{"id":8242,"date":"2023-11-23T10:11:56","date_gmt":"2023-11-23T09:11:56","guid":{"rendered":"https:\/\/www.iqac.csic.es\/el-servei-davaluacio-dermocosmetica-del-csic-obte-el-certificat-de-bones-practiques-de-laboratori-en-absorcio-percutania\/"},"modified":"2026-06-16T10:47:19","modified_gmt":"2026-06-16T08:47:19","slug":"el-servei-davaluacio-dermocosmetica-del-csic-obte-el-certificat-de-bones-practiques-de-laboratori-en-absorcio-percutania","status":"publish","type":"post","link":"https:\/\/www.iqac.csic.es\/ca\/el-servei-davaluacio-dermocosmetica-del-csic-obte-el-certificat-de-bones-practiques-de-laboratori-en-absorcio-percutania\/","title":{"rendered":"El Servei d&#8217;Avaluaci\u00f3 Dermocosm\u00e8tica del CSIC obt\u00e9 el certificat de Bones Pr\u00e0ctiques de Laboratori en absorci\u00f3 percut\u00e0nia"},"content":{"rendered":"<p>El <a href=\"https:\/\/www.iqac.csic.es\/ca\/serveis\/avaluacio-dermocosmetica\/\" target=\"_blank\" rel=\"noopener\"><strong>Servei d&#8217;Avaluaci\u00f3 Dermocosm\u00e8tica<\/strong><\/a> de l&#8217;<strong><a href=\"https:\/\/www.iqac.csic.es\/\">Institut de Qu\u00edmica Avan\u00e7ada de Catalunya<\/a> (IQAC)<\/strong> del <strong><a href=\"https:\/\/www.csic.es\/es\">Consell Superior d\u2019Investigacions Cient\u00edfiques<\/a> (CSIC)<\/strong> ha obtingut la certificaci\u00f3 de Bones Pr\u00e0ctiques de Laboratori (BPL) de l\u2019ENAC per a realitzar assajos d&#8217;absorci\u00f3 percut\u00e0nia de biocides.<\/p>\n<blockquote><p>\u201cL&#8217;avaluaci\u00f3 de l&#8217;absorci\u00f3 percut\u00e0nia o la permeaci\u00f3 cut\u00e0nia de mol\u00e8cules \u00e9s important per a molts productes, com els sistemes d&#8217;administraci\u00f3 d\u00e8rmica o transd\u00e8rmica (productes farmac\u00e8utics, cosm\u00e8tics), productes agroqu\u00edmics (pesticides, herbicides o fungicides), etc. i per al desenvolupament satisfactori de noves formulacions destinades a l&#8217;\u00fas hum\u00e0\u201d, explica la <strong>Dra. Luisa Coderch<\/strong>, investigadora de l\u2019IQAC i responsable del Servei d&#8217;Avaluaci\u00f3 Dermocosm\u00e8tica.<\/p><\/blockquote>\n<p>Aquest laboratori es converteix aix\u00ed en <strong>el primer d&#8217;Espanya, tant p\u00fablic com privat, que rep la certificaci\u00f3 BPL per a biocides i el primer laboratori p\u00fablic (el quart, si s&#8217;inclouen els privats) a rebre la certificaci\u00f3 per a f\u00e0rmacs i cosm\u00e8tics<\/strong>.<\/p>\n<p>Les certificacions inclouen tant la determinaci\u00f3 anal\u00edtica en f\u00e0rmacs i cosm\u00e8tics com en biocides. Els biocides s\u00f3n subst\u00e0ncies que s&#8217;usen per a controlar el creixement d&#8217;organismes nocius, com bacteris i fongs. En molts productes cosm\u00e8tics s&#8217;utilitzen com a conservants i alguns d&#8217;ells s\u00f3n importants al\u00b7lerg\u00f2gens.<\/p>\n<p>Les BPL s\u00f3n sistemes de qualitat dels processos i les condicions que han de complir-se en els estudis no cl\u00ednics de seguretat sanit\u00e0ria i mediambiental, que garanteixen que es compleixen unes normes de qualitat estrictes. Aquestes directrius garanteixen una estructura s\u00f2lida per a la ci\u00e8ncia m\u00e8dica i permeten obtenir dades de millor \u00a0qualitat, i uns estudis precisos i reprodu\u00efbles, assegurant que els resultats dels assajos siguin reconeguts pels altres pa\u00efsos membres de la Uni\u00f3 Europea (UE) i per l&#8217;Organitzaci\u00f3 per a la Cooperaci\u00f3 i el Desenvolupament Econ\u00f2mics (OCDE). Aquesta certificaci\u00f3, atorgada per l&#8217;Entitat Nacional d&#8217;Acreditaci\u00f3 (ENAC) \u00e9s imprescindible per a complir la regulaci\u00f3 exigida per a actius en contacte amb la pell.<\/p>\n<h6><strong>Funci\u00f3 barrera de la pell<\/strong><\/h6>\n<p>Una de les funcions de la pell \u00e9s la protecci\u00f3 enfront de l&#8217;entrada d&#8217;agents externs de naturalesa variada i evitar grans p\u00e8rdues d&#8217;humitat de la pell (sense la pell, els mam\u00edfers es deshidratarien r\u00e0pidament i moririen). \u00c9s una important barrera contra l&#8217;entrada de microorganismes i subst\u00e0ncies qu\u00edmiques. No obstant aix\u00f2, algunes subst\u00e0ncies poden penetrar la pell, si b\u00e9 la majoria d&#8217;elles ho fan d&#8217;una manera superficial com, per exemple, els cosm\u00e8tics. Algunes d&#8217;elles s\u00f3n capaces d&#8217;arribar a zones m\u00e9s profundes,\u00a0 quelcom en principi reservat nom\u00e9s per a f\u00e0rmacs. Aix\u00f2 \u00e9s precisament el que s&#8217;avalua en aquest servei, de quina forma penetra una subst\u00e0ncia en la pell i que la seva penetraci\u00f3 sigui la prevista d&#8217;acord amb el seu efecte esperat.<\/p>\n<p>L&#8217;avaluaci\u00f3 <em>in vivo<\/em> per a productes cosm\u00e8tics no est\u00e0 permesa en la Constituci\u00f3 Espanyola des de 2013, segons el Reglament 1223\/2009 de la UE sobre cosm\u00e8tics. Per a compostos cosm\u00e8tics i f\u00e0rmacs en les primeres fases d&#8217;avaluaci\u00f3 s&#8217;han desenvolupat models alternatius, com pell humana <em>ex vivo<\/em>, obtinguda normalment de pacients de cirurgia pl\u00e0stica, o pell i mucoses d&#8217;animal <em>ex vivo<\/em>. D&#8217;altra banda, el model d&#8217;absorci\u00f3 amb mucosa bucal animal s&#8217;ha convertit tamb\u00e9 en un model atractiu per als estudis d&#8217;administraci\u00f3 local i sist\u00e8mica de f\u00e0rmacs, servint les mucoses bucals com a model vaginal. Tamb\u00e9 s&#8217;han desenvolupat models de l\u00e0mines unguials bovines per a estudis sobre les ungles.<\/p>\n<h6><strong>Servei pioner a Espanya<\/strong><\/h6>\n<p>El Servei d&#8217;Avaluaci\u00f3 Dermocosm\u00e8tica, pioner en estudis d&#8217;absorci\u00f3 percut\u00e0nia, oferts des de 1998 i certificats ara per complet, dissenya i realitza aquests assajos de conformitat amb les directrius de l&#8217;Organitzaci\u00f3 per a la Cooperaci\u00f3 i el Desenvolupament Econ\u00f2mics (OCDE), l&#8217;Administraci\u00f3 d&#8217;Aliments i Medicaments (FDA) i l&#8217;Ag\u00e8ncia Europea de Medicaments (EMA).<\/p>\n<p>Aquests assajos de productes t\u00f2pics es divideixen en dos grups principals. D&#8217;una banda, els <strong>assajos d&#8217;alliberament <em>in vitro<\/em><\/strong>, en els quals s&#8217;utilitzen fonamentalment <strong>membranes artificials<\/strong> per\u00a0 determinar la quantitat i velocitat d&#8217;alliberament de f\u00e0rmacs, essencials en el desenvolupament de noves formulacions t\u00f2piques, control de qualitat, etc.<\/p>\n<p>D&#8217;altra banda, els <strong>assajos de permeaci\u00f3 <em>in vitro<\/em><\/strong>, en els quals es mesuren les quantitats absorbides transd\u00e8rmiques, la velocitat de flux i la distribuci\u00f3 per capes de la membrana. En aquesta opci\u00f3 es pot utilitzar <strong>mostres de pell o d&#8217;altres teixits<\/strong> amb diferents aplicacions t\u00f2piques.<\/p>\n<p>Aquests \u00faltims assajos estan basats en la separaci\u00f3 de les diferents capes de la pell per a mesurar la penetraci\u00f3 cut\u00e0nia en avaluacions de seguretat, fonamentalment de cosm\u00e8tics, f\u00e0rmacs i biocides.<\/p>\n<p>Els dos tipus de tests es dirigeixen a investigadors i fabricants de productes t\u00f2pics i gen\u00e8rics que necessiten caracteritzacions de formulaci\u00f3 d\u00e8rmica, seguretat cosm\u00e8tica o autoritzacions per a gen\u00e8rics t\u00f2pics mitjan\u00e7ant estudis de bioequival\u00e8ncia <em>in vitro.<\/em><\/p>\n<blockquote><p>\u201cLa realitzaci\u00f3 dels assajos descrits sota la certificaci\u00f3 \u00a0BPL \u00e9s imprescindible per a aconseguir els permisos de comercialitzaci\u00f3 de f\u00e0rmacs, cosm\u00e8tics i biocides de conformitat amb el marc regulador legal vigent\u201d, explica la <strong>Dra. Luisa Coderch<\/strong>. \u201cEl nostre Servei de Dermocosm\u00e8tica porta d\u00e8cades realitzant aquest tipus d&#8217;estudis, proporcionant les dades que ajuden a obtenir l&#8217;aprovaci\u00f3 reglament\u00e0ria per a productes agroqu\u00edmics, farmac\u00e8utics i de consum, i actualment \u00e9s l&#8217;\u00fanica entitat p\u00fablica que pot realitzar aquests assajos amb la garantia contrastada necess\u00e0ria en processos reguladors d&#8217;efic\u00e0cia i seguretat\u201d, conclou \u00a0<strong>Coderch<\/strong>.<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: right;\"><strong>IQAC-CSIC Comunicaci\u00f3<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El Servei d&#8217;Avaluaci\u00f3 Dermocosm\u00e8tica de l&#8217;Institut de Qu\u00edmica Avan\u00e7ada de Catalunya (IQAC) del Consell Superior d\u2019Investigacions Cient\u00edfiques (CSIC) ha obtingut la certificaci\u00f3 de Bones Pr\u00e0ctiques de Laboratori (BPL) de l\u2019ENAC per a realitzar assajos d&#8217;absorci\u00f3 percut\u00e0nia de biocides. \u201cL&#8217;avaluaci\u00f3 de l&#8217;absorci\u00f3 percut\u00e0nia o la permeaci\u00f3 cut\u00e0nia de mol\u00e8cules \u00e9s important per a molts productes, com<a class=\"more-link\" href=\"https:\/\/www.iqac.csic.es\/ca\/el-servei-davaluacio-dermocosmetica-del-csic-obte-el-certificat-de-bones-practiques-de-laboratori-en-absorcio-percutania\/\">Continue reading <span class=\"screen-reader-text\">\u00abEl Servei d&#8217;Avaluaci\u00f3 Dermocosm\u00e8tica del CSIC obt\u00e9 el certificat de Bones Pr\u00e0ctiques de Laboratori en absorci\u00f3 percut\u00e0nia\u00bb<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":4428,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[73],"tags":[],"class_list":["post-8242","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - 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