ES2721325T3 - Método para producir de manera estéril partículas de lípido-ácido nucleico - Google Patents

Método para producir de manera estéril partículas de lípido-ácido nucleico Download PDF

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ES2721325T3
ES2721325T3 ES12829180T ES12829180T ES2721325T3 ES 2721325 T3 ES2721325 T3 ES 2721325T3 ES 12829180 T ES12829180 T ES 12829180T ES 12829180 T ES12829180 T ES 12829180T ES 2721325 T3 ES2721325 T3 ES 2721325T3
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unit
solution
lipid
organic solvent
organic
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Victor Knopov
Richard Witte
Priya Karmali
Robin Lee
David Webb
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Nitto Denko Corp
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Abstract

Método para preparar de manera estéril una nanopartícla de lípido-ácido nucleico en condiciones asépticas, que comprende el uso de un sistema que comprende componentes de un solo uso, que comprende: una 1.ª unidad de contención para una disolución lipídica orgánica que comprende lípidos en un disolvente orgánico miscible con agua; una 2.ª unidad de contención para una disolución acuosa que comprende un fármaco terapéutico; una unidad de mezclado con una mezcladora estática; un medio de inyección para añadir la disolución lipídica orgánica desde la 1.ª unidad de contención hasta la cámara de mezclado de un modo para formar un gradiente de la concentración de disolvente orgánico de la disolución en la unidad de mezclado de manera que el aumento es gradual desde un valor de inyección inicial hasta un valor de inyección final; una 3.ª unidad de contención para un tampón acuoso; una unidad de dilución; una unidad de concentración que comprende un filtro de transflujo para concentrar la suspensión de liposomas y eliminar el disolvente orgánico; y un lecho de un solo uso para recoger la suspensión de liposomas concentrada tras la eliminación del disolvente orgánico; y en el que todos los componentes del sistema, que están en contacto con lípidos, fármacos, disolventes y tampones se esterilizan y pueden desecharse de modo que están adaptados para su uso en un único lote; en el que el método se lleva a cabo de manera que el disolvente orgánico miscible con agua es etanol; la unidad de mezclado contiene la disolución acuosa de fármaco, y la disolución lipídica se añade constantemente a la disolución de fármaco en la unidad de mezclado formando de ese modo dicho gradiente de manera que el suministro de la disolución orgánica se completa en de 1 minuto a 100 minutos, de manera que se alcanza una razón de ARN:lípido de 0,06 a 0,16 (p:p) y de manera que se alcanza una concentración de etanol final del 25-45 %; y en el que la mezcla de lípido-fármaco se transfiere a la unidad de dilución y se diluye mediante la adición del tampón acuoso.
ES12829180T 2011-11-04 2012-11-02 Método para producir de manera estéril partículas de lípido-ácido nucleico Active ES2721325T3 (es)

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US201161556124P 2011-11-04 2011-11-04
PCT/IB2012/002916 WO2013064911A2 (en) 2011-11-04 2012-11-02 Single use system for sterilely producing lipid-nucleic acid particles

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US (1) US8956572B2 (es)
EP (4) EP2773326B1 (es)
JP (3) JP6133883B2 (es)
KR (2) KR102056702B1 (es)
CN (2) CN103906503B (es)
AU (2) AU2012356239B2 (es)
CA (2) CA2853685C (es)
CY (1) CY1121495T1 (es)
DK (1) DK2773326T3 (es)
ES (1) ES2721325T3 (es)
HR (1) HRP20190481T1 (es)
HU (1) HUE043809T2 (es)
LT (1) LT2773326T (es)
PL (1) PL2773326T3 (es)
PT (1) PT2773326T (es)
RS (1) RS58562B1 (es)
RU (2) RU2642640C2 (es)
SI (1) SI2773326T1 (es)
SM (1) SMT201900197T1 (es)
TR (1) TR201904389T4 (es)
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WO (2) WO2013093648A2 (es)

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