DISEÑO DE PROCESOS DE PRODUCCIÓN DE TABLETAS CON INGREDIENTES ACTIVOS BIOLÓGICOS.

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Bibliographic Details
Title:	DISEÑO DE PROCESOS DE PRODUCCIÓN DE TABLETAS CON INGREDIENTES ACTIVOS BIOLÓGICOS.
Alternate Title:	MANUFACTURE PROCESSES DESIGN FOR TABLETS WITH BIOLOGICAL ACTIVE INGREDIENTS.
Authors:	García Suárez, José¹ jgarcia@oc.medsol.cu, Gutiérrez García, Aurora Margarita¹, Míguez Suárez, Alidagmi¹, Jiménez Gómez, Isabel¹, Rodríguez Piñero, Olga Lidia¹, Zumalacárregui de Cárdenas, Lourdes²
Source:	Revista CENIC Ciencias Biologicas. 2025, Vol. 56, p34-44. 11p.
Subjects:	TABLETING, ORAL drug administration, PHARMACEUTICAL chemicals manufacturing, QUALITY assurance, DRUG stability, TREATMENT effectiveness, BIOACTIVE compounds, INTESTINAL barrier function
Abstract (English):	The biological active ingredients have gradually become more attractive therapeutic molecules than small molecular drugs due to their high selectivity and efficacy, but fewer side effects. Owing to the poor stability and limited permeability through gastrointestinal (GI) tract and epithelia, the therapeutic biologicals are usually administered by parenteral route. Given the big demand for oral administration in clinical use, a variety of researches focused on developing new technologies to overcome GI barriers of biologicals, such as enteric coating, enzyme inhibitors, permeation enhancers, nanoparticles, as well as intestinal microdevices. One of the current trends in the pharmaceutical industry is the manufacture of more patient-friendly medications. The tablets are non-invasive formulations that are easy to handle in consumption since they can be supplied at home. However, biomolecules have specific characteristics that make them different from chemical ingredients. The objective of this work is to highlight the aspects that must be taken into account to develop this type of production from the laboratory to its commercialization. The industrial drug manufacturing process is undergoing a significant transformation; the quality systems traditionally used in the development and manufacturing of drugs have rapidly evolved towards development and manufacturing processes that use the principles of quality by design (QbD), whose philosophy It is quality planning, together with adequate risk management to achieve the desired quality profile and for the medicine to guarantee its therapeutic efficacy. [ABSTRACT FROM AUTHOR]
Abstract (Spanish):	Los ingredientes activos biológicos se han convertido gradualmente en las moléculas terapéuticas más atractivas que los fármacos de pequeña masa molar a causa de su alta selectividad, eficacia y menos efectos secundarios. Debido a la escasa estabilidad y la permeabilidad limitada a través del tracto gastrointestinal (TGI) y los epitelios, las moléculas biológicas terapéuticas suelen administrarse por vía parenteral. Dada la gran demanda de administración oral en uso clínico, unas variedades de investigaciones se centraron en el desarrollo de nuevas tecnologías con el fin de superar las barreras gastrointestinales para estas macromoléculas, entre otras, el recubrimiento entérico, inhibidores de enzimas, potenciadores de la permeación, nanopartículas y microdispositivos intestinales. Una de las tendencias actuales en la industria farmacéutica es la fabricación de medicamentos más amigables para el paciente. Las tabletas son formulaciones no invasivas y de fácil manejo en el consumo. Sin embargo, las biomoléculas tienen características específicas que las diferencian de los ingredientes químicos. El objetivo de este trabajo es resaltar los aspectos que se deben tener en cuenta para desarrollar este tipo de producción desde el laboratorio hasta su comercialización. El proceso de fabricación industrial de medicamentos está sufriendo una importante transformación, los sistemas de calidad utilizados tradicionalmente en el desarrollo y fabricación de fármacos han evolucionado rápidamente hacia procesos de desarrollo y fabricación que utilizan los principios de la calidad por diseño (QbD), cuya filosofía es la planificación de la calidad, unido a una adecuada gestión de riesgos para alcanzar el perfil de calidad deseado y que el medicamento garantice su eficacia terapéutica. [ABSTRACT FROM AUTHOR]
	Copyright of Revista CENIC Ciencias Biologicas is the property of Centro Nacional de Investigaciones Cientificas and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database:	MedicLatina

Description
Abstract:	The biological active ingredients have gradually become more attractive therapeutic molecules than small molecular drugs due to their high selectivity and efficacy, but fewer side effects. Owing to the poor stability and limited permeability through gastrointestinal (GI) tract and epithelia, the therapeutic biologicals are usually administered by parenteral route. Given the big demand for oral administration in clinical use, a variety of researches focused on developing new technologies to overcome GI barriers of biologicals, such as enteric coating, enzyme inhibitors, permeation enhancers, nanoparticles, as well as intestinal microdevices. One of the current trends in the pharmaceutical industry is the manufacture of more patient-friendly medications. The tablets are non-invasive formulations that are easy to handle in consumption since they can be supplied at home. However, biomolecules have specific characteristics that make them different from chemical ingredients. The objective of this work is to highlight the aspects that must be taken into account to develop this type of production from the laboratory to its commercialization. The industrial drug manufacturing process is undergoing a significant transformation; the quality systems traditionally used in the development and manufacturing of drugs have rapidly evolved towards development and manufacturing processes that use the principles of quality by design (QbD), whose philosophy It is quality planning, together with adequate risk management to achieve the desired quality profile and for the medicine to guarantee its therapeutic efficacy. [ABSTRACT FROM AUTHOR]
ISSN:	02535688