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Emulsión Lipídica Inyectable De Nistatina Como Alternativa a Los Tratamientos Clásicos De Infecciones Fúngicas Invasivas

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Emulsión Lipídica Inyectable De Nistatina Como Alternativa a Los Tratamientos Clásicos De Infecciones Fúngicas Invasivas Emulsión lipídica inyectable de nistatina como alternativa a los tratamientos clásicos de infecciones fúngicas invasivas Deiry Margot Marín Quintero ADVERTIMENT. La consulta d’aquesta tesi queda condicionada a l’acceptació de les següents condicions d'ús: La difusió d’aquesta tesi per mitjà del servei TDX (www.tdx.cat) i a través del Dipòsit Digital de la UB (diposit.ub.edu) ha estat autoritzada pels titulars dels drets de propietat intel·lectual únicament per a usos privats emmarcats en activitats d’investigació i docència. No s’autoritza la seva reproducció amb finalitats de lucre ni la seva difusió i posada a disposició des d’un lloc aliè al servei TDX ni al Dipòsit Digital de la UB. No s’autoritza la presentació del seu contingut en una finestra o marc aliè a TDX o al Dipòsit Digital de la UB (framing). Aquesta reserva de drets afecta tant al resum de presentació de la tesi com als seus continguts. En la utilització o cita de parts de la tesi és obligat indicar el nom de la persona autora. ADVERTENCIA. La consulta de esta tesis queda condicionada a la aceptación de las siguientes condiciones de uso: La difusión de esta tesis por medio del servicio TDR (www.tdx.cat) y a través del Repositorio Digital de la UB (diposit.ub.edu) ha sido autorizada por los titulares de los derechos de propiedad intelectual únicamente para usos privados enmarcados en actividades de investigación y docencia. No se autoriza su reproducción con finalidades de lucro ni su difusión y puesta a disposición desde un sitio ajeno al servicio TDR o al Repositorio Digital de la UB. No se autoriza la presentación de su contenido en una ventana o marco ajeno a TDR o al Repositorio Digital de la UB (framing). Esta reserva de derechos afecta tanto al resumen de presentación de la tesis como a sus contenidos. En la utilización o cita de partes de la tesis es obligado indicar el nombre de la persona autora. WARNING. On having consulted this thesis you’re accepting the following use conditions: Spreading this thesis by the TDX (www.tdx.cat) service and by the UB Digital Repository (diposit.ub.edu) has been authorized by the titular of the intellectual property rights only for private uses placed in investigation and teaching activities. Reproduction with lucrative aims is not authorized nor its spreading and availability from a site foreign to the TDX service or to the UB Digital Repository. Introducing its content in a window or frame foreign to the TDX service or to the UB Digital Repository is not authorized (framing). Those rights affect to the presentation summary of the thesis as well as to its contents. In the using or citation of parts of the thesis it’s obliged to indicate the name of the author. UNIVERSITAT DE BARCELONA FACULTAT DE FARMACIA 5 EMULSIÓN LIPÍDICA INYECTABLE DE NISTATINA COMO ALTERNATIVA A LOS TRATAMIENTOS CLÁSICOS DE INFECCIONES FÚNGICAS INVASIVAS. DEIRY MARGOT MARÍN QUINTERO 2013 UNIVERSITAT DE BARCELONA FACULTAT DE FARMACIA 5 EMULSIÓN LIPÍDICA INYECTABLE DE NISTATINA COMO ALTERNATIVA A LOS TRATAMIENTOS CLÁSICOS DE INFECCIONES FÚNGICAS INVASIVAS. Memoria presentada por Deiry Margot Marín Quintero para optar al título de doctor por la Universidad de Barcelona Directores: Ana Cristina Calpena Campmany Alfonso del Pozo Carrascosa DEIRY MARGOT MARÍN QUINTERO 2013 A Dios, Quien ha sido mi luz en este camino, A mis padres Rafael y Faride mi gran inspiración, A Maider quien es mi hermana y mi ángel, A Martin mi esposo Con el que he compartido mis alegrías y tristezas. Agradecimientos Después de concluir una empresa de tal envergadura y haciendo una mirada retrospectiva, me vienen a la memoria muchas personas que han contribuido al éxito y feliz término de este trabajo. Trabajo que ha representado mucho tiempo y sacrificios a nivel personal y profesional y que era el motivo principal por el que decidí dejar mi tierra y mi familia para emigrar a España. En primer lugar, quiero agradecer a la Dra. Lyda Halbaut, y a la comisión que me aceptó como alumna cuando me presente al doctorado, allá a principios del año 2002, por darme la oportunidad de venir a estudiar a la Universidad de Barcelona y de vivir en una ciudad tan maravillosa como Barcelona. Seguidamente, quiero agradecer al Dr. Alfonso del Pozo Carrascosa y a la Dra. Ana Cristina Calpena Company, por aceptar el reto de dirigir esta tesis, la confianza, los consejos, el tiempo y esfuerzo dedicados en cada uno de los pasos que hemos dado hasta su culminación. Al Dr. Francisco Fernández Campos, por ayudarme a organizar las ideas, el trabajo instrumental y guiarme en los entresijos de los estudios farmacocinéticos, fundamentales para completar esta tesis. Además de su amistad, su buena disposición y sus consejos prácticos y objetivos. A la Dra Beatriz Clares Naveros, por su experiencia, su constancia y tenacidad a la hora de lidiar con los editores de revistas, lo que nos ha permitido publicar este trabajo. A la Dra. Nuria Bozal de Febrer, por aportar sus conocimientos y su experiencia adquirida en el campo de la microbiología, siendo una guía eficaz en el estudio de los hongos y levaduras. Al Dr. Albert Mannich, del CSIC, por sus consejos y enseñanzas en el campo de la estadística y la planificación de experiencias. Al Dr. Joan Estelrich, por iniciarme en el estudio de espectrometría de correlación fotónica y permitirnos utilizar el único aparato de PCS, que existía en la facultad, en aquel momento. A Rosa Aparicio, quien siempre nos ayudó en las gestiones de proveedores de las materias primas empleadas en esta investigación, siendo una persona eficiente y colaboradora. A la licenciada Alice Bertorello, por su ayuda y cooperación en la realización de los cientos de experimentos que permitieron ensayar diferentes co-emulgentes para antifungicos, en su paso como becaria de la unidad de tecnología farmacéutica. Además de brindarme su amistad, compartir experiencias de vida, y darme ideas y animo en los momentos difíciles. A Ana María Sierra Villar, Mauren Arias Acosta y Paola Delgado Hernández, quienes comenzaron esta aventura conmigo y aunque la vida nos ha llevado por diferentes caminos, siempre agradeceré su cariño, sus consejos y apoyo en los momentos de flaqueza y su gran ánimo y alegría para afrontar los retos de la vida. A Claudio Díaz, por enseñarme a ser tolerante y a ver la vida desde diferentes ópticas, gracias por ser mi soporte y mi confidente a pesar del tiempo y la distancia. Al resto de mis amigos, que me han acompañado en este camino, q es la vida… A Bernat, Paz y Zenon (QEPD) quienes fueron mi familia adoptiva en mis primeros años en esta ciudad. A Claudia M, Fernando D, Mauri L, Ivanna, Nico P, Davide P, Adrian S y Alessia B, con los que he compartido grandes experiencias y quienes significan alegría, confianza y cariño. Por último, quiero agradecer a mi familia, quienes han salvado la barrera del tiempo y los miles de kilómetros que nos separan, para seguir siendo un pilar fundamental en mi vida. Mis padres Rafael y Faride, mi gran ejemplo de vida, siempre han creído que yo puedo llegar tan lejos como me proponga y eso ha sido mi gran fuerza. A Mis hermanos Rafa y Gelmy quienes con su cariño, consejos y bromas me hacen la vida más feliz. A Maider, mi alma gemela, quien nació conmigo, la persona responsable de que nunca me haya sentido sola y con la que estoy unida en espíritu y amor. A Mile, mi hermanita pequeña, la alegría de la huerta! Su energía y amor siempre me han inspirado. A Martin, por el tiempo restado de su compañía en el desarrollo de esta memoria, quien es mi compañero de viaje, gracias por tu amor, tus cuidados y por ser mí gran apoyo en los momentos difíciles y mí fuente de alegría e inspiración. Y a todos los que de una u otra forma, han contribuido al feliz término de esta monografía, ¡Muchas gracias! Resumen La nistatina es un polieno macrólido, antifúngico de amplio espectro, restringido en principio al uso tópico, debido a su toxicidad tras administración sistémica. Los objetivos de este trabajo son el diseño, desarrollo y optimización de una emulsión parenteral de nistatina apta para su administración por vía intravenosa. Se diseñó y optimizó un sistema de circuito cerrado que permitió la elaboración de las emulsiones lipídicas inyectables (ELI) por sonicación. La formulación resultante se compara con un producto comercial disponible en el mercado (Intralipid® 20%). Las condiciones de fabricación se optimizaron mediante un diseño factorial. Las formulaciones se evaluaron en términos de parámetros físico-químicos, estabilidad, perfil de liberación y l actividad antimicrobiana. Los valores de tamaño medio de gota oscilaron entre 192,5 y 143,0 nm, el índice de polidispersidad entre 0170 y 0135, el potencial zeta entre -46 y -44 mV, el pH entre 711 y 753 y el volumen (LD99) entre 580 y 670 nm. La formulación de nistatina seleccionada (NYS- ELI 4), integrada por aceite de soja (30%), lecitina de soja (2%), Solutol ® HS 15 (4%) y glicerol (2,25%) es físicamente estable durante al menos 60 días. Los estudios in vitro de liberación de fármaco de esta formulación sugieren un perfil de liberación sostenida, presentando además una actividad antimicrobiana más alta que el fármaco libre, por lo que se presenta como un potencial sistema de administración de fármacos para el tratamiento de infecciones fúngicas sistémicas. Abstract Nystatin is a polyene macrolide with broad antifungal spectrum restricted to topical use owing to its toxicity upon systemic administration. The aims of this work were the design, development and optimization of Nystatin loaded lipid emulsion for intravenous administration.
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