shushufindi (n = 37). Mediante un análisis histopatológico se determinó la presencia de la infección y alteraciones patológicas tisulares. Se seleccionaron las muestras de los pacientes con mayor índice de infección por H. pylori (++ y +++ en el examen histopatológico) para el análisis molecular del H. pylori; se aisló su ADN y se evaluaron los genes de patogenicidad por PCR. Resultados: Se determinó la presencia de 5 casos de cáncer gástrico en la parroquia de Zumbahua, con mayor frecuencia en hombres que en mujeres. En la parroquia de Sushufindi hubo mayor prevalencia de infección por H. pylori comparada con Zumbahua. El análisis molecular de los genes de patogenicidad determinó que hubo una mayor expresión de estos en las muestras provenientes de la parroquia de Zumbahua; el 20% de las muestras amplificaron para vacAm1, 8.57% para vacAs1 y el 20% para vacAs2; mientras que para Shushufindi, únicamente el 8.0% amplificó para el gen vacAm1.Conclusiones: La prevalencia de infección por H. pylori en las muestras de las parroquias estudiadas es alta. Los genes de patogenicidad asociados con mayor virulencia provinieron de Zumbahua así como también las muestras con cáncer. Por otro lado, en las muestras de Shushufindi los genes de patogenicidad fueron menos virulentos y no hubo casos de malignidad. Es necesario establecer sistemas de tamizaje tanto para detectar cepas de H. pylori con genes de virulencia como para la detección temprana del cáncer gástrico.
The number of approved biological medicines in the global pharmaceutical market has increased in recent decades. However, their high costs have also promoted the development of biosimilar medicines, following the expiry of the patent of the reference drug. Biosimilars are approved medicines of biological origin which have no statistically significant differences in terms of quality, safety and therapeutic efficacy in comparison with the reference biological. Drugs marketed as biomimics meanwhile are copies of monoclonal antibodies and fusion proteins that have not demonstrated bioequivalence to their reference biologicals. Across the world, regulations have been developed to ensure the safety and efficacy of biosimilar products, which can reduce public health expenditure and improve patient access to biological medicines. As a result, Latin America has begun to invest in the development of these drugs. The objective of this literature review is to describe the development of the biosimilar and biomimic market in Latin America.
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