{"id":9587,"date":"2023-09-07T17:19:49","date_gmt":"2023-09-07T17:19:49","guid":{"rendered":"https:\/\/amarintech.com\/?p=9587"},"modified":"2023-09-07T18:47:03","modified_gmt":"2023-09-07T18:47:03","slug":"how-do-we-control-the-quality-of-transdermal-patches","status":"publish","type":"post","link":"https:\/\/amarintech.com\/es\/how-do-we-control-the-quality-of-transdermal-patches\/","title":{"rendered":"\u00bfComo controlamos la calidad de parches transdermales?"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9587\" class=\"elementor elementor-9587\">\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\" data-element_type=\"section\" 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class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-387f22c\" data-id=\"387f22c\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-inner-section elementor-element elementor-element-b3b76c9 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"b3b76c9\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-aed56c4\" data-id=\"aed56c4\" 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-22fcc07 elementor-widget elementor-widget-image\" data-id=\"22fcc07\" 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\t<a href=\"https:\/\/amarintech.com\/es\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"2000\" height=\"638\" src=\"https:\/\/amarintech.com\/wp-content\/uploads\/2023\/11\/Amarin-Listado-de-Productos.pdf\" class=\"attachment-full size-full wp-image-5849\" alt=\"\" sizes=\"(max-width: 2000px) 100vw, 2000px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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-442b119\" data-id=\"442b119\" 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d=\"M473,67.3c-203.9,88.3-263.1-34-320.3,0C66,119.1,0,59.7,0,59.7V0h1000v59.7 c0,0-62.1,26.1-94.9,29.3c-32.8,3.3-62.8-12.3-75.8-22.1C806,49.6,745.3,8.7,694.9,4.7S492.4,59,473,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" opacity=\"0.66\" d=\"M734,67.3c-45.5,0-77.2-23.2-129.1-39.1c-28.6-8.7-150.3-10.1-254,39.1 s-91.7-34.4-149.2,0C115.7,118.3,0,39.8,0,39.8V0h1000v36.5c0,0-28.2-18.5-92.1-18.5C810.2,18.1,775.7,67.3,734,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" 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-50 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\">\u00bfComo controlamos la calidad de parches transdermales?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b0c101 elementor-widget elementor-widget-text-editor\" data-id=\"1b0c101\" 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><strong>Florencia Cafisi<\/strong>- Jefa de Desarrollo Anal\u00edtico<\/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-50 elementor-top-column elementor-element elementor-element-c9ded8a\" data-id=\"c9ded8a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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-44be759 elementor-widget elementor-widget-text-editor\" data-id=\"44be759\" 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>Los parches transdermales presentan ciertos atributos que hacen a la eficacia, seguridad y calidad del medicamento y deben controlarse en el laboratorio mediante t\u00e9cnicas anal\u00edticas para asegurar el desempe\u00f1o y la inocuidad del Sistema de Administraci\u00f3n Transdermal (SAT, o, sus siglas en ingl\u00e9s TDS, \u201cTransdermal Delivery System\u201d). Alguno de estos m\u00e9todos anal\u00edticos corresponden a ensayos que son comunes a otras formas farmac\u00e9uticas. Sin embargo, dada las particularidades de los parches transdermales, existen procedimientos espec\u00edficos que se aplican a SATs y que se encuentran descriptos en regulaciones y farmacopeas internacionalmente reconocidas.<\/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-370a27b elementor-widget elementor-widget-text-editor\" data-id=\"370a27b\" 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>Marco regulatorio<\/h4><p>Debido al creciente el uso de parches transdermales para el tratamiento de ciertas patolog\u00edas y las ventajas que esta v\u00eda de administraci\u00f3n ofrece en cuanto al cumplimiento del tratamiento por parte del paciente y a la ausencia de efectos secundarios caracter\u00edstico por ejemplo, de formas orales; las Farmacopeas y regulaciones internacionales han mostrado inter\u00e9s en definir aquellos atributos cr\u00edticos que deben considerarse para el control de calidad de los parches transdermales.<\/p><p>La USP posee una secci\u00f3n exclusiva para el Control de productos t\u00f3picos y transdermales ( USP), adem\u00e1s de tener codificados algunos parches como por ejemplo de Rotigotina, Clonidina, Estradiol y Nicotina. En la Nota Generales 07. Formas de Dosificaci\u00f3n de la Farmacopea Europea, tambi\u00e9n se hace referencia a los parches.<\/p><p>Adem\u00e1s, existen gu\u00edas de FDA y EMA y, a nivel regional la gu\u00eda de ANVISA N\u00b020\/2019, que tambi\u00e9n incluyen  al desarrollo de esas formas farmac\u00e9uticas y definen consideraciones a tener en cuenta para el registro sanitario de estos productos.<\/p><p>Amarin Technologies se especializa en el desarrollo y la producci\u00f3n de sistemas de administraci\u00f3n transdermal tipo matriz, donde la droga se encuentra disuelta en la matriz adhesiva y cuenta con laboratorio de Desarrollo y de Control de Calidad especialmente equipados y con personal calificado y entrenado para este tipo de an\u00e1lisis.<\/p><p>\u00a0<\/p><h4>Ensayos Universales de Control de Calidad\u00a0<\/h4><p>La gu\u00eda ICH Q6A define los lineamientos generales para las Especificaciones de Nuevos F\u00e1rmacos y Medicamentos, incluyendo los siguientes atributos de calidad generales (que aplican a todas las formas farmac\u00e9uticas):<\/p><ul><li>\u2022\tDescripci\u00f3n: el aspecto del parche debe describirse indicando cualitativamente los diferentes componentes (matriz adhesiva, l\u00e1mina de despegue, l\u00e1mina de soporte, capa cobertura, l\u00e1mina de separaci\u00f3n), evaluando el comportamiento del parche al ser retirado del sobre, el desprendimiento de la l\u00e1mina de despegue, las caracter\u00edsticas de la impresi\u00f3n en la l\u00e1mina de soporte, su forma, color y opalescencia de la matriz, etc. \u00a0<\/li><li>\u2022\tIdentificaci\u00f3n: debe quedar inequ\u00edvocamente identificado el\/los principio\/s activo\/s mediante m\u00e9todos espec\u00edficos y de sencilla implementaci\u00f3n utilizando est\u00e1ndares de referencia con fines comparativos.<\/li><li>\u2022\tValoraci\u00f3n: para cuantificar el contenido de principio activo en los parches la droga debe ser extra\u00edda de la matriz y disuelta en un solvente apropiado, para luego cuantificarla mediante t\u00e9cnicas separativas apropiadas (cromatogr\u00e1ficas, espectrofotom\u00e9tricas, etc), evitando la interferencia de componentes de la matriz, productos de degradaci\u00f3n, reactivos, etc.<\/li><li>\u2022\tImpurezas: Al igual que otras formas farmac\u00e9uticas, debe asegurarse la pureza y seguridad del parche, analizando aquellas impurezas que pueden generarse en el proceso de manufactura o a lo largo de la vida \u00fatil del parche. Adem\u00e1s de las impurezas org\u00e1nicas consideradas sustancias relacionadas, para cumplir los requerimientos regulatorios espec\u00edficos, durante la instancia de desarrollo deben aplicarse herramientas de an\u00e1lisis de riesgo para definir, si corresponde, la estrategia de control de mon\u00f3meros, solventes residuales, impurezas elementales, lixiviados, nitrosaminas, etc.<\/li><\/ul><p>\u00a0<\/p><h4>Ensayos espec\u00edficos para controlar la Calidad de Parches Transdermales<\/h4><ul><li>\u2022\tUniformidad de unidad de dosis: cada parche representa una unidad de dosis y, al igual que en otras formas farmac\u00e9uticas, debe garantizarse la homogeneidad del lote valorando individualmente los parches y evaluando la variabilidad del proceso y la proximidad del contenido real al valor declarado del producto ( USP o 2.9.40. EP).<\/li><li>\u2022\tControl microbiol\u00f3gico: los parches transdermales son formas farmac\u00e9uticas no est\u00e9riles, por lo tanto, requieren an\u00e1lisis de recuentos de microrganismos ( USP o 2.6.12 EP) e investigaci\u00f3n de pat\u00f3genos que pudieran estar presentes en parches ( USP o 2.6.13 EP)<\/li><li>\u2022\tContenido de excipientes funcionales: pueden existir algunos excipientes funcionales en la formulaci\u00f3n cuyo contenido debe ser controlado, como por ejemplo enhancer o incrementadores de permeaci\u00f3n o antioxidantes que evitan la degradaci\u00f3n qu\u00edmica del f\u00e1rmaco.  Son ensayos dependientes de la f\u00f3rmula del producto.<\/li><li>\u2022\tCristales: cuando el ingrediente activo se encuentra disuelto en la matriz adhesiva, se requiere asegurar la ausencia de formaci\u00f3n de cristales durante su vida \u00fatil;  ya que, adem\u00e1s de afectar negativamente el aspecto del parche, reduce la cantidad de droga disuelta en la matriz disponible para ser liberada y absorbida a trav\u00e9s de la piel. Este ensayo puede realizarse a simple vista o tambi\u00e9n puede incluir el uso de instrumentos como ser lupas o microscopio.<\/li><li>\u2022\tDisoluci\u00f3n: Dado que s\u00f3lo una peque\u00f1a parte del contenido de f\u00e1rmaco del parche se libera o absorbe por el paciente, la liberaci\u00f3n in vitro tiene un valor limitado para la predicci\u00f3n del comportamiento in vivo del parche; pr\u00e1cticamente no es posible una correlaci\u00f3n in vitro\u2010in vivo en parches. Sin embargo, las farmacopeas describen dispositivos especialmente dise\u00f1ados para el control de parches transd\u00e9rmicos ( USP o 2.9.4. EP) y esta prueba se utiliza como herramienta de desarrollo y tambi\u00e9n es importante para garantizar la homogeneidad del lote.<\/li><li>\u2022\tPeso promedio y dimensiones: el control de gramaje de matriz y dimensiones hace a la dosis del medicamento y es un simple control que se lleva adelante en el laboratorio.<\/li><li>\u2022\tHermeticidad: Permite garantizar la integridad del envase durante la manufactura y a lo largo de la vida \u00fatil del producto.<\/li><li>\u2022\tPropiedades adhesivas: Los parches transdermales est\u00e1n formulados con una capa adhesiva para garantizar un contacto \u00edntimo con la piel y permitir la administraci\u00f3n de la dosis deseada del f\u00e1rmaco. Los adhesivos en TDS deben permitir una f\u00e1cil remoci\u00f3n del revestimiento antiadherente antes de su uso, adherirse adecuadamente a la piel humana despu\u00e9s de la aplicaci\u00f3n, mantener la adhesi\u00f3n a la piel durante el per\u00edodo de uso prescrito y permitir una f\u00e1cil remoci\u00f3n del TDS al final del uso sin dejar residuos. o causando da\u00f1o a la piel u otro(s) efecto(s) indeseable(s). La determinaci\u00f3n de propiedades adhesivas in vitro (fuerza adhesiva, fuerza de despegue, cohesividad, tack, flujo fr\u00edo; todas ellas descriptas descriptos en  USP) es un ensayo de control de calidad que permiten evaluar la reproducibilidad lote a lote y el comportamiento adhesivo en un sustrato bajo condiciones operativas estandarizadas.<\/li><\/ul><p>\u00a0<\/p><h4>El rol de los Laboratorios<\/h4><p>La correcta definici\u00f3n de los atributos cr\u00edticos de calidad (en ingl\u00e9s, \u201cCritical Quality Attribute\u201d o sus siglas CQA) de los parches transdermales durante la instancia de desarrollo, hace posible la implementaci\u00f3n de una estrategia de control acertada para garantizar la eficacia y seguridad de esta forma farmac\u00e9utica, asegurando que dichos par\u00e1metros se mantengan durante la vida \u00fatil del producto. Los Laboratorios de Amarin Technologies cuenta con los recursos y la experiencia que permiten llevar a cabo dichos controles de forma efectiva y bajo cumplimiento de las Buenas Pr\u00e1cticas de Manufactura.<\/p><p>\u00a0<\/p><p>\u00a0<\/p><p>Referencias:<\/p><p>&#8211; <a href=\"https:\/\/www.fda.gov\/media\/132674\/download\">FDA Transdermal and Topical Delivery Systems &#8211; Product Development and Quality Considerations Guidance for Industry<\/a> DRAFT GUIDANCE November 2019 Pharmaceutical Quality\/CMC<\/p><p>&#8211; <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-quality-transdermal-patches_en.pdf\">EMA Guideline on quality of transdermal patches<\/a> 23 October 2014 EMA\/CHMP\/QWP\/608924\/2014 Committee for Medicinal Products for Human Use (CHMP)<\/p><p>&#8211; \u00a0<a href=\"http:\/\/antigo.anvisa.gov.br\/documents\/10181\/5516542\/Guia+t%C3%B3picos+e+transd%C3%A9rmicos+14+-+adequado+ao+novo+modelo+12.02.2021.pdf\/38d9f16b-57ab-4ff5-a29c-4639c05e51da\">Guia n. 20 Guia sobre Requisitos de Qualidade para o Registro de Produtos T\u00f3picos e Transd\u00e9rmicos. Guia n\u00ba 20\/2019 \u2013 vers\u00e3o 2\u00a0<\/a><\/p><p>&#8211; USP\/NF 2023 y European Pharmacopeia 11.3.<\/p><p>&#8211; <a href=\"https:\/\/database.ich.org\/sites\/default\/files\/Q6A%20Guideline.pdf\">ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances<\/a>, October 1999<\/p><p>&#8211; <a href=\"https:\/\/database.ich.org\/sites\/default\/files\/Q8%28R2%29%20Guideline.pdf\">Q8(R2) Pharmaceutical Development<\/a>, August 2009<\/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-1780379 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1780379\" 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-inner-column elementor-element elementor-element-d257fda\" data-id=\"d257fda\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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\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-5a9c0c8a elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"5a9c0c8a\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\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-top-column elementor-element elementor-element-3cd2d944\" data-id=\"3cd2d944\" 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-90af84d elementor-widget elementor-widget-heading\" data-id=\"90af84d\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Suscribite a <br>#AmarinNews<\/h2>\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-top-column elementor-element elementor-element-1bd8c0a\" data-id=\"1bd8c0a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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-ea25cb4 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"ea25cb4\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-24a9a85\" data-id=\"24a9a85\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-c5e1f01 elementor-widget elementor-widget-menu-anchor\" data-id=\"c5e1f01\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"contactforn\"><\/div>\n\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-408b4f4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"408b4f4\" 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-66c23bc\" data-id=\"66c23bc\" 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-aa37af1 elementor-widget elementor-widget-heading\" data-id=\"aa37af1\" 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\">\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\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-556486e\" data-id=\"556486e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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\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-b8751dc elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"b8751dc\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-2d4bb11\" data-id=\"2d4bb11\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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-9eb582d elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"9eb582d\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a96dec3\" data-id=\"a96dec3\" 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-aebc9b3 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"aebc9b3\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\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-11b4142 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"11b4142\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-0dfdbb6\" data-id=\"0dfdbb6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-46f306b\" data-id=\"46f306b\" data-element_type=\"column\">\n\t\t\t<div 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elementor-social-icon-twitter elementor-repeater-item-eb443bf\" href=\"https:\/\/twitter.com\/AmarinTech\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-screen-only\">Twitter<\/span>\n\t\t\t\t\t\t<i class=\"fab fa-twitter\"><\/i>\t\t\t\t\t<\/a>\n\t\t\t\t<\/span>\n\t\t\t\t\t\t\t<span class=\"elementor-grid-item\">\n\t\t\t\t\t<a class=\"elementor-icon elementor-social-icon elementor-social-icon-linkedin elementor-repeater-item-621aaf0\" href=\"https:\/\/www.linkedin.com\/company\/amarin-technologies-s-a-\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-screen-only\">Linkedin<\/span>\n\t\t\t\t\t\t<i class=\"fab fa-linkedin\"><\/i>\t\t\t\t\t<\/a>\n\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\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-33 elementor-inner-column elementor-element elementor-element-f61dd4d\" data-id=\"f61dd4d\" 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-8155b95 elementor-widget elementor-widget-heading\" data-id=\"8155b95\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Explore<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c55c47 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"4c55c47\" 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=\"https:\/\/amarintech.com\/es\/about-us\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Nosotros<\/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=\"https:\/\/amarintech.com\/es\/technology\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Tecnolog\u00eda<\/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=\"https:\/\/amarintech.com\/es\/services-products\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Servicios y productos<\/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=\"https:\/\/amarintech.com\/es\/blog\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Blog<\/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<\/ul>\n\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-inner-section elementor-element elementor-element-d24a003 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"d24a003\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a1925e7\" data-id=\"a1925e7\" 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-afb4c3b elementor-widget elementor-widget-heading\" data-id=\"afb4c3b\" 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<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.cuervoestudio.com.ar\/\">Copyright \u00a92021 Amarin Technologies \nTodos los derechos reservados - Desarrollo by <u>Cuervo estudio<\/u><\/a><\/h2>\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-3ebecc6\" data-id=\"3ebecc6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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\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-4a2520d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4a2520d\" 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-73a603a\" data-id=\"73a603a\" 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-adb5839 elementor-widget elementor-widget-image\" data-id=\"adb5839\" 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\" src=\"https:\/\/amarintech.com\/wp-content\/plugins\/elementor\/assets\/images\/placeholder.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\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>","protected":false},"excerpt":{"rendered":"<p>Los parches transdermales presentan ciertos atributos que hacen a la eficacia, seguridad y calidad del medicamento y deben controlarse en el laboratorio mediante t\u00e9cnicas anal\u00edticas para asegurar el desempe\u00f1o y la inocuidad del Sistema de Administraci\u00f3n Transdermal (SAT, o, sus siglas en ingl\u00e9s TDS, \u201cTransdermal Delivery System\u201d). Alguno de estos m\u00e9todos anal\u00edticos corresponden a ensayos que son comunes a otras formas farmac\u00e9uticas. Sin embargo, dada las particularidades de los parches transdermales, existen procedimientos espec\u00edficos que se aplican a SATs y que se encuentran descriptos en regulaciones y farmacopeas internacionalmente reconocidas.<\/p>","protected":false},"author":6,"featured_media":9589,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21,36],"tags":[],"class_list":["post-9587","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-and-society","category-transdermal-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Transdermal patches present certain attributes that make the efficacy, safety, and quality of the product and must be controlled in the laboratory through analytical techniques to ensure the performance and safety of the transdermal delivery system (or TDS). Some of them correspond to tests that are common to other pharmaceutical forms. However, due to the particular characteristics of transdermal patches, there are specific procedures that apply to TDSs and that are described in internationally recognized regulations and pharmacopoeias.<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/amarintech.com\/es\/how-do-we-control-the-quality-of-transdermal-patches\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Studies for Generic Patches\" \/>\n<meta property=\"og:description\" content=\"The kind and quantity of clinical studies required for the submission of a regulatory application for a generic patch are different than those required for other pharmaceutical forms. 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