{"id":8701,"date":"2021-10-21T19:35:29","date_gmt":"2021-10-21T19:35:29","guid":{"rendered":"https:\/\/www.amarintech.com\/?p=8701"},"modified":"2022-05-23T11:16:18","modified_gmt":"2022-05-23T11:16:18","slug":"evaluation-of-the-adhesion-of-a-transdermal-patch-pros-cons-of-proposed-methods","status":"publish","type":"post","link":"https:\/\/amarintech.com\/es\/evaluation-of-the-adhesion-of-a-transdermal-patch-pros-cons-of-proposed-methods\/","title":{"rendered":"Evaluaci\u00f3n de Adhesi\u00f3n en un Parche Transd\u00e9rmico: Pros y Cons de M\u00e9todos Propuestos"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"8701\" class=\"elementor elementor-8701\">\n\t\t\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-c78867c elementor-section-height-min-height she-header-yes elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"c78867c\" 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d=\"M766.1,28.9c-200-57.5-266,65.5-395.1,19.5C242,1.8,242,5.4,184.8,20.6C128,35.8,132.3,44.9,89.9,52.5C28.6,63.7,0,0,0,0 h1000c0,0-9.9,40.9-83.6,48.1S829.6,47,766.1,28.9z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c82bb91\" data-id=\"c82bb91\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2e6195d elementor-widget elementor-widget-heading\" data-id=\"2e6195d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Evaluaci\u00f3n de Adhesi\u00f3n en un Parche Transd\u00e9rmico: Pros y Cons de M\u00e9todos Propuestos<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0a0f96 elementor-widget elementor-widget-text-editor\" data-id=\"d0a0f96\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"p1\"><b>Miguel Fortuny,<\/b>Gerente de Investigaci\u00f3n Cl\u00ednica<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-62b6c1f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"62b6c1f\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-97230eb\" data-id=\"97230eb\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-003eebf elementor-widget elementor-widget-spacer\" data-id=\"003eebf\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a8f378 elementor-widget elementor-widget-text-editor\" data-id=\"5a8f378\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"p1\">La correcta adhesi\u00f3n de un parche transd\u00e9rmico a la piel durante el tiempo de uso establecido es crucial para garantizar la administraci\u00f3n efectiva de la dosis declarada en el prospecto.<\/p><p class=\"p1\"><b>En este art\u00edculo profundizamos sobre los diferentes m\u00e9todos para cuantificar el porcentaje adherido del parche, analizando las ventajas y desventajas de cada uno.<\/b><\/p><p>\u00a0<\/p><h2 class=\"p1\"><b>La importancia de la adhesi\u00f3n<\/b><\/h2><p>\u00a0<\/p><p class=\"p3\">La adhesi\u00f3n de un parche es actualmente un requisito regulatorio que involucra una evaluaci\u00f3n formal para aprobar un producto gen\u00e9rico.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p><p class=\"p3\">Consecuencia de ello es que existen gu\u00edas internacionales, principalmente FDA y EMA, que han establecido el criterio estad\u00edstico de no inferioridad para la adhesi\u00f3n como un requerimiento a cumplimentar, adem\u00e1s de la evaluaci\u00f3n de bioequivalencia y de sensibilizaci\u00f3n\/irritaci\u00f3n, para la aprobaci\u00f3n del registro de un producto medicinal transdermal gen\u00e9rico.<\/p><p class=\"p1\">La FDA emplea un sistema de puntajes (scores) para cuantificar adhesi\u00f3n (cada uno de ellos abarcando un rango de porcentajes diferentes en amplitud) y, como indicador principal, compara promedios de puntajes de adhesi\u00f3n observados durante el uso de los productos (Test y Referencia). La EMA, por su parte, considera principalmente los porcentajes de adhesi\u00f3n obtenidos a lo largo del uso del producto y hace foco en el \u00faltimo tiempo de evaluaci\u00f3n para la comparaci\u00f3n formal.<\/p><p class=\"p1\">Para obtener los porcentajes de<span class=\"Apple-converted-space\">\u00a0 <\/span>adhesi\u00f3n (del cual derivan los puntajes FDA), las gu\u00edas sugieren emplear una evaluaci\u00f3n visual -tras entrenar a los observadores- o el empleo de moldes con matrices de puntos. Esto se vuelve un desaf\u00edo importante cuando la cubierta de los parches transd\u00e9rmicos es opaca.<\/p><p class=\"p1\">Dada la condici\u00f3n requerida para cumplir el criterio de no inferioridad en adhesi\u00f3n, y considerando tambi\u00e9n que los despegues de un parche transd\u00e9rmico son mayormente irregulares durante el uso y pueden presentarse en varias zonas, el empleo de moldes con o sin grilla (matriz) sugiere ser m\u00e1s adecuado que la observaci\u00f3n visual entrenada para obtener la precisi\u00f3n adecuada.<\/p><p class=\"p1\">En este art\u00edculo se plantean las ventajas y desventajas de dos m\u00e9todos cuantitativos que han probado ser pr\u00e1cticos y que se est\u00e1n empleando actualmente para cuantificar adhesi\u00f3n de parches gen\u00e9ricos durante los ensayos cl\u00ednicos requeridos para el registro de productos medicinales transdermales. Se menciona, adem\u00e1s, un m\u00e9todo alternativo que propone el empleo de im\u00e1genes y software.<\/p><h2 class=\"p1\"><b><br \/>M\u00e9todos Cuantitativos para Evaluar la Adhesi\u00f3n de Parches<\/b><\/h2><p>\u00a0<\/p><p class=\"p1\">Se analizan dos m\u00e9todos para cuantificar el porcentaje adherido del parche durante su uso:<\/p><ol><li><strong><span class=\"s1\"><i>Molde con Cuadr\u00edcula y Relaci\u00f3n de N\u00famero de Cuadros:<\/i><\/span>:<span class=\"Apple-converted-space\">\u00a0<br \/><br \/><\/span><\/strong>Consiste en el calcado de las zonas despegadas en una cuadr\u00edcula transparente preimpresa con la forma exacta del parche, y relacionar luego el n\u00famero de cuadros que cubren \u00e1reas despegadas y totales de la siguiente manera:<br \/><br \/>% Adhesi\u00f3n= [1 - (Suma de cuadros con despegues) \/ Total de cuadros)] x 100%<br \/><br \/>Seg\u00fan la recomendaci\u00f3n de las gu\u00edas que sugieren el uso de este m\u00e9todo, los despegues que ocupen \u00e1reas parciales de la cuadr\u00edcula deben ser considerados como cuadro completo ocupado por tal despegue.<br \/><br \/><\/li><li><i><\/i><strong><span class=\"s1\"><i>Molde sin Cuadr\u00edcula y Relaci\u00f3n de Pesos de Areas:<br \/><br \/><\/i><\/span><\/strong>Consiste en el calcado de las zonas despegadas en un molde transparente con la forma exacta del parche, obtener una copia en papel del mismo, recortar las siluetas de las \u00e1reas despegadas y del \u00e1rea total, y relacionar los pesos de las mismas seg\u00fan esta ecuaci\u00f3n:<br \/><br \/>% Adhesi\u00f3n= [1 - (Suma de pesos de \u00e1reas despegadas \/ Peso \u00e1rea total)] x 100%<\/li><\/ol><p>\u00a0<\/p><p class=\"p1\">Cualquiera de estas metodolog\u00edas para cuantificar adhesi\u00f3n adolece principalmente del sesgo del operador y de la necesidad de apoyar el molde sobre el parche aplicado, lo que podr\u00eda generar una presi\u00f3n no deseada sobre el parche y forzar un repegado, alterando la medici\u00f3n (la mayor\u00eda de los parches transd\u00e9rmicos emplean adhesivos sensibles a la presi\u00f3n en sus formulaciones). Sin embargo, tales sesgos deber\u00edan estar compensados si un mismo operador entrenado realiza la evaluaci\u00f3n de los productos Test y Referencia en cada per\u00edodo de tratamiento del estudio cl\u00ednico que eval\u00faa adhesi\u00f3n, ejercitando un apoyo suave y cuidadoso del molde sobre el parche aplicado.<\/p><p class=\"p1\">En general, los despegues de un sistema transdermal son irregulares y\/o pueden presentarse en diferentes zonas del parche. En este sentido, el empleo de una cuadr\u00edcula para el c\u00e1lculo de \u00e1reas despegadas no ofrecer\u00eda ventajas de precisi\u00f3n en la medici\u00f3n respecto del m\u00e9todo de relaci\u00f3n de pesos, m\u00e1xime si la cubierta del parche es opaca. En este \u00faltimo caso se requiere un entrenamiento intensivo al operador, que incluye la observaci\u00f3n desde \u00e1ngulos laterales y condiciones lum\u00ednicas adecuadas para maximizar la precisi\u00f3n en el calcado de las zonas despegadas en el molde.<\/p><h3 class=\"p5\"><b><br \/>\u00bfCu\u00e1les son las ventajas y desventajas de estos m\u00e9todos?<\/b><\/h3><p>\u00a0<\/p><p class=\"p5\"><span class=\"s1\"><i>M\u00e9todo 1: Molde con Cuadr\u00edcula y Relaci\u00f3n de N\u00famero de Cuadros<\/i><\/span><\/p><p class=\"p3\">Escenario: Una misma \u00e1rea despegada del parche, en diferentes zonas de la cuadr\u00edcula pre-impresa en el molde. (El ejemplo presentado abajo fue magnificado para explicar mejor el sesgo)<\/p><p class=\"p3\">M\u00e9todo: Contar todos los cuadros donde est\u00e1 presente la figura despegada calcada y relacionarlos con el n\u00famero total de cuadros, para obtener el % de despegue, y por diferencia, el % de adhesi\u00f3n.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-inner-section elementor-element elementor-element-3821492 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3821492\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-c57d272\" data-id=\"c57d272\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-45d6f4e elementor-widget elementor-widget-image\" data-id=\"45d6f4e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama1.png\" class=\"attachment-large size-large wp-image-8705\" alt=\"\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama1.png 400w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama1-300x300.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama1-150x150.png 150w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama1-12x12.png 12w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-28177ad\" data-id=\"28177ad\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5cc02e9 elementor-widget elementor-widget-text-editor\" data-id=\"5cc02e9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"p1\">% Adhesi\u00f3n= [1 - (1\/25)] x 100%<\/p><p class=\"p1\">% Adhesi\u00f3n= 96%<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-8c29bba\" data-id=\"8c29bba\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-37365d5 elementor-widget elementor-widget-image\" data-id=\"37365d5\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama2.png\" class=\"attachment-large size-large wp-image-8706\" alt=\"\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama2.png 400w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama2-300x300.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama2-150x150.png 150w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama2-12x12.png 12w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-e6a687b\" data-id=\"e6a687b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-18f72b2 elementor-widget elementor-widget-text-editor\" data-id=\"18f72b2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"p1\">% Adhesi\u00f3n= [1 \u2013 (4\/25)] x 100%<\/p><p class=\"p1\">% Adhesi\u00f3n= 84%<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-7f08b77 elementor-widget elementor-widget-text-editor\" data-id=\"7f08b77\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h4 class=\"p1\" style=\"padding-left: 40px;\">Pros:<\/h4><ul><li style=\"list-style-type: none;\"><ul class=\"ul1\"><li class=\"li2\">Se menciona como opci\u00f3n de m\u00e9todo en las gu\u00edas internacionales<\/li><li class=\"li2\">No requiere balanza anal\u00edtica para obtener la medici\u00f3n<\/li><\/ul><\/li><\/ul><h4 class=\"p4\" style=\"padding-left: 40px;\">Cons:<\/h4><ul><li style=\"list-style-type: none;\"><ul class=\"ul1\"><li class=\"li2\">Una misma \u00e1rea despegada, dependiendo de d\u00f3nde cae en la cuadr\u00edcula y de la cantidad de cuadros de la misma, puede arrojar porcentajes de adhesi\u00f3n significativamente diferentes al relacionar conteos de cuadros.<\/li><li class=\"li2\">Sobreestima el % de despegue cuando \u00e9ste abarca parcialmente otros cuadros de la grilla.<\/li><li class=\"li2\">Requiere apoyar suavemente el molde sobre el parche aplicado para calcar las zonas despegadas, para evitar\/minimizar el repegado de las mismas a la piel en la operaci\u00f3n.<\/li><li class=\"li2\">A mayor cantidad de cuadros en la grilla, mayor precisi\u00f3n, pero tambi\u00e9n mayor riesgo de equivocaci\u00f3n del operador en el conteo (cuanto m\u00e1s chico el cuadro, menor percepci\u00f3n si abarca o no el despegue).<\/li><li class=\"li2\">Si los parches son de diferente tama\u00f1o se debe ajustar el \u00e1rea de cada cuadro de la cuadr\u00edcula para mantener la misma precisi\u00f3n en la evaluaci\u00f3n. En otras palabras, los moldes deber\u00e1n ser diferentes en la cantidad de \u00e1reas de la cuadr\u00edcula.<\/li><li class=\"li2\">Para un parche con cubierta opaca, un molde con una cuadr\u00edcula dificulta a\u00fan m\u00e1s la identificaci\u00f3n y calcado de las zonas despegadas.<\/li><\/ul><\/li><\/ul><p>\u00a0<\/p><p class=\"p1\" style=\"padding-left: 80px;\"><span class=\"s1\"><b><i>M\u00e9todo 2: <\/i><\/b><\/span><span class=\"s1\"><b><i>Molde sin Cuadr\u00edcula y Relaci\u00f3n de Pesos de Areas<\/i><\/b><\/span><b><span class=\"Apple-converted-space\">\u00a0<\/span><\/b><\/p><p class=\"p1\" style=\"padding-left: 80px;\"><strong>Escenario:<\/strong> La misma \u00e1rea despegada, en diferentes zonas del molde.<\/p><p class=\"p1\" style=\"padding-left: 80px;\"><strong>M\u00e9todo:<\/strong> relacionar el peso de recortes de papel de las zonas despegadas con el peso correspondiente al \u00e1rea total del parche, para obtener el % de despegue, y por diferencia, el % de adhesi\u00f3n.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-inner-section elementor-element elementor-element-2f1c372 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2f1c372\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-7e59112\" data-id=\"7e59112\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d9b34d1 elementor-widget elementor-widget-image\" data-id=\"d9b34d1\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama3.png\" class=\"attachment-large size-large wp-image-8707\" alt=\"\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama3.png 400w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama3-300x300.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama3-150x150.png 150w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama3-12x12.png 12w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-a3b6436\" data-id=\"a3b6436\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-be368c6 elementor-widget elementor-widget-text-editor\" data-id=\"be368c6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"p1\">% Adhesi\u00f3n= [1 \u2013 (0.012mg \/ 0.302mg)] x 100%<\/p><p class=\"p1\">% Adhesi\u00f3n= 96%<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-adb1636\" data-id=\"adb1636\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6a359ef elementor-widget elementor-widget-image\" data-id=\"6a359ef\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama4.png\" class=\"attachment-large size-large wp-image-8708\" alt=\"\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama4.png 400w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama4-300x300.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama4-150x150.png 150w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama4-12x12.png 12w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-3f3425f\" data-id=\"3f3425f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bf09f5d elementor-widget elementor-widget-text-editor\" data-id=\"bf09f5d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"p1\">% Adhesi\u00f3n= [1 - (0.011mg \/ 0.292mg)] x 100%<\/p><p class=\"p1\">% Adhesi\u00f3n= 96%<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-677db80 elementor-widget elementor-widget-spacer\" data-id=\"677db80\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9989b3 elementor-widget elementor-widget-text-editor\" data-id=\"f9989b3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3 class=\"p1\"><span class=\"s1\"><b><i>\u00bfCu\u00e1les son las ventajas y desventajas de este m\u00e9todo?<\/i><\/b><\/span><\/h3><h4 class=\"p1\">Pros:<\/h4><ul class=\"ul1\"><li class=\"li2\">Para una misma \u00e1rea despegada, el % de adhesi\u00f3n obtenido es pr\u00e1cticamente id\u00e9ntico en cualquier sitio del molde.<\/li><li class=\"li2\">Se ha usado como opci\u00f3n para realizar estudios pivote que cuantificaron adhesi\u00f3n de parches transd\u00e9rmicos<\/li><li class=\"li2\">La variabilidad por diferencias en el gramaje del papel es despreciable en un sector reducido de la copia tomada del molde calcado, para hacer la evaluaci\u00f3n.<\/li><li class=\"li2\">Un molde sin cuadr\u00edcula permite identificar y calcar con mayor precisi\u00f3n las \u00e1reas despegadas en un parche con cubierta externa opaca.<\/li><\/ul><h4 class=\"p4\">Cons:<\/h4><ul class=\"ul1\"><li class=\"li2\">Requiere apoyar suavemente el molde sobre el parche aplicado para calcar las zonas despegadas, para evitar\/minimizar el repegado de las mismas a la piel en la operaci\u00f3n.<\/li><li class=\"li2\">Depende de la precisi\u00f3n del operador para recortar la figura de las zonas despegadas, que se asume ser\u00e1 similar a la del recorte del \u00e1rea total del molde (al ser el mismo operador). El sesgo queda mayormente compensado al hacer la relaci\u00f3n de pesos de las \u00e1reas recortadas.<\/li><\/ul><p>\u00a0<\/p><h4 class=\"p1\"><span class=\"s1\"><b><i>M\u00e9todo Alternativo \u2013 Fotograf\u00eda y software<\/i><\/b><\/span><\/h4><p class=\"p1\">Las gu\u00edas de FDA y EMA recomiendan obtener fotograf\u00edas del sitio de aplicaci\u00f3n para complementar la evaluaci\u00f3n de adhesi\u00f3n a los distintos tiempos durante el uso del parche.<\/p><p class=\"p1\">Sin embargo, y aun considerando que existen aplicaciones y software para obtener y procesar im\u00e1genes con gran precisi\u00f3n, no hay actualmente propuestas regulatorias concretas para incorporarlas como alternativas a los m\u00e9todos recomendados para la cuantificaci\u00f3n de la adhesi\u00f3n de un parche transd\u00e9rmico.<\/p><p class=\"p1\">El m\u00e9todo fotogr\u00e1fico y posterior cuantificaci\u00f3n por uso de software puede ser \u00fatil para evaluar en forma cuantitativa diferencias de tonalidad entre las \u00e1reas despegadas y aquellas bien adheridas y presenta la ventaja de no necesitar el apoyar un molde sobre el parche para evaluar adhesi\u00f3n, pero su aplicaci\u00f3n se ve limitada para parches con cubierta opaca.<\/p><p class=\"p1\">A modo de ejemplo, se consider\u00f3 el caso de los parches de buprenorfina o rotigotina, en los cuales la l\u00e1mina de soporte del parche es opaca y de color s\u00edmil piel.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p><p class=\"p1\">En las fotos que siguen, una con parche 100% adherido (izquierda) y la otra con un despegue parcial (derecha, con 50% del parche adherido), no es posible discernir la magnitud del despegue:<\/p><p>\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-inner-section elementor-element elementor-element-a37bbb2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a37bbb2\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-bb7aa73\" data-id=\"bb7aa73\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-99a1aa4 elementor-widget elementor-widget-image\" data-id=\"99a1aa4\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama5.png\" class=\"attachment-large size-large wp-image-8709\" alt=\"\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama5.png 400w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama5-300x300.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama5-150x150.png 150w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama5-12x12.png 12w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-ad6eea8\" data-id=\"ad6eea8\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bf6103a elementor-widget elementor-widget-image\" data-id=\"bf6103a\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama6.png\" class=\"attachment-large size-large wp-image-8710\" alt=\"\" srcset=\"https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama6.png 400w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama6-300x300.png 300w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama6-150x150.png 150w, https:\/\/amarintech.com\/wp-content\/uploads\/2021\/10\/ama6-12x12.png 12w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-18d8e9f elementor-widget elementor-widget-text-editor\" data-id=\"18d8e9f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u00a0<\/p><p>\u00a0<\/p><p class=\"p1\">Para estos productos con cubierta opaca, una fotograf\u00eda no permite obtener la precisi\u00f3n necesaria para obtener el porcentaje de adhesi\u00f3n y efectuar una comparaci\u00f3n formal de adhesi\u00f3n.<\/p><h3 class=\"p2\"><b>Conclusiones<\/b><\/h3><p class=\"p1\">Los m\u00e9todos actualmente empleados para cuantificar la adhesi\u00f3n de un parche transd\u00e9rmico presentan limitaciones, pero resultan adecuados y confiables desde lo pr\u00e1ctico. Particularmente, el m\u00e9todo que emplea relaci\u00f3n de pesos, aunque m\u00e1s laborioso, sugiere ser m\u00e1s preciso que el que emplea cuadr\u00edcula para aplicar en un ensayo cl\u00ednico pivote que eval\u00fae la adhesi\u00f3n de un parche transdermal. La elecci\u00f3n de uno u otro m\u00e9todo depender\u00e1 principalmente del contexto regulatorio donde se realiza el ensayo formal.<\/p><p class=\"p1\">La evaluaci\u00f3n de adhesi\u00f3n de un parche transd\u00e9rmico puede resultar una tarea relativamente sencilla si los parches tienen cubierta transparente o trasl\u00facida, pero aumenta en complejidad para los parches con cubierta opaca.<\/p><p class=\"p1\">El empleo de fotograf\u00edas y su procesamiento, como herramienta para cuantificar adhesi\u00f3n de parches transd\u00e9rmicos, contin\u00faa siendo motivo de discusi\u00f3n en foros cient\u00edficos y agencias regulatorias, y est\u00e1 principalmente orientada a la estandarizaci\u00f3n las condiciones experimentales de medici\u00f3n: distancia al objeto, resoluci\u00f3n, luminosidad, protecci\u00f3n contra fraudes, validaci\u00f3n de la t\u00e9cnica, limitaciones por el dise\u00f1o del producto, entre otros.<\/p><p>\u00a0<\/p><p class=\"p2\"><b>Referencias<\/b><\/p><ol class=\"ol1\"><li class=\"li2\">Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs. Guidance for Industry, Draft, CDER\/FDA, Oct 2018<\/li><li class=\"li2\">Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms, EMA\/CHMP\/EWP\/280\/96 Rev1, 20-Nov-14<\/li><li class=\"li2\">Public Consultation No. 760, 27-Dic-2019, ANVISA, Brazil<\/li><li class=\"li2\"><a href=\"https:\/\/www.agah.eu\/wp-content\/uploads\/Schriever_patch_adhesion_local_tolerability.pdf\"><span class=\"s1\">https:\/\/www.agah.eu\/wp-content\/uploads\/Schriever_patch_adhesion_local_tolerability.pdf<\/span><\/a><\/li><li class=\"li4\"><span class=\"s2\"><a href=\"https:\/\/www.sas.com\/content\/dam\/SAS\/support\/en\/sas-global-forum-proceedings\/2020\/4655-2020.pdf\"><span class=\"s3\">https:\/\/www.sas.com\/content\/dam\/SAS\/support\/en\/sas-global-forum-proceedings\/2020\/4655-2020.pdf<\/span><\/a><\/span><\/li><\/ol><p 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elementor-size-default\">\u00a1As\u00f3ciese con nosotros!<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cabcea0 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"cabcea0\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Ofrecemos experiencia y \u201cknow how\u201d; y al mismo tiempo, flexibilidad y adaptabilidad a los requerimientos de nuestros clientes.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc7fbe4 elementor-align-left elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"cc7fbe4\" data-element_type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"mailto:info@amarintech.com.ar\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-envelope\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">info@amarintech.com.ar<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"tel:+54%2011%204588-6500\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-phone-alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">+54 11 4588-6500<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-map-marker-alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Sanchez 2045 (C1416BQG), Buenos Aires, Argentina.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3870875 elementor-widget elementor-widget-elementskit-social-media\" data-id=\"3870875\" data-element_type=\"widget\" data-widget_type=\"elementskit-social-media.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"ekit-wid-con\" >\t\t\t <ul class=\"ekit_social_media\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li class=\"elementor-repeater-item-69d37a6\">\n\t\t\t\t\t    <a\n\t\t\t\t\t\thref=\"https:\/\/www.linkedin.com\/company\/amarin-technologies-s-a-\/\" aria-label=\"LinkedIn\" class=\"linkedin\" 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prospecto.<\/p>","protected":false},"author":6,"featured_media":5869,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,22],"tags":[],"class_list":["post-8701","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-challenges","category-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.8.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Evaluation of the Adhesion of a Transdermal Patch: Pros &amp; Cons of Proposed Methods<\/title>\n<meta name=\"description\" content=\"The correct adhesion of a transdermal patch to skin throughout the established time of use is key to guarantee the effective administration of the dose declared in the prescribing information.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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