ES2394111T3 - Apósitos para heridas con agentes antimicrobianos y que contienen cinc - Google Patents
Apósitos para heridas con agentes antimicrobianos y que contienen cinc Download PDFInfo
- Publication number
- ES2394111T3 ES2394111T3 ES07755143T ES07755143T ES2394111T3 ES 2394111 T3 ES2394111 T3 ES 2394111T3 ES 07755143 T ES07755143 T ES 07755143T ES 07755143 T ES07755143 T ES 07755143T ES 2394111 T3 ES2394111 T3 ES 2394111T3
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- Prior art keywords
- agent
- layer
- wound dressing
- zinc
- layers
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- MYPYJXKWCTUITO-LYRMYLQWSA-O vancomycin(1+) Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C([O-])=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)[NH2+]C)[C@H]1C[C@](C)([NH3+])[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-O 0.000 description 1
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Abstract
Un apósito para heridas que comprende una primera capa (30), una segunda capa (20) y una tercera capa (40),caracterizado porque cada una de la primera, segunda y tercera capas (30, 20, 40) contiene al menos un agenteantimicrobiano y al menos un agente que contiene cinc.
Description
Apósitos para heridas con agentes antimicrobianos y que contienen cinc.
ANTECEDENTES
En el debate del estado de la técnica que sigue, se hace referencia a algunas estructuras y/o métodos. Sin embargo, las siguientes referencias no deben tomarse como una admisión de que estas estructuras y/o métodos constituyen la técnica anterior. El solicitante se reserva expresamente el derecho a demostrar que dichas estructuras y/o métodos no se califican como técnica anterior.
Se ha sugerido una variedad de apósitos para heridas. Sin embargo, dichos apósitos para heridas poseen diversas deficiencias y carencias.
Por ejemplo, se han propuesto numerosos apósitos para heridas que incluyen diversos agentes antimicrobianos. Lógicamente, un aumento en la cantidad de agente antimicrobiano contenido en el apósito para heridas sugeriría un aumento en la eficacia en el combate y/o la prevención de la infección. Sin embargo, ciertos agentes antimicrobianos populares, tal como el gluconato de clorhexidina (GCH) puede tener un efecto irritante sobre la piel, especialmente cuando se aplican mayores niveles o concentraciones de GCH.
La solicitud de Patente de los Estados Unidos US 2004/082925 A1 da a conocer un apósito para heridas que comprende una primera capa interna, hidrófila, y una segunda y una tercera capas externas, hidrófobas. En el que la capa interna contiene polihexametileno bisguanida. No se menciona ningún agente que evite la irritación de la piel.
De esta manera, existe una necesidad en la técnica de apósitos para heridas que tengan una eficacia relativamente mayor en el combate y/o la prevención de la infección, pero que no posean desventajas, tales como una creciente irritación de la piel.
SUMARIO
De acuerdo con un aspecto opcional de la presente invención, se proporciona un control mejorado de la biocarga, sin recurrir a aumentar las concentraciones de los agentes antimicrobianos, tales como PHMB. De acuerdo con un aspecto opcional adicional de la presente invención, se proporciona el apósito para heridas que reduce el riesgo de infección, o facilita el control de una infección existente, sin cambio en el protocolo sanitario de la herida existente. De acuerdo con un aspecto aún más opcional de la presente invención, se proporciona un apósito para heridas que aumentará eficazmente el espectro de actividad del agente antimicrobiano contenido en el mismo. De acuerdo con otro aspecto opcional de la presente invención, se proporciona un apósito para heridas que proporciona una administración dirigida y/o controlada de un agente antimicrobiano y/o aditivos adicionales contenido en el apósito para heridas al sitio de la herida.
De acuerdo con otro aspecto adicional de la presente invención, se proporciona un apósito para heridas que comprende: una primera capa interna, y una segunda y tercera capas externas, en el que cada una de la primera, segunda y tercera capas contiene un agente antimicrobiano y un agente que contiene cinc.
Tal como se usa en la presente memoria descriptiva “que contiene” o “contiene” se toman ampliamente para significar que una o más capas por sí mismas y/o el(los) material(es) que las integran están impregnados con, y/o tienen revestimientos / tratamientos aplicados a una superficie de otro(s) material(es) / agente(s). La impregnación y/o los revestimientos / tratamientos superficiales se pueden aplicar a todas o a una parte de las capas o del(los) material(es) que forman las capas. Finalmente, el término abarca todos los métodos o técnicas de impregnación y/o revestimientos / tratamientos superficiales, con respecto al estado del (de los) material(es) / agente(s) que se aplican a los anteriores (por ejemplo, sólido, líquido, gas, plasma, etc.). El(los) material(es) / agente(s) añadidos se pueden aplicar durante la fabricación o posteriormente a ésta (por ejemplo, por el usuario / consumidor antes de la aplicación de la una o más capas al sitio de la herida).
BREVE DESCRIPCIÓN DE LOS DIBUJOS
La figura 1 es una ilustración esquemática de una realización a modo de ejemplo de un apósito para heridas
antimicrobiano de la presente invención.
La figura 2 es una ilustración esquemática de la sección transversal, tomada a lo largo de las líneas 2 – 2 de
la figuras 1 de realizaciones alternativas de un apósito para heridas antimicrobiano de la presente invención.
DESCRIPCIÓN DETALLADA
Se puede hacer referencia a las figuras 1 – 2 a fin de facilitar el siguiente debate. En los aspectos más amplios, la presente invención proporciona un apósito para heridas (10) que comprende tres o más capas que contienen cada una un primer agente antimicrobiano y al menos un agente que contiene cinc.
Un apósito para heridas formado de acuerdo con los principios de la presente invención puede formar generalmente tres o más capas discretas (por ejemplo, 20, 30, 40). Cada una de ellas o más capas se puede formar a partir de cualquier material y/o construcción adecuados. Por ejemplo, una o más capas pueden formarse a partir de un material fibroso, de tipo película, espuma y/o gel. Con respecto a los materiales fibrosos, pueden ser de materiales tejido o no tejidos. Se pueden seleccionar las fibras a partir de fibras naturales, fibras sintéticas, y combinaciones de las dos. Por medio de un ejemplo no limitante, los materiales adecuados que se pueden utilizar para formar una o más capas de la presente invención incluyen: celulosa, alginatos (por ejemplo, alginato de calcio), algodón, Rayón, Nylon, material acrílico, poliéster, poliuretano, espuma de poliuretano, un hidrogel y sus combinaciones.
Un apósito para heridas de la presente invención incluye uno o más agentes antimicrobianos. Son posibles numerosos agentes antimicrobianos alternativos. Los agentes antimicrobianos adecuados incluyen pero no se limitan a una clorhexidina, una sal de clorhexidina, un triclosán, una Polimixina, una tetraciclina, un aminoglicósido (por ejemplo, gentamicina o Tobramycin®), una rifampicina, una bacitracina, una eritromicina, una neomicina, un cloranfenicol, un miconazol, una quinolona, una penicilina, un nonoxinol 9, un ácido fusídico, una cefalosporina, una mupirocina, un metronidazol, una secropina, una protegrina, una bacteriolcina, una defensina, una nitrofurazona, una mafenida, araciclovir, una vancomicina, una clindamicina, una lincomicina, una sulfonamida, una norfloxacina, una pefloxacina, un ácido nalidízico, un ácido oxálico, un ácido enoxacínico, una ciprofloxacina, una biguanida, sus combinaciones y similares. En algunas realizaciones el agente antimicrobiano comprende polihexametileno biguanida (PHMB) y/o sus derivados.
Un apósito para heridas de la presente invención incluye además un agente que contiene cinc. Se puede utilizar cualquier agente que contenga el cinc adecuado. A modo de ejemplo no limitante, se contemplan los agentes que contienen cinc tales como un alginato de cinc o un aspartato de cinc, sus combinaciones y similares. Los agentes que contienen cinc pueden mejorar la velocidad de cicatrización de la herida volviendo por tanto el apósito para heridas más eficaz en el combate y/o la prevención de la infección, sin la necesidad de aumentar los niveles de agente microbiano contenidos en el anterior. La combinación con alginato proporciona capacidades de absorción de la humedad. Este aspecto de la presente invención evita de manera ventajosa los problemas originados por los efectos irritantes de algunos agentes antimicrobianos, tales como GCH, especialmente cuando se aplican a la piel en niveles mayores de concentración.
Como componente adicional, un apósito para heridas formado de acuerdo con los principios de la presente invención puede incluir uno o más agentes antimicrobianos adicionales. Por medio de un ejemplo no limitante, los agentes antimicrobianos adicionales adecuados incluyen, pero no se limitan a: polietileno hexametileno biguanida (PEHMB), iones metálicos, plata, cinc, cobre y sus combinaciones.
Los apósitos para heridas a modo de ejemplo pueden, por supuesto, incluir ingredientes o agentes activos adicionales tales como, por ejemplo, un agente terapéutico, un agente organoléptico, un factor de crecimiento, un analgésico, un agente secuestrante tisular, un agente hemostático, un inhibidor de la proteína, colágeno, enzimas, un agente antitrombótico, un anestésico, un analgésico, un agente antiinflamatorio, un agente anticanceroso, una sustancia vasodilatadora, óxido nítrico, vaselina, vitaminas, taurina, capsaicina, mentol, un agente de cicatrización de heridas, un agente angiogénico, un agente angiostático, un agente inmunoestimulante, un agente de sellado de la piel, un agente para inducir el crecimiento bacteriano direccional, un agente para impartir actividad bactericida o bacteriostática, un agente de transferencia de electrones para desestabilizar o destruir la acción metabólica de los microbios y/o la formación de biopelícula, sus combinaciones y similares. La liberación de agentes activos puede estimularse mediante una variedad de medios, tales como, por ejemplo, campo o señal eléctrica, temperatura, tiempo, presión, humedad y luz que incluyen, por ejemplo, luz ultravioleta, energía de ultrasonidos, sonicación, sus combinaciones y similares.
De acuerdo con la presente invención, cualquiera de los agentes antimicrobianos que contienen cinc o agentes activos adicionales mencionados anteriormente se pueden combinar directamente con el material que forma las capas del apósito para heridas. Alternativamente, cualquiera de los agentes mencionados anteriormente puede contenerse, y posteriormente liberarse, mediante un agente de liberación. Se puede utilizar cualquier agente de liberación adecuado. Por medio de un ejemplo no limitante, los agentes de liberación adecuados incluyen; un hidrogel, almidón en polvo, vidrio de fosfato soluble o una película de almidón.
El agente antimicrobiano, agente que contiene cinc, y/u otro agente mencionado anteriormente se puede imprimir opcionalmente o aplicarse de otra manera a una o más capas de un apósito para heridas para proporcionar una concentración deseada o un gradiente de concentración de uno o más de estos agentes en y/o el interior del apósito. Por ejemplo, uno o más de los agentes se pueden aplicar por separado, o en combinación, en un diseño específico que corresponde a la zona de la herida, a fines de optimizar los efectos antimicrobianos y de cicatrización de la herida. Alternativamente, el agente antimicrobiano y/o el agente que contiene cinc se pueden combinar de manera uniforme y homogénea con el material que forma una o más capas del apósito para heridas.
Los apósitos para heridas formados de acuerdo con la presente invención se pueden proporcionar en numerosas configuraciones, que tienen numerosas combinaciones de características diferentes. En el debate que sigue, se pueden incluir cualquiera de los agentes o aditivos anteriormente mencionados en las configuraciones ilustrativas que se describen a continuación, a no ser que se indique otra cosa.
De acuerdo con una modificación opcional, todas las capas del apósito para heridas pueden contener una combinación de agente antimicrobiano y agente que contiene cinc.
Por ejemplo, se puede formar un apósito para heridas con al menos tres capas distintas; una primera capa interna (por ejemplo, 30) y unas capas externas adyacentes (por ejemplo, 20, 40). De acuerdo con un ejemplo específico no limitante, las capas individuales se pueden formar a partir de algodón, espuma y película, y se pueden proporcionar en cualquier orden de disposición. La capa interna puede ser sustancialmente hidrófila, mientras que una o más de las capas externas puede ser sustancialmente hidrófoba. Opcionalmente, una o más de las capas externas se proporcionan con un acabado hidrófilo. Aunque un agente antimicrobiano, y posiblemente también un agente que contiene cinc, puede liberarse desde el material de la capa interna del tejido, el tratamiento antimicrobiano del tejido permite principalmente al apósito funcionar como una barrera para la contaminación de la herida a partir de fuentes externas a la herida. Además, debido a las características absorbentes del apósito, se evita que los microbios absorbidos en el interior de la capa interna escapen a través del apósito. El término “sustancialmente hidrófilo” describe la función del material de la capa interna. Esto distingue también el material de la capa interna sobre la función del material de la capa externa “sustancialmente hidrófobo”, que proporciona una propiedad de barrera antimicrobiana y atenúa o reduce la liberación de un agente antimicrobiano lejos del apósito. La retención mejorada del agente antimicrobiano en el interior de la capa interna disminuye también la biocarga, es decir, el crecimiento y el número de células, en el interior del apósito durante el uso. Como una modificación opcional del anterior, se puede proporcionar el agente que contiene cinc en la capa interna, y proporcionarse el agente antimicrobiano en una o más de las capas externas adyacentes.
Cuando los apósitos para heridas de la presente invención se forman a partir de materiales fibrosos, el apósito para heridas se puede proporcionar con una combinación de agentes antimicrobianos y agentes que contienen cinc mediante tratamiento de diferentes fibras con diferentes agentes, combinando a continuación las fibras de una manera deseada para proporcionar al apósito para heridas un efecto o comportamiento antimicrobiano particular. De esta manera, por ejemplo, el apósito para heridas puede comprender una o más capas formadas como una mezcla homogénea de las fibras tratadas descritas anteriormente. Alternativamente, se puede formar el apósito para heridas a partir de una o más capas compuestas de fibras que varían en densidad y niveles de tratamiento antimicrobiano. Por medio de un ejemplo no limitante, se pueden tratar fibras adecuadas tales como celulosa, Rayón, etc., y unirse a PHMB a diversas concentraciones. Se pueden componer otras fibras, tales como nylon o poliéster, con un agente que contiene cinc en la resina base, e hilarse en forma de fibra. Como una alternativa, se puede construir la fibra a partir de dos componentes básicos. Específicamente, la fibra puede comprender un núcleo interno y una vaina externa que contiene una cantidad relativamente elevada de un agente antimicrobiano y/o que contiene cinc. Se contempla que son posibles otras combinaciones de agentes antimicrobianos. Por medio de ejemplo no limitante, otros agentes antimicrobianos basados en metal, tales como aquellos basados en plata o cobre, podrían utilizarse en combinación con el agente que contiene cinc.
Todas las cifras que expresan cantidades de ingredientes, constituyentes, condiciones de reacción, y así sucesivamente usados en la memoria descriptiva se entiende que se encuentran modificados en todos los casos por el término “aproximadamente”. A pesar de que los intervalos y parámetros numéricos demuestran que, el amplio alcance del tema objeto presentado en la presente memoria descriptiva son aproximaciones, los valores numéricos que se muestran se indican de la manera más precisa posible. Cualquier valor numérico, sin embargo, puede contener de manera inherente algunos errores como es evidente, debido a la desviación estándar encontrada en sus respectivas técnicas de medida.
En una realización, los apósitos para heridas incluyen además aquellos en los que la segunda y la tercera capas externas comprenden un acabado hidrófilo.
En otra realización, los apósitos para heridas incluyen además aquellos en los que una o más capas se forman a partir de una combinación de fibras, comprendiendo la combinación de fibras al menos una primera fibra y una segunda fibra, en la que la primera fibra se trata con al menos el primer agente antimicrobiano, y la segunda fibra se trata con al menos un segundo agente.
En otra realización, los apósitos para heridas incluyen además aquellos en los que una o más capas se forman a partir de una mezcla homogénea de fibras, comprendiendo la combinación de fibras al menos una primera fibra y una segunda fibra, en la que la primera fibra se trata con al menos un primer agente antimicrobiano, y la segunda fibra se trata con al menos un segundo agente.
En otra realización, los apósitos para heridas incluyen además aquellos en los que una o más capas se forman a partir de una combinación de fibras, comprendiendo la combinación de fibras al menos una primera fibra y una segunda fibra, en la que la primera fibra se trata con al menos el primer agente antimicrobiano, y la segunda fibra se trata con al menos un segundo agente, y en la que la cantidad de la primera fibra presente en el apósito para heridas es diferente de la cantidad de la segunda fibra presente en el apósito para heridas.
En otra realización, los apósitos para heridas incluyen además aquellos en los que se usa un agente de liberación para contener y liberar al menos uno de los agentes.
En otra realización, los apósitos para heridas incluyen además aquellos en los que el agente de liberación 5 comprende uno o más de: un hidrogel, un almidón en polvo, un vidrio de fosfato soluble o una película de almidón.
En otra realización, los apósitos para heridas incluyen aquellos que comprenden además un adhesivo.
En otra realización, los apósitos para heridas incluyen aquellos que comprenden además al menos un agente 10 antimicrobiano y el agente que contiene cinc dispuestos en un diseño en al menos una de las capas.
Claims (15)
- REIVINDICACIONES
- 1.
- Un apósito para heridas que comprende una primera capa (30), una segunda capa (20) y una tercera capa (40), caracterizado porque cada una de la primera, segunda y tercera capas (30, 20, 40) contiene al menos un agente antimicrobiano y al menos un agente que contiene cinc.
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- 2.
- El apósito para heridas (10) de la reivindicación 1, en el que la primera capa (30) es sustancialmente hidrófila, y la segunda y tercera capas (20, 40) son capas externas y son sustancialmente hidrófobas.
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- 3.
- El apósito para heridas (10) de las reivindicaciones 1 ó 2, en el que la segunda y tercera capas (20, 40) comprenden un acabado hidrófilo.
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- 4.
- El apósito para heridas (10) de la reivindicación 1, que comprende además un agente de liberación para contener y liberar al menos uno de los agentes.
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- 5.
- El apósito para heridas (10) de la reivindicación 4, en el que el agente de liberación comprende uno o más de entre: un hidrogel, almidón en polvo, un vidrio de fosfato soluble o una película de almidón.
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- 6.
- El apósito para heridas (10) de las reivindicaciones 1 a 5, que comprende además un adhesivo.
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- 7.
- El apósito para heridas (10) de las reivindicaciones 1 a 6, en el que al menos uno del agente antimicrobiano y el agente que contiene cinc está dispuesto en un diseño en al menos una de la primera, segunda y tercera capas (30, 20, 40).
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- 8.
- El apósito para heridas (10) de las reivindicaciones 1 a 7, en el que al menos un agente que contiene cinc comprende aspartato de cinc.
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- 9.
- El apósito para heridas (10) de las reivindicaciones 1 a 8, en el que al menos una de la segunda y la tercera capas (20, 40) es una capa en contacto con la piel.
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- 10.
- El apósito para heridas (10) de cualquiera de las reivindicaciones 1 a 9, en el que una o más de la primera, la segunda y la tercera capas (30, 20, 40) se forman, al menos en parte, por una o más de: fibras naturales, fibras sintéticas, celulosa, algodón, Rayón, Nylon, material acrílico, poliéster, poliuretano, espuma de poliuretano, un hidrogel, una película de almidón, alginato de calcio y un material absorbible y sus combinaciones.
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- 11.
- El apósito para heridas (10) de cualquiera de las reivindicaciones 1 a 10, en el que al menos un agente antimicrobiano comprende uno o más de: polihexametileno biguanida (PHMB), un derivado de PHMB, polietilen hexametilen biguanida (PEHMB), plata, cobre y sus combinaciones.
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- 12.
- El apósito para heridas (10) de cualquiera de las reivindicaciones 1 a 11, en el que al menos un agente que contiene cinc comprende uno o más de alginato de cinc y aspartato de cinc.
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- 13.
- El apósito para heridas (10) de cualquiera de las reivindicaciones 1 a 12, que comprende además uno o más de: un agente terapéutico, un agente organoléptico, un factor de crecimiento, un analgésico, un agente secuestrante tisular, un agente hemostático, un inhibidor de la proteína, colágeno, enzimas, un agente antitrombogénico, un anestésico, un analgésico, un agente antiinflamatorio, un agente anticanceroso, una sustancia vasodilatadora, óxido nítrico, vaselina, vitaminas, taurina, capsaicina, mentol, un agente cicatrizador de heridas, un agente angiogénico, un agente angiostático, un agente inmunoestimulador, un agente de sellado de la piel, un agente para inducir el crecimiento bacteriano direccional, un agente para impartir actividad bactericida o bacteriostática, un agente de transferencia de electrones para desestabilizar o destruir la acción metabólica de los microbios y/o la formación de biopelícula, y sus combinaciones.
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- 14.
- El apósito para heridas (10) de cualquiera de las reivindicaciones 1 a 13, en el que al menos una de la primera capa, la segunda capa, y la tercera capa (30, 20, 40) se forma a partir de alginato de calcio y en el que al menos un agente antimicrobiano es polihexametileno biguanida (PHMB).
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- 15.
- El apósito para heridas (10) de cualquiera de las reivindicaciones 1 a 14, en el que al menos una de la primera capa, la segunda capa, y la tercera capa (30, 20, 40) se forma a partir de fibra de algodón, en el que al menos una de la primera capa, la segunda capa y la tercera capa (30, 20, 40) se forma a partir de una espuma, y en el que al menos una de la primera capa, la segunda capa, y la tercera capa (30, 20, 40) se forma a partir de una película.
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| US790814P | 2006-04-11 | ||
| PCT/US2007/008771 WO2007120616A2 (en) | 2006-04-11 | 2007-04-11 | Wound dressings with anti-microbial and zinc-containing agents |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2394111T3 true ES2394111T3 (es) | 2013-01-21 |
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| Application Number | Title | Priority Date | Filing Date |
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| ES07755143T Active ES2394111T3 (es) | 2006-04-11 | 2007-04-11 | Apósitos para heridas con agentes antimicrobianos y que contienen cinc |
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| EP (1) | EP2004246B1 (es) |
| JP (1) | JP5345930B2 (es) |
| AU (1) | AU2007238826B2 (es) |
| CA (1) | CA2646289C (es) |
| ES (1) | ES2394111T3 (es) |
| MX (1) | MX2008012555A (es) |
| WO (1) | WO2007120616A2 (es) |
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