{"id":20927,"date":"2025-06-18T10:48:22","date_gmt":"2025-06-18T08:48:22","guid":{"rendered":"https:\/\/kymos.com\/news\/assaig-de-dissolucio-que-es-com-el-fem-i-per-que-es-important\/"},"modified":"2025-10-02T14:07:07","modified_gmt":"2025-10-02T12:07:07","slug":"assaig-de-dissolucio","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/assaig-de-dissolucio\/","title":{"rendered":"Assaig de dissoluci\u00f3: qu\u00e8 \u00e9s, com el fem i per qu\u00e8 \u00e9s important"},"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;\">Dissolution testing is a fundamental analytical technique in the pharmaceutical industry, providing <strong>information on how a drug is released from its dosage form<\/strong>. This analysis is vital for ensuring <strong>product quality<\/strong>, <strong>predicting performance<\/strong> <em>in vivo<\/em>, and meeting <strong>regulatory requirements<\/strong>.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">At Kymos Group, we are experts and count with years of experience in dissolution testing, offering a comprehensive suite of services that includes <strong>both compendial methods and tailored solutions<\/strong> for more complex drug delivery systems like transdermal patches. In this article, we&#8217;ll explore the various dissolution apparatus described in international pharmacopoeias and detail how we leverage our expertise and state-of-the-art equipment to support your pharmaceutical development needs.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>What is Dissolution Testing and Why is it Essential?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>Dissolution testing measures the rate and extent to which an active pharmaceutical ingredient (API) is released from a solid or semi-solid dosage form into a dissolution medium under controlled conditions<\/strong>. This process is critical for:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Quality Control (QC):<\/strong> Ensuring batch-to-batch consistency and verifying that products meet release specifications.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Formulation Development:<\/strong> Guiding the development of new drug products and optimizing their release profiles.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Bioequivalence (BE) Studies:<\/strong> Comparing the <em>in vitro<\/em> release characteristics of generic and reference drug products to predict <em>in vivo<\/em> equivalence.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Regulatory Submissions:<\/strong> Providing essential data for drug registration and approval.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">The choice of dissolution apparatus, medium, and stirring rate is critical and depends on the specific dosage form, its solubility, and its intended release characteristics.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Compendial Apparatus: Types and Applications<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">The <strong>United States Pharmacopeia (USP)<\/strong> and <strong>European Pharmacopoeia (Ph. Eur.)<\/strong>\u00a0describe seven dissolution test apparatus. Each is suited to specific dosage forms, following this table:<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Apparatus<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Included in USP &lt;711&gt;?<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Included in Ph. Eur.?<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Common Use Cases<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Notes<\/strong><\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><strong>Equipment at Kymos Group<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Apparatus 1<\/strong> (Basket)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Capsules, tablets prone to floating<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Rotating basket holds dosage<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Hanson Vision\u00ae G2 Elite 8\u2122 &amp; Agilent 708-DS<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Apparatus 2<\/strong> (Paddle)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Standard tablets, capsules<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Most common method<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Hanson Vision\u00ae G2 Elite 8\u2122 &amp; Agilent 708-DS<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Apparatus 3<\/strong> (Reciprocating Cylinder)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Extended-release dosage forms<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Simulates GI tract transitions<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c <em>Not currently offered<\/em><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Apparatus 4<\/strong> (Flow-Through Cell)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Poorly soluble drugs, modified release, suspensions<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Useful for complex or low-solubility APIs<\/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>Apparatus 5<\/strong> (Paddle over Disk)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c Not in Ph. Eur.<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Transdermal patches<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Disk holds patch under paddle<\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><em>Not standard; custom alternatives available<\/em><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Apparatus 6<\/strong> (Cylinder)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c Not in Ph. Eur.<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Transdermal delivery<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Uses rotating cylinder<\/span><\/td>\n<td><span style=\"font-size: 14pt;\"><em>Not standard; custom alternatives available<\/em><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 14pt;\"><strong>Apparatus 7<\/strong> (Reciprocating Holder)<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u2705 Yes<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c Not in Ph. Eur.<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Extended-release, implants<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">Vertical reciprocating system<\/span><\/td>\n<td><span style=\"font-size: 14pt;\">\u274c <em>Not currently offered<\/em><\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><\/h2>\n<h2><span style=\"font-size: 18pt;\"><strong>Compendial Methods: USP Apparatus 1, 2, and 4<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">At Kymos Group, our laboratories are equipped to perform compendial dissolution tests according to <strong>USP<\/strong>, <strong>Ph. Eur.<\/strong>, and other harmonized standards. We currently offer:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Apparatus 1 (Basket):<\/strong> For capsules and tablets, particularly those that tend to float.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Apparatus 2 (Paddle):<\/strong> The most widely used method, suitable for standard immediate- and modified-release oral dosage forms.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Apparatus 4 (Flow-Through Cell):<\/strong> Recommended for poorly soluble APIs and complex formulations like extended-release tablets and soft gels.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Each method is supported by validated procedures, controlled environments, and automated systems to ensure consistent, compliant results.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Our laboratories are equipped with state-of-the-art <strong>Hanson Vision\u00ae G2 Elite 8\u2122<\/strong> dissolution testers and <strong>Vision G2\/CD AutoPlus &amp; Autofill<\/strong> to cover the <strong>USP Apparatus 1 and 2<\/strong>, offering automated and high-throughput dissolution testing. In addition, we are equipped with <strong>Agilent 708-DS<\/strong> dissolution systems for these methods, providing added flexibility and capacity. For <strong>USP Apparatus 4<\/strong>, we utilize the <strong>SOTAX\u00ae CE 7smart<\/strong> to address testing of complex or low-solubility APIs.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Custom Method Development for Complex Dosage Forms <\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">In addition to standard methods, <strong>we develop custom dissolution methods for non-compendial dosage forms<\/strong>. A key example is our work with transdermal patches, where we adapt USP Apparatus 2 using membranes or modified sample holders to mimic physiological conditions and prevent buoyancy. You can read more information on this topic in our past <a href=\"https:\/\/kymos.com\/ca\/news\/proves-transdermiques-analisi-i-control-de-qualitat-dels-pegats-transdermics\/\" data-wpel-link=\"internal\">article on the analysis and quality control of transdermal patches<\/a>, and our <a href=\"https:\/\/kymos.com\/ca\/serveis\/cmc-analisi-i-control-de-qualitat\/analisi-transdermic\/\" data-wpel-link=\"internal\">service page for transdermal testing<\/a>.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">While USP Apparatus 5\u20137 are officially described for certain applications such as transdermals or implants, they are not always accessible or appropriate. <strong>Our expertise lies in bridging this gap with tailored methods that meet both scientific and regulatory expectations.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">These adapted methods are fully validated and aligned with current guidelines for method development, reproducibility, and compliance with international standards.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Get in Touch<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Whether you are developing a new oral solid or require release profiling for a complex delivery system, our team is ready to help. Learn more about how Kymos can support your project with expert dissolution testing solutions.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Contact us<\/strong> to discuss your testing needs: <a href=\"https:\/\/kymos.com\/ca\/contacte\/\" data-wpel-link=\"internal\">https:\/\/kymos.com\/contact\/<\/a> <\/span><br \/>\n<span style=\"font-size: 14pt;\"><strong>Explore our analytical services<\/strong>: <a href=\"https:\/\/kymos.com\/ca\/serveis\/\" 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":20780,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[67],"class_list":["post-20927","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca","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>Proves de dissoluci\u00f3: m\u00e8todes, aparells i aplicacions<\/title>\n<meta name=\"description\" content=\"M\u00e9s informaci\u00f3 sobre l&#039;assaig de dissoluci\u00f3 i com Kymos Group cobreix els m\u00e8todes compendials i ofereix solucions a mida.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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