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Optimización del proceso en la extrusión en caliente farmacéutica: detección de volátiles en tiempo real mediante
Aaron D Smith1, Ecaterina Bordos1, Michael Devlin1
1CMAC, University of Strathclyde, Technology and Innovation Centre, Glasgow, United Kingdom; Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.
International journal of pharmaceutics
|January 27, 2026
Resumen
La espectrometría de masas de flujo de iones seleccionados (SIFT-MS) define con precisión las ventanas de procesamiento de polímeros farmacéuticos para la extrusión en caliente (HME). Este método detecta cambios químicos tempranos, lo que permite la fabricación optimizada de dispersiones sólidas amorfas.
Área de la Ciencia:
- Ciencia Farmacéutica
- Química de Polímeros
- Ingeniería de Procesos
Sus antecedentes:
- La extrusión en caliente (HME) es crucial para la fabricación de dispersiones sólidas amorfas (ASD).
- Establecer ventanas de procesamiento robustas para polímeros farmacéuticos durante HME es un desafío debido a las limitaciones del análisis térmico convencional.
- Los cambios químicos tempranos en los polímeros durante HME a menudo no son detectados por los métodos estándar.
Objetivo del estudio:
- Utilizar la espectrometría de masas de flujo de iones seleccionados (SIFT-MS) para la caracterización en tiempo real de la evolución de volátiles durante el procesamiento de polímeros.
- Establecer métodos basados en datos para definir el inicio de cambios químicos significativos en polímeros farmacéuticos.
- Determinar ventanas de procesamiento específicas para polímeros para HME para mejorar la fabricación de ASD.
Principales métodos:
- Se empleó espectrometría de masas de flujo de iones seleccionados (SIFT-MS) acoplada a análisis de componentes principales (PCA).
- Se monitorizó la evolución de volátiles en tiempo real bajo condiciones de análisis termogravimétrico (TGA) y HME.
- Se utilizaron mapas de distancia de centroides y cargas de PCA para identificar transiciones térmicas y cambios químicos distintos.
Principales resultados:
- SIFT-MS y PCA identificaron con éxito transiciones distintas que indican el inicio de la evolución química impulsada por la temperatura en cuatro polímeros: Soluplus®, Affinisol™15LV, Kollidon® VA64 y Plasdone™ S630 Ultra.
- Se definieron ventanas de procesamiento específicas: Soluplus® y Plasdone™ S630 Ultra (150-170°C), Kollidon® VA64 (160-180°C) y Affinisol™15LV (170-185°C).
- Estos límites definidos químicamente, respaldados por datos reológicos, fueron más estrechos y precisos que los rangos proporcionados por el fabricante.
Conclusiones:
- SIFT-MS ofrece un método rápido y no destructivo para detectar cambios químicos sutiles y tempranos en polímeros durante HME, mucho antes que el análisis térmico convencional.
- Esta técnica permite la definición precisa de ventanas de extrusión específicas para polímeros, mejorando la comprensión y optimización del proceso para ASD.
- Los hallazgos facilitan una fabricación más robusta y eficiente de dispersiones sólidas amorfas.
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