Orally Disintegrating Tablets

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et_pb_row_0"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_0 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_code et_pb_code_0"> <div class="et_pb_code_inner"><a name="top"></a></div> </div><div class="et_pb_module et_pb_dcsbcm_divi_breadcrumbs_module et_pb_dcsbcm_divi_breadcrumbs_module_0"> <div class="et_pb_module_inner"> <ol class="dcsbcm_divi_breadcrumbs" vocab="http://schema.org/" typeof="BreadcrumbList"><li class="dcsbcm_divi_breadcrumb" property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://www.catalent.com/"><span property="name">Home</span></a><meta property="position" content="1"></li><span class="dcsbcm_separator"> » </span><li class="dcsbcm_divi_breadcrumb" property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://www.catalent.com/oral-dose/"><span property="name">Oral Dose</span></a><meta property="position" content="3"></li><span class="dcsbcm_separator"> » </span><li class="dcsbcm_divi_breadcrumb" property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://www.catalent.com/oral-dose/oral-technologies/"><span property="name">Oral Technologies</span></a><meta property="position" content="2"></li><span class="dcsbcm_separator"> » </span><span class="dcsbcm_divi_breadcrumb dcsbcm_divi_breadcrumb-active">Orally Disintegrating Tablets</span></ol> </div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_1 et_section_regular" > <div class="et_pb_row et_pb_row_1"> <div class="et_pb_column et_pb_column_3_4 et_pb_column_1 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module mugo_catalent_title mugo_catalent_title_0"> <div class="et_pb_module_inner"> <div class="ctl-title"> <div class="title-image image-large"> <img decoding="async" src="https://www.catalent.com/wp-content/uploads/2019/06/zydis.png" aria-hidden="true" /> </div> <div class="title-content" style="color:#332a86 !important;"> <h1>Zydis® Fast Dissolve Technology Platform</h1> </div> </div> </div> </div><div class="et_pb_module et_pb_text et_pb_text_0 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">CATALENT’S BEST-IN-CLASS FAMILY OF FAST DISSOLVE TECHNOLOGIES</div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child et_pb_column_empty"> </div> </div> </div><div class="et_pb_section et_pb_section_2 et_section_specialty" > <div class="et_pb_row"> <div class="et_pb_column et_pb_column_3_4 et_pb_column_3 et_pb_specialty_column et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_row_inner et_pb_row_inner_0"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_0 et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>OVERVIEW</h4> <h5><a style="color: #000000;text-decoration: underline" href="#benefits">Customer Benefits</a>      <a style="color: #000000;text-decoration: underline" href="#differentiation">Valuable Product Differentiation</a>      <a style="color: #000000;text-decoration: underline" href="#how-it-works">How It Works</a>      <a style="color: #000000;text-decoration: underline" href="#zydis-ultra">Zydis® Ultra</a>      <a style="color: #000000;text-decoration: underline" href="#zydis-bio">Zydis® Bio</a>      <a style="color: #000000;text-decoration: underline" href="#how-its-made">How It Is Made</a>      <a style="color: #000000;text-decoration: underline" href="#capabilities">Catalent Capabilities</a>      <a style="color: #000000;text-decoration: underline" href="#services">Catalent Services</a>      <a style="color: #000000;text-decoration: underline" href="#facilities">Facilities</a></h5></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_0 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><img fetchpriority="high" decoding="async" src="https://www.catalent.com/wp-content/uploads/2019/06/05a-ZYDIS-S-Catalent-0282-v2.jpg" alt="" width="295" height="170" class="alignright size-full wp-image-213810">The Zydis® ODT (orally dissolving tablet) fast-dissolve formulation, is a unique, freeze-dried oral solid dosage form that disperses almost instantly in the mouth – no water required. With more than 20 products launched in 60 countries, it continues to be the world’s best-in-class ODT technology. Our Zydis® fast dissolve team is the best trained in the world, offering feasibility evaluations as well as support across the entire lifecycle of your product. Whether you are considering an ODT to enhance pharmacokinetics through pre-gastric absorption, looking for a way to improve patient compliance, or seeking a marketing advantage for a valued brand, Zydis® fast dissolve can help enhance the value of your investment and accelerate your product’s potential.</div> </div><div class="et_pb_module et_pb_divider et_pb_divider_1 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="benefits"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>CUSTOMER BENEFITS</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_4 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><ul style="padding-bottom: 0"> <li>Better pregastric absorption for certain drug compounds</li> <li>More efficient delivery</li> <li>Ideal for certain indications</li> <li>Protection from counterfeiting</li> <li>A wider range of application: <ul style="padding-bottom: 0"> <li>Dysphagia</li> <li>Pediatric and geriatric application</li> <li>Fast Onset</li> <li>Ease of use</li> </ul> </li> <li>A wide range of therapeutic areas <ul style="padding-bottom: 0"> <li>Anti-psychotic (Parkinson’s disease, schizophrenia)</li> <li>Anti-emetic (Travel sickness)</li> <li>Gastro (Diarrhea, Constipation)</li> <li>Allergy (Anti histamine, immunotherapy)</li> <li>Anxiolytic (Anti-depressants)</li> </ul> </li> </ul> <p><br class="”clearfix”" /><br />Case Study: Zydis® Fast Dissolve Technologies – <a href="https://www.catalent.com/expert-content/oral-technologies/zydis-odt-unlocks-a-patient-preference-for-rapid-onset-in-the-treatment-of-migraine/">Rapid Onset in the Treatment of Migraine</a></p></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_2 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_5 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="differentiation"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>VALUABLE PRODUCT DIFFERENTIATION</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_6 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><ul class="squareLi"> <li>High level of customer preference</li> <li>Enhanced market appeal</li> <li>Rapid onset of action</li> <li>Multiple colors and shapes</li> <li>Embossing with corporate logos and product codes</li> <li>Unique packaging, including child-resistant options</li> <li>Taste masking and flavors formulated for specific markets, including pediatrics and veterinary medicine</li> </ul></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_3 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_7 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="how-it-works"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>HOW IT WORKS</h4></div> </div><div class="et_pb_module et_pb_video"><lite-youtube videoid="IFxQ9P90jPA"><a class="lite-youtube-fallback" href="https://youtu.be/IFxQ9P90jPA">Watch on YouTube</a></lite-youtube></div><div class="et_pb_module et_pb_divider et_pb_divider_4 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="zydis-ultra"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>ZYDIS® ULTRA</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_9 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">Innovation in Progress:</p> <ul> <li>Same dissolution profile</li> <li>Greater taste masking capabilities</li> <li>Increased doses > 400mg</li> <li>Functional coating for controlled / sustained release applications</li> <li>High speed manufacturing</li> <li>On-line printing for flexible solutions</li> <li>Wider range of application</li> </ul> <p>Ideal for consumer health (OTC), and to mask bitter or strong tasting API</div> </div><div class="et_pb_module et_pb_divider et_pb_divider_5 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_10 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="zydis-bio"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>ZYDIS® BIO</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_11 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">The ability through class-leading Zydis® ODT technology to deliver fast dissolve formulations of large molecule allergens, viral vaccines, and peptides.</p> <p>The challenges of oral delivery of proteins & peptides well documented and are not limited to:</p> <ul> <li>pH</li> <li>Peptidase & proteolytic enzyme activity</li> <li>Potential interaction with other constituents of GI fluids</li> <li>High molecular weight</li> </ul> <p>Zydis® Bio sub-lingual delivery overcomes these challenges:</p> <ul> <li>Avoids harsh environment of GIT</li> <li>Use of bio-adhesives / absorption enhancers</li> <li>Pre-gastric delivery (e.g. buccal, sublingual, oesophageal)</li> <li>pH relatively neutral (5.5 – 7.2 depending on salivary flow rate)</li> </ul> <p>Benefits of Zydis® Bio for peptide & protein drugs</p> <ul> <li>Potential for sublingual / buccal absorption</li> <li>Solid, unit doses presented in protective pack</li> <li>Low temperature processing minimizes manufacturing losses of labile drugs</li> <li>Solution / suspension dosing achieves good content uniformity for low dose actives</li> <li>Solid dosage form and low water activity aids long term stability</li> <li>Liquid processing facilitates containment of potent drugs in production</li> </ul></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_6 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_12 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="how-its-made"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>HOW IT IS MADE</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_13 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><strong>Stage 1 – Mixing</strong><br /> The bulk API is formulated into a liquid solution or suspension.</p> <p><strong>Stage 2 – Filling and freezing</strong><br /> The liquid is precisely filled into pre-formed blisters and passed through a specially designed cryogenic freezing process to control the ultimate size of the ice crystals.</p> <p><strong>Stage 3 – Lyophilization</strong><br /> The frozen units are then transferred to large-scale freeze dryers for the lyophilization process.</p> <p><strong>Stage 4 – Sealing</strong><br /> The blisters containing the dried Zydis® units are then sealed via a heat-seal process to protect the product from varying environmental conditions and ensure long-term stability.</p></div> </div><div class="et_pb_module et_pb_image et_pb_image_0"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="680" height="440" src="https://www.catalent.com/wp-content/uploads/2019/06/Zydis-Manufacturing-Process.png" alt="A Zydis tablet is made using lyophilization. Firstly, the bulk API is formulated into a liquid solution or suspension. The liquid is then precisely filled into pre-formed blisters and passed through a cryogenic freezing process to control the size of the ice crystals, before the units are transferred to large-scale lyophilizers. Given that tablets made by freeze-drying can be sensitive to environmental conditions, the sealing and packaging process is also important. The blisters are subject to a heat-seal process to protect the product from varying environmental conditions and to ensure long-term stability." title="Zydis Manufacturing Process" srcset="https://www.catalent.com/wp-content/uploads/2019/06/Zydis-Manufacturing-Process.png 680w, https://www.catalent.com/wp-content/uploads/2019/06/Zydis-Manufacturing-Process-480x311.png 480w" sizes="auto, (min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 680px, 100vw" class="wp-image-213812" /></span> </div><div class="et_pb_module et_pb_divider et_pb_divider_7 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_14 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="capabilities"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>CATALENT CAPABILITIES</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_15 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">Through expert analysis and interpretation of data, our Zydis® fast dissolve technology team will fully characterize your API and associated Zydis® formulations throughout the development process to provide a robust data package in support of regulatory filings.</p> <ul style="padding-bottom:0"> <li>Feasibility programs & development teams</span> <ul style="padding-bottom:0"> <li>Tailored to meet the known product requirements such as API unit dose</li> <li>Consideration of the relevant API characteristics identified during the technical evaluation of preformulation data</li> <li>A range of prototype Zydis® formulations prepared under different processing conditions (bench-scale); analytical techniques applied as appropriate to determine the compatibility of a candidate API with the Zydis® technology</li> <li>Short-term (4 week) accelerated physical stability studies typically undertaken before recommendations for a full development program are made</li> </ul> </li> <li>Operational excellence and efficiency via Lean Six Sigma principles</li> <li>Full in-house analytical and regulatory services </span> <ul style="padding-bottom:0"> <li>Full characterization of your API and associated Zydis® formulations via expert analysis and interpretation of data throughout the development process to provide a robust data package in support of regulatory filings</li> <ul style="padding-bottom:0"> </li> <li>Smart full-lifecycle management from molecule to market – with Lean efficiency standards</li> <li>Expert handling and maximization of potent and controlled drugs</li> <li>Bench, pilot, and full-scale cGMP manufacturing</li> </ul></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_8 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_16 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="services"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>CATALENT SERVICES</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_17 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">We employ the most advanced equipment for our Zydis® fast dissolve preformulations and formulations. The resulting data is used to direct the selection of Zydis® formulators and manufacturing process conditions.</p> <p><strong>Optical microscopy</strong><br /> Characterizes the API crystal form and identifies any changes during formulation and processing</p> <p><strong>Freeze-drying microscopy</strong><br /> Identifies critical formulation parameters such as collapse temperature, eutectic/glass transition temperature</p> <p><strong>Particle size analysis (laser diffraction)</strong><br /> Determines particle size ranges relevant to Zydis® suspension stability for insoluable API</p> <p><strong>Dynamic Vapor Sorption</strong><br /> Characterizes moisture sorption properties and physical stability of lyophilized formulation in humidity</p> <p><strong>Characterization of hydrates and polymorphs</strong></p> <p><strong>X-ray powder diffraction (XRPD)</strong><br /> Characterizes solid-state phrase behavior</p> <p><strong>Characterization of moisture sorption properties and physical analytical chemistry (HPLC, UV, NIR, FTIR)</strong><br /> Chemical analysis of API in support of preformulation studies (e.g., solubility determinations, compatibility testing)</p></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_9 et_pb_divider_position_center et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_18 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="facilities"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>FACILITIES</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_19 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">Our Swindon, U.K. facility is dedicated to Zydis® unit production.</p> <ul> <li>Swindon, U.K. <ul> <li>Research and development</li> <li>Pilot line with controlled and potent drug capabilities</li> <li>FDA and MCA audited Controlled drug capabilities</li> </ul> </li> </ul> <p>All of our sites are subject to annual review so we can remain in highest compliance with:</p> <ul> <li>FDA/cGMP</li> <li> Canadian HPB</li> <li>British MHRA</li> <li>European Community</li> </ul></div> </div> </div> </div><div class="et_pb_row_inner et_pb_row_inner_1"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_1 et-last-child"> <div class="et_pb_module et_pb_divider et_pb_divider_10 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_20 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Related Topics</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_21 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a style="color: #0069aa" href="https://www.catalent.com/oral-dose/oral-technologies/modified-release-formulations/">Controlled Release</a></p></div> </div><div class="et_pb_module et_pb_text et_pb_text_22 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Expert Content</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_23 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a href="https://www.catalent.com/expert-content/oral-technologies/zydis-odt-unlocks-a-patient-preference-for-rapid-onset-in-the-treatment-of-migraine/">Rapid Onset in the Treatment of Migraine</a></p></div> </div><div class="et_pb_button_module_wrapper et_pb_button_0_wrapper et_pb_button_alignment_center et_pb_module "> <a class="et_pb_button et_pb_button_0 et_pb_bg_layout_light" href="https://www.catalent.com/contact-us/" data-icon="5">Contact Us</a> </div><div class="et_pb_module et_pb_image et_pb_image_1"> <a 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