Innovación en el Tratamiento de la DMAE - Port Delivery System con Implante de Ranibizumab
Arturo Alezzandrini, Pablo Chamartin, María Victoria Cibrán
Keywords :
Port Delivery System (PDS), implante ocular permanente, perfiles farmacocinéticos (PK), inyecciones intravítreas
Citation Information :
Alezzandrini A, Chamartin P, Cibrán MV. Innovación en el Tratamiento de la DMAE - Port Delivery System con Implante de Ranibizumab. 2022; 15 (4):4-11.
El Port Delivery System (PDS) con Ranibizumab consiste en un implante ocular permanente que permite la administración de fármacos en el humor vítreo. Está diseñado para liberar de forma continua una formulación personalizada de Ranibizumab 100 mg/ml en el vítreo por difusión pasiva a través de un elemento de control de liberación de titanio poroso. Las tasas de liberación de Ranibizumab a través del implante utilizado en los estudios del PDS en pacientes con degeneración macular asociada a la edad neovascular se seleccionaron basándose en los datos clínicos y farmacocinéticos (PK, por sus siglas en inglés) de los estudios de inyección intravítrea de Ranibizumab realizados anteriormente.
Para determinar la liberación del fármaco desde el implante, se midió la tasa de liberación in vitro con concentraciones iniciales de Ranibizumab de 10, 40 y 100 mg/ml, y se comprobó que la liberación de Ranibizumab de 40 y 100 mg/mL seguía siendo cuantificable después de 6 meses. Utilizando una concentración inicial de 100 mg/mL, la tasa de liberación activa a los 6 meses aproximadamente fue consistente tras el llenado inicial y el primer, segundo y tercer recambio, demostrando la reproducibilidad entre implantes y entre múltiples recambios del mismo implante. Se demostró que un recambio de medicación realizado con 100 mL utilizando la aguja de recambio diseñada para el implante sustituía más del 95% del contenido del implante con fármaco fresco. Los datos in vitro apoyan el uso del PDS con intervalos fijos de recambio de al menos 6 meses en los ensayos clínicos.
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