Diseño de mezcla aplicado al desarrollo de formulaciones farmacéuticas: Una visión integral
DOI:
https://doi.org/10.29076/issn.2528-7737vol19iss52.2026pp37-53pPalavras-chave:
Diseño de mezcla, Diseño D-óptimo, Formulaciones farmacéuticas, Quality by Design, Simplex-LatticeResumo
El diseño de mezclas (MD) representa una herramienta estadística eficaz para optimizar formulaciones donde los componentes deben sumar una proporción constante. En el desarrollo farmacéutico, las proporciones relativas de principios activos y excipientes determinan directamente la estabilidad, solubilidad, biodisponibilidad y calidad del producto final. El objetivo de esta revisión fue proporcionar una visión general del diseño de mezcla y su aplicación en el desarrollo y optimización de formas farmacéuticas. Se realizó una revisión narrativa de la literatura en las bases de datos: PubMed, Scopus, Google Scholar, en el periodo 2020-2026. Se analizaron 49 artículos originales y revisiones sistemáticas, metaanálisis que abordaran la aplicación del MD en formulación farmacéutica. El diseño D-óptimo fue el más utilizado (55,1%, n=27), seguido del Simplex-Lattice (32,7%, n=16). Las aplicaciones se concentraron en sistemas autoemulsificantes y nanoemulsiones (38,8%), geles e hidrogeles (22,4%) y formas sólidas orales (22,4%). El software Design-Expert predominó (78% de los estudios que reportaron herramienta computacional). Se concluye que el diseño de mezclas constituye una herramienta metodológica versátil y eficiente para el desarrollo racional de formas farmacéuticas, con aplicabilidad transversal en múltiples sistemas de entrega y vías de administración, y con proyección creciente en el marco del Quality by Design
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