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Estudios de Compatibilidad de Mezclas en Formulaciones Parenterales: Perspectivas de Empaquetado, Dispositivos y
Chetana Eknure1, Vishvesh Joshi2, Yogeshwar Bachhav3
1Adex Pharma, Tilak Nagar, Mumbai, Maharashtra, 400089, India.
AAPS PharmSciTech
|January 9, 2026
Resumen
Las terapias parenterales se enfrentan a riesgos por incompatibilidades de fármacos e interacciones con dispositivos. Los estudios de compatibilidad de mezclas son cruciales para garantizar la seguridad y eficacia de estos tratamientos vitales.
Área de la Ciencia:
- Farmacología; Ciencia de Materiales; Farmacia Clínica
Sus antecedentes:
- Las terapias parenterales son esenciales en cuidados críticos, oncología y nutrición.
- Las preocupaciones de seguridad surgen de las incompatibilidades de mezclas y las interacciones fármaco-dispositivo.
- Estos problemas afectan la estabilidad del fármaco, la eficacia y los resultados del paciente.
Objetivo del estudio:
- Revisar las incompatibilidades fisicoquímicas y basadas en materiales en las formulaciones parenterales.
- Destacar riesgos como la precipitación, los cambios de pH y los lixiviables.
- Examinar las interacciones con los sistemas de empaquetado y los requisitos reglamentarios.
Principales métodos:
- Síntesis de la literatura sobre la comprensión científica actual.
- Examen crítico de las interacciones con componentes de vidrio, plásticos, elastómeros y silicona.
- Revisión de las normas reglamentarias para extractables, lixiviables y la integridad del sistema contenedor-cierre.
Principales resultados:
- Las incompatibilidades pueden provocar precipitación, cambios de pH, separación de fases y adsorción.
- Los riesgos documentados incluyen el fracaso del tratamiento, reacciones de infusión y retiradas de productos.
- Las interacciones con los materiales de empaquetado plantean importantes desafíos de seguridad.
Conclusiones:
- Los estudios de compatibilidad de mezclas son esenciales para la administración segura de fármacos parenterales.
- Las estrategias emergentes, como el empaquetado avanzado y la monitorización, pueden mejorar la seguridad.
- Garantizar la compatibilidad es clave para la fiabilidad de las terapias parenterales.
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