{"id":28315,"date":"2025-06-18T10:48:22","date_gmt":"2025-06-18T08:48:22","guid":{"rendered":"https:\/\/kymos.com\/news\/tests-de-dissolution-definition-methode-et-importance\/"},"modified":"2025-12-03T19:04:48","modified_gmt":"2025-12-03T18:04:48","slug":"tests-de-dissolution-definition-methode-et-importance","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/tests-de-dissolution-definition-methode-et-importance\/","title":{"rendered":"Tests de dissolution&nbsp;: d\u00e9finition, m\u00e9thode et importance"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\">Les tests de dissolution constituent une technique analytique fondamentale dans l&rsquo;industrie pharmaceutique, fournissant <strong>des informations sur la lib\u00e9ration d&rsquo;un m\u00e9dicament \u00e0 partir de sa forme gal\u00e9nique<\/strong> . Cette analyse est essentielle pour garantir <strong>la qualit\u00e9 du produit<\/strong> , <strong>pr\u00e9dire son efficacit\u00e9<\/strong> <em>in vivo<\/em> et satisfaire <strong>aux exigences r\u00e9glementaires<\/strong> . <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Chez Kymos Group, nous sommes experts en tests de dissolution et b\u00e9n\u00e9ficions d&rsquo;une longue exp\u00e9rience. Nous proposons une gamme compl\u00e8te de services, incluant <strong>les m\u00e9thodes pharmacop\u00e9iques et des solutions sur mesure<\/strong> pour les syst\u00e8mes d&rsquo;administration de m\u00e9dicaments plus complexes, tels que les patchs transdermiques. Cet article pr\u00e9sente les diff\u00e9rents appareils de dissolution d\u00e9crits dans les pharmacop\u00e9es internationales et explique comment nous mettons \u00e0 profit notre expertise et nos \u00e9quipements de pointe pour r\u00e9pondre \u00e0 vos besoins en mati\u00e8re de d\u00e9veloppement pharmaceutique. <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Qu\u2019est-ce qu\u2019un test de dissolution et pourquoi est-il essentiel&nbsp;?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>Les tests de dissolution mesurent la vitesse et l&rsquo;\u00e9tendue de la lib\u00e9ration d&rsquo;un principe actif pharmaceutique (API) \u00e0 partir d&rsquo;une forme posologique solide ou semi-solide dans un milieu de dissolution, dans des conditions contr\u00f4l\u00e9es<\/strong> . Ce proc\u00e9d\u00e9 est essentiel pour&nbsp;: <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Contr\u00f4le qualit\u00e9 (CQ) :<\/strong> Garantir la coh\u00e9rence d&rsquo;un lot \u00e0 l&rsquo;autre et v\u00e9rifier que les produits r\u00e9pondent aux sp\u00e9cifications de mise sur le march\u00e9.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>D\u00e9veloppement de formulations :<\/strong> Orienter le d\u00e9veloppement de nouveaux m\u00e9dicaments et optimiser leurs profils de lib\u00e9ration.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u00c9tudes de bio\u00e9quivalence (BE) :<\/strong> Comparaison des caract\u00e9ristiques de lib\u00e9ration <em>in vitro<\/em> des m\u00e9dicaments g\u00e9n\u00e9riques et de r\u00e9f\u00e9rence pour pr\u00e9dire l&rsquo;\u00e9quivalence <em>in vivo<\/em> .<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Soumissions r\u00e9glementaires :<\/strong> Fourniture des donn\u00e9es essentielles pour l&rsquo;enregistrement et l&rsquo;approbation des m\u00e9dicaments.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Le choix de l&rsquo;appareil de dissolution, du milieu et de la vitesse d&rsquo;agitation est crucial et d\u00e9pend de la forme posologique sp\u00e9cifique, de sa solubilit\u00e9 et de ses caract\u00e9ristiques de lib\u00e9ration pr\u00e9vues.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Appareils de compilation&nbsp;: types et applications<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">La <strong>Pharmacop\u00e9e des \u00c9tats-Unis (USP)<\/strong> et <strong>la Pharmacop\u00e9e europ\u00e9enne (Ph. Eur.)<\/strong> d\u00e9crivent sept appareils de test de dissolution. Chacun est adapt\u00e9 \u00e0 des formes posologiques sp\u00e9cifiques, comme indiqu\u00e9 dans le tableau ci-dessous&nbsp;: <\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Inclus dans l&rsquo;USP&lt; 711&gt; ?<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Inclus dans la Ph. Eur. ?<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Cas d&rsquo;utilisation courants<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Notes<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>\u00c9quipement chez Kymos Group<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil 1<\/strong> (Panier)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">G\u00e9lules et comprim\u00e9s susceptibles de flotter<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Le panier rotatif contient la dose<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Hanson Vision\u00ae G2 Elite 8\u2122 et Agilent 708-DS<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil 2<\/strong> (Pagaie)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Comprim\u00e9s et g\u00e9lules standards<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">m\u00e9thode la plus courante<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Hanson Vision\u00ae G2 Elite 8\u2122 et Agilent 708-DS<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil 3<\/strong> (Cylindre alternatif)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">formes posologiques \u00e0 lib\u00e9ration prolong\u00e9e<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Simule les transitions du tractus gastro-intestinal<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c <em>Non disponible actuellement<\/em><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil 4<\/strong> (Cellule \u00e0 flux continu)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">M\u00e9dicaments peu solubles, \u00e0 lib\u00e9ration modifi\u00e9e, en suspensions<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Utile pour les API complexes ou peu solubles<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">SOTAX\u00ae CE 7smart<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil 5<\/strong> (Pagaie sur disque)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c Non r\u00e9pertori\u00e9 dans la Ph. Eur.<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Patchs transdermiques<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Le disque maintient le patch sous la pagaie<\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><em>Non standard&nbsp;; des alternatives personnalis\u00e9es sont disponibles.<\/em><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil 6<\/strong> (Cylindre)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c Non r\u00e9pertori\u00e9 dans la Ph. Eur.<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Administration transdermique<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Utilise un cylindre rotatif<\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><em>Non standard&nbsp;; des alternatives personnalis\u00e9es sont disponibles.<\/em><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Appareil 7<\/strong> (Porte-pi\u00e8ce alternatif)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Oui<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c Non r\u00e9pertori\u00e9 dans la Ph. Eur.<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Implants \u00e0 lib\u00e9ration prolong\u00e9e<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Syst\u00e8me alternatif vertical<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c <em>Non disponible actuellement<\/em><\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><\/h2>\n<h2><span style=\"font-size: 18pt;\"><strong>M\u00e9thodes de la pharmacop\u00e9e&nbsp;: Appareils 1, 2 et 4 de l\u2019USP<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Au sein du Groupe Kymos, nos laboratoires sont \u00e9quip\u00e9s pour r\u00e9aliser des tests de dissolution conformes aux <strong>pharmacop\u00e9es USP<\/strong> , <strong>Ph. Eur.<\/strong> et autres normes harmonis\u00e9es. Nous proposons actuellement&nbsp;: <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Appareil 1 (Panier) :<\/strong> Pour les capsules et les comprim\u00e9s, en particulier ceux qui ont tendance \u00e0 flotter.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Appareil 2 (Pagaie) :<\/strong> La m\u00e9thode la plus couramment utilis\u00e9e, adapt\u00e9e aux formes posologiques orales standard \u00e0 lib\u00e9ration imm\u00e9diate et modifi\u00e9e.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Appareil 4 (Cellule \u00e0 flux continu) :<\/strong> Recommand\u00e9 pour les API peu solubles et les formulations complexes comme les comprim\u00e9s \u00e0 lib\u00e9ration prolong\u00e9e et les g\u00e9lules molles.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Chaque m\u00e9thode s&rsquo;appuie sur des proc\u00e9dures valid\u00e9es, des environnements contr\u00f4l\u00e9s et des syst\u00e8mes automatis\u00e9s afin de garantir des r\u00e9sultats coh\u00e9rents et conformes.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Nos laboratoires sont \u00e9quip\u00e9s d&rsquo;appareils de dissolution <strong>Hanson Vision\u00ae G2 Elite 8\u2122<\/strong> et <strong>Vision G2\/CD AutoPlus &amp; Autofill<\/strong> de pointe, conformes aux <strong>appareils 1 et 2 de l&rsquo;USP<\/strong> , permettant des tests de dissolution automatis\u00e9s \u00e0 haut d\u00e9bit. De plus, nous disposons de syst\u00e8mes de dissolution <strong>Agilent 708-DS<\/strong> pour ces m\u00e9thodes, offrant une flexibilit\u00e9 et une capacit\u00e9 accrues. Pour <strong>l&rsquo;appareil 4 de l&rsquo;USP<\/strong> , nous utilisons le <strong>SOTAX\u00ae CE 7smart<\/strong> afin de traiter les principes actifs pharmaceutiques (API) complexes ou peu solubles.  <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>D\u00e9veloppement de m\u00e9thodes personnalis\u00e9es pour les formes posologiques complexes  <\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Outre les m\u00e9thodes standard, <strong>nous d\u00e9veloppons des m\u00e9thodes de dissolution personnalis\u00e9es pour les formes gal\u00e9niques non pharmacop\u00e9iques<\/strong> . \u00c0 titre d&rsquo;exemple, nous adaptons l&rsquo;appareil&nbsp;2 de l&rsquo;USP \u00e0 l&rsquo;aide de membranes ou de porte-\u00e9chantillons modifi\u00e9s afin de reproduire les conditions physiologiques et d&#8217;emp\u00eacher la flottabilit\u00e9. Vous trouverez plus d&rsquo;informations \u00e0 ce sujet dans notre <a href=\"https:\/\/kymos.com\/fr\/news\/tests-transdermiques-analyse-et-controle-de-la-qualite-des-patchs-transdermiques\/\" data-wpel-link=\"internal\">article pr\u00e9c\u00e9dent sur l&rsquo;analyse et le contr\u00f4le qualit\u00e9 des patchs transdermiques<\/a> , ainsi que sur notre <a href=\"https:\/\/kymos.com\/fr\/services\/analyse-cmc-et-controle-qualite\/tests-transdermiques\/\" data-wpel-link=\"internal\">page d\u00e9di\u00e9e aux tests transdermiques<\/a> .  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Bien que les appareils USP 5 \u00e0 7 soient officiellement d\u00e9crits pour certaines applications telles que les transdermiques ou les implants, ils ne sont pas toujours accessibles ou appropri\u00e9s.  <strong>Notre expertise r\u00e9side dans notre capacit\u00e9 \u00e0 combler cet \u00e9cart gr\u00e2ce \u00e0 des m\u00e9thodes sur mesure qui r\u00e9pondent aux exigences scientifiques et r\u00e9glementaires.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Ces m\u00e9thodes adapt\u00e9es sont enti\u00e8rement valid\u00e9es et conformes aux directives actuelles en mati\u00e8re de d\u00e9veloppement de m\u00e9thodes, de reproductibilit\u00e9 et de conformit\u00e9 aux normes internationales.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Entrer en contact<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Que vous d\u00e9veloppiez un nouveau m\u00e9dicament oral solide ou que vous ayez besoin d&rsquo;\u00e9tablir le profil de lib\u00e9ration d&rsquo;un syst\u00e8me d&rsquo;administration complexe, notre \u00e9quipe est l\u00e0 pour vous accompagner. D\u00e9couvrez comment Kymos peut soutenir votre projet gr\u00e2ce \u00e0 ses solutions expertes en tests de dissolution. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Contactez-nous<\/strong> pour discuter de vos besoins en mati\u00e8re de tests&nbsp;: <a href=\"https:\/\/kymos.com\/fr\/contact\/\" data-wpel-link=\"internal\">https:\/\/kymos.com\/contact\/<\/a> <\/span><br \/>\n<span style=\"font-size: 14pt;\"><strong>D\u00e9couvrez nos services d&rsquo;analyse<\/strong>&nbsp;: <a href=\"https:\/\/kymos.com\/fr\/services\/\" data-wpel-link=\"internal\">https:\/\/kymos.com\/services\/<\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":28317,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[267],"tags":[67],"class_list":["post-28315","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tests de dissolution\u00a0: d\u00e9finition, m\u00e9thode et importance<\/title>\n<meta name=\"description\" content=\"Apprenez-en davantage sur les tests de dissolution et d\u00e9couvrez comment Kymos Group couvre les m\u00e9thodes pharmacop\u00e9iques et propose des solutions sur mesure.\" \/>\n<meta name=\"robots\" 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