Bioavailability and solubility enhancement

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} </style> </div> </div> </div> <style type="text/css"> #container-974967012{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-974967012 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--default--none aem-GridColumn--default--9 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--offset--default--0"> <div class="cmp-container-inner me-3 equalizeHeights h-100" id="container-159206425"> <div class="aem-Grid aem-Grid--9 aem-Grid--default--9 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--default--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--8 aem-GridColumn--offset--default--1"> <div id="text-38f9212864" class="cmp-text list-style-bullets"> <h2><br /> The majority of pipeline drugs experience solubility challenges</h2> <p>Solubility of <a href="https://www.patheon.com/us/en/our-capabilities/small-molecule/oral-solid-dose.html">oral solid dose</a> drugs presents an increasing threat to molecule advancement through the drug development pipeline, as a growing majority of current candidates are poorly soluble. If a drug cannot be dissolved and enter the bloodstream through the gastrointestinal tract, it will not reach systemic circulation and be available to provide its intended effect. Thus, to solve bioavailability challenges, solubility must first be addressed. Many solubility enhancement technologies and formulation options are available to developers, and the choices can be overwhelming. That’s why working with a partner with extensive experience and deep expertise in both <a href="https://www.patheon.com/us/en/our-capabilities/small-molecule/api-development.html">API and formulation development and manufacturing</a> is so critical.</p> </div> </div> </div> </div> <style type="text/css"> #container-159206425{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-159206425 { border-radius: px; } </style> </div> </div> </div> <style type="text/css"> #container-1647024434{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1647024434 { border-radius: px; } </style> </div> </div> </div> </div> <style type="text/css"> #well-1935476844 { border-radius: 0px; } </style> </div> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " style="background-color: #262262;background-position-x: center;background-position-y: center;" id="well-202888162"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="quadrant2" class="cmp-text list-style-bullets"> <p><span style="color: rgb(255,255,255);font-size: 35.0px;line-height: 130.0%;">Quadrant 2<sup>TM</sup></span></p> </div> </div> <div class="text aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--10 aem-GridColumn--offset--default--0"> <div id="text-f8f900c29e" class="cmp-text list-style-bullets"> <p><span style="color: rgb(255,255,255);font-size: 25.0px;line-height: 130.0%;">Predictive computational modeling using Patheon’s Quadrant 2™ platform can help you avoid months and even years of formulation setbacks. You provide your API’s chemical structure, any known physiochemical properties, and business and clinical objectives, and the Quadrant 2™ platform will predict the solubility enhancement technology and excipient combinations that are most likely to succeed.</span></p> </div> </div> <div class="cmp-key-takeaways aem-GridColumn--default--none aem-GridColumn--offset--xsmall--1 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--offset--default--2 aem-GridColumn--xsmall--9 aem-GridColumn--default--6"> <div class="takeaways-wrapper"> <div class="takeaway-card" style="color: #FFFFFF; border-color: #FFFFFF"> <i class="fak fa-globalbrand-analyze icon"></i> <div class="main-text"></div> <div class="sub-text"><h5 style="text-align: center;"><span style="font-size: 30.0px;"><b>90%</b></span></h5> <p class="p-claim" style="text-align: center;font-size: 30.0px;"><b>Technology selection accuracy</b></p> </div> </div> <div class="takeaway-card" style="color: #FFFFFF; border-color: #FFFFFF"> <i class="fak fa-globalbrand-clock icon"></i> <div class="main-text"></div> <div class="sub-text"><h5 style="text-align: center;"><span style="font-size: 30.0px;"><b>80%</b></span></h5> <p class="p-claim" style="text-align: center;font-size: 30.0px;"><b>Formulation selection accuracy</b></p> </div> </div> </div> </div> </div> </div> </div> <style type="text/css"> #well-202888162 { border-radius: 0px; } </style> </div> <div class="cmp-well aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--newline aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--12"> <div class="well " style="background-position-x: center;background-position-y: center;" id="well-1011845812"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-1085091567"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn aem-GridColumn--default--12"> <div id="text-66c86e4c21" class="cmp-text list-style-bullets"> <h3><b>Solubility enhancement techniques</b></h3> </div> </div> </div> </div> <style type="text/css"> #container-1085091567{ background-image: url(''); 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The jet milling process utilizes either a fluidized bed or centrifugation air jet pulverizer (pictured).</p> <p> </p> <p>Micronization takes place in a shallow, cylindrical chamber where a high-pressure air stream is injected along with the drug feed, creating a vortex, where size reduction is a result of the high-velocity collisions between particles. 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Finding an appropriate stabilizing polymer is a critical first step in the HME process. Analytical tools are used to understand the thermal properties of APIs and polymers, and in conjunction, Patheon’s Quadrant 2™ predicts optimal drug-polymer combinations and ratio options by assessing compatibility between functional groups (1). Once identified, the API and polymer are fed into the extruder (2) where the individual components are melted, mixed, homogenized, shaped by pressing through a die opening, (3), and then cooled and pelletized (4). </p> </div> </div> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner py-3 " id="container-2115049212"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--12 "> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-403638414"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="image aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-is="image" data-cmp-lazythreshold="0" data-cmp-src="/content/patheon/us/en/our-capabilities/small-molecule/oral-solid-dose/bioavailability-solubility-enhancement/_jcr_content/root/responsivegrid/well_1795178043_copy/container_1235906889_1027918362/accordion_copy_41993/accordionparsys/container_1655253706/container_1309222075/image.coreimg{.width}.png/1721742559171/hot-melt-extrusion-process.png" data-asset="/content/dam/patheon/global/site-images/bioavailability-solubility-solutions/hot-melt-extrusion-process.png" data-asset-id="fe732ecc-f511-4b37-bffc-8d1d95c40aff" data-title="Hot melt extrusion process" id="image-6ac5cb8eb6" class="cmp-image expandable false " itemscope itemtype="http://schema.org/ImageObject"> <img class="expand-icon" src="/etc.clientlibs/multisitecommons/clientlibs/clientlib-base/resources/images/expandIcon.png" alt="Expand Icon"/> <img src="/content/patheon/us/en/our-capabilities/small-molecule/oral-solid-dose/bioavailability-solubility-enhancement/_jcr_content/root/responsivegrid/well_1795178043_copy/container_1235906889_1027918362/accordion_copy_41993/accordionparsys/container_1655253706/container_1309222075/image.coreimg.png/1721742559171/hot-melt-extrusion-process.png" class="cmp-image__image popupEnabled " itemprop="contentUrl" data-cmp-hook-image="image" alt="Hot melt extrusion process" data-mfp-src="/content/patheon/us/en/our-capabilities/small-molecule/oral-solid-dose/bioavailability-solubility-enhancement/_jcr_content/root/responsivegrid/well_1795178043_copy/container_1235906889_1027918362/accordion_copy_41993/accordionparsys/container_1655253706/container_1309222075/image.coreimg.png/1721742559171/hot-melt-extrusion-process.png"/> </div> </div> </div> </div> <style type="text/css"> #container-403638414{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-403638414 { border-radius: px; } </style> </div> <div class="text aem-GridColumn--xsmall--12 aem-GridColumn aem-GridColumn--default--12"> <div id="text-7b4a092697" class="cmp-text list-style-bullets"> <p>Thermo Fisher Scientific can create micro-pellets that range from micrometers to a few millimeters (A), cut rods that range from millimeters to a few centimeters (B), and granules, (C) which can all be further processed or coated to prepare the final formulations including delayed or sustained release tablets. </p> </div> </div> </div> </div> <style type="text/css"> #container-2115049212{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-2115049212 { border-radius: px; } </style> </div> </div> </div> </div> </div> </div> </div> </div> </div> <style type="text/css"> #container-493234620{ background-image: url(''); 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Softgel is the most versatile OSD for in-vivo delivery of these lipid-based formulations. Manufacturing softgels using a rotary die process primarily follows three steps that include gel mass (shell) preparation (1), medicine (fill) preparation (2), and encapsulation of the medicine fill in the shell to form a hermetically sealed softgel capsule (3). The elegance of using lipid technology for poorly soluble drugs is the ability to deliver the drug in a liquid or semi-solid formulation, where the innate agitation mechanisms in the GIT create stable drug emulsions in solubilized or supersaturated states that can be absorbed into the bloodstream, improving bioavailability and drug efficacy (4).</p> </div> </div> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner py-3 " id="container-205905323"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--12 "> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-1929037789"> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--offset--default--0 aem-GridColumn--default--4"> <div class="cmp-container-inner p-3 equalizeHeights h-100" id="container-463052493"> <div class="aem-Grid aem-Grid--4 aem-Grid--small--12 aem-Grid--default--4 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--offset--default--0 aem-GridColumn--default--4 aem-GridColumn--small--4"> <div id="text-09844ae775" class="cmp-text list-style-bullets"> <p style="color: rgb(38,34,98);"><b>Advantages of using lipid formulations:</b></p> <ol style="line-height: 170.0%;"> <li style="color: rgb(38,34,98);line-height: 200.0%;"><b>Improved bioavailability</b></li> <li style="color: rgb(38,34,98);line-height: 280.0%;"><b>Enhance drug absorption</b></li> <li style="color: rgb(38,34,98);line-height: 200.0%;"><b>Stabilization of drug molecule</b></li> <li style="color: rgb(38,34,98);line-height: 200.0%;"><b>Flexible formulation options</b></li> <li style="color: rgb(38,34,98);line-height: 200.0%;"><b>Reduced food effect</b></li> <li style="color: rgb(38,34,98);line-height: 200.0%;"><b>Patient compliance</b></li> <p> </p> </ol> </div> </div> </div> </div> <style type="text/css"> #container-463052493{ background-image: url(''); 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Optimizing characteristics such as size and shape, particle size distribution, flow, density, bioavailability, and melting point enables more efficient formulation and manufacturing process development at the drug product stage. Our extensive capabilities and experience in solid state chemistry ensure that you receive the best solid form for your drug product development and scale-up.</p> </div> </div> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-2026867080"> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--12 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner p-3 equalizeHeights h-100" id="container-2108379374"> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--12"> <div id="text-6c368a01a5" class="cmp-text list-style-bullets"> <p style="color: rgb(38,34,98);"><b>Advantages of solid state chemistry:</b></p> <ol style="line-height: 170.0%;"> <li style="color: rgb(38,34,98);line-height: 200.0%;"><b>Better understanding of API chemical properties to ensure API stability, developability, and formulation fit</b></li> <li style="color: rgb(38,34,98);line-height: 280.0%;"><b>Improved solubility of poorly water-soluble API</b></li> <li style="color: rgb(38,34,98);line-height: 200.0%;"><b>Improved or optimized crystal modification, size and distribution, yield, purity, and processability</b></li> <p> </p> </ol> </div> </div> </div> </div> <style type="text/css"> #container-2108379374{ background-image: url(''); background-color: #F7F7F7; background-size: cover; background-position: center; min-height: px; } #container-2108379374 { border-radius: px; } </style> </div> </div> </div> <style type="text/css"> #container-2026867080{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-2026867080 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-1705484795"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-1001119817"> <div class="aem-Grid aem-Grid--6 aem-Grid--default--6 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6"> <div id="text-9f90db3c64" class="cmp-text list-style-bullets"> <div class="table-responsive" style="text-align: left;"><table cellspacing="0" border="1" style="border-color: rgb(255,255,255);font-size: 18.0px;" width="100%"> <tbody><tr><td width="35%" style="padding: 1.0%;border: solid thin;border-right: none;color: rgb(255,255,255);background: rgb(38,34,98);height: 75.0px;"><b>Basic characterization<br /> </b></td> <td style="padding: 1.0%;border: solid thin;border-left: none;color: rgb(255,255,255);background: rgb(38,34,98);text-align: right;font-size: 14.0px;"><b>Amount: 1-2 grams<br /> Time: 2 weeks </b></td> </tr><tr><td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><p><span style="color: rgb(38,34,98);font-size: 16.0px;">Recommended for all APIs at preclinical through Phase 1. Data typically gathered during characterization: </span></p> </td> <td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><span style="color: rgb(38,34,98);font-size: 16.0px;"><ul> <li>Identification of molecule</li> <li>Determine changes in crystal structure</li> <li>Assess process temperature on API structure</li> <li>Evaluate particle size/shape</li> <li>Formation of hydrates/solvates</li> <li>Assess API water/solvent interaction</li> <br /> </ul> </span></td> </tr></tbody></table> </div> </div> </div> </div> </div> <style type="text/css"> #container-1001119817{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1001119817 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--default--none aem-GridColumn--medium--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-1996186883"> <div class="aem-Grid aem-Grid--6 aem-Grid--default--6 aem-Grid--medium--6 "> <div class="text aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--medium--6"> <div id="text-fab8d7986a" class="cmp-text list-style-bullets"> <div class="table-responsive" style="text-align: left;"><table cellspacing="0" border="1" style="border-color: rgb(255,255,255);font-size: 18.0px;" width="100%"> <tbody><tr><td width="55%" style="padding: 1.0%;border: solid thin;border-right: none;color: rgb(255,255,255);background: rgb(255,165,0);height: 75.0px;"><b>Polymorph screening<br /> </b></td> <td style="padding: 1.0%;border: solid thin;border-left: none;color: rgb(255,255,255);background: rgb(255,165,0);text-align: right;font-size: 14.0px;"><b>Amount: 5-10 grams<br /> Time: 8-12 weeks</b></td> </tr><tr><td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><p><span style="color: rgb(38,34,98);font-size: 16.0px;">Polymorphs can have significantly different chemical, physical and potentially pharmaceutical activity. The selected form can also have a direct impact on the ability to manufacture both the API and drug product reproducibility. Polymorph screens typically consist of: </span></p> </td> <td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><span style="color: rgb(38,34,98);font-size: 16.0px;"><ul> <li>Assessment of process solvents & process conditions</li> <li>Characterization of unique forms</li> <li>Small scale assessment of selected conditions</li> <li>Stability evaluation</li> </ul> </span></td> </tr></tbody></table> </div> </div> </div> </div> </div> <style type="text/css"> #container-1996186883{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1996186883 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--default--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-171156581"> <div class="aem-Grid aem-Grid--6 aem-Grid--default--6 aem-Grid--medium--12 "> <div class="text aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6"> <div id="text-6194c2c0b8" class="cmp-text list-style-bullets"> <div class="table-responsive" style="text-align: left;"><table cellspacing="0" border="1" style="border-color: rgb(255,255,255);font-size: 18.0px;" width="100%"> <tbody><tr><td width="55%" style="padding: 1.0%;border: solid thin;border-right: none;color: rgb(255,255,255);background: rgb(180,180,180);height: 75.0px;"><b>Salt screening</b></td> <td style="padding: 1.0%;border: solid thin;border-left: none;color: rgb(255,255,255);background: rgb(180,180,180);text-align: right;font-size: 14.0px;"><b>Amount: 5-10 grams<br /> Time: 8-12 weeks</b></td> </tr><tr><td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><p><span style="color: rgb(38,34,98);font-size: 16.0px;">Developing a salt for a new molecule can support improvements in molecule solubility, processability and Bioavailability: </span></p> </td> <td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><span style="color: rgb(38,34,98);font-size: 16.0px;"><ul> <li>In-silico pK<sub>a</sub> determination</li> <li>Solubility assessment</li> <li>Selection of counter-ions</li> <li>Characterization of solids</li> <li>Solubility measurement of selected salts</li> <li>Further characterization</li> <br /> </ul> </span></td> </tr></tbody></table> </div> </div> </div> </div> </div> <style type="text/css"> #container-171156581{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-171156581 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--default--none aem-GridColumn--medium--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-1555667069"> <div class="aem-Grid aem-Grid--6 aem-Grid--default--6 aem-Grid--medium--6 "> <div class="text aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--medium--6"> <div id="text-2c5333255c" class="cmp-text list-style-bullets"> <div class="table-responsive" style="text-align: left;"><table cellspacing="0" border="1" style="border-color: rgb(255,255,255);font-size: 18.0px;" width="100%"> <tbody><tr><td width="60%" style="padding: 1.0%;border: solid thin;border-right: none;color: rgb(255,255,255);background: rgb(168,215,42);font-size: 16.0px;height: 75.0px;"><b>Early crystallization process development</b></td> <td style="padding: 1.0%;border: solid thin;border-left: none;color: rgb(255,255,255);background: rgb(168,215,42);text-align: right;font-size: 14.0px;"><b> Time: 4 weeks<br /> </b></td> </tr><tr><td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><p><span style="color: rgb(38,34,98);font-size: 16.0px;">Developing a crystalline drug substance has a positive impact on the molecules long term stability and processability. Crystal process development typically consists of: </span></p> </td> <td style="padding: 1.0%;border: solid thin;border-color: rgb(235,242,250);"><span style="color: rgb(38,34,98);font-size: 16.0px;"><ul> <li>Assessment of process solvents</li> <li>Scale-up experiments</li> <li>Characterization of yield/solid state properties</li> <li>Purification evaluation</li> <li>Particle size distribution</li> <br /> </ul> </span></td> </tr></tbody></table> </div> </div> </div> </div> </div> <style type="text/css"> #container-1555667069{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1555667069 { border-radius: px; } </style> </div> </div> </div> <style type="text/css"> #container-1705484795{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1705484795 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--xsmall--10 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner py-3 " id="container-1225057929"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn--xsmall--12 aem-GridColumn aem-GridColumn--default--12"> <div id="text-b48a01c167" class="cmp-text list-style-bullets"> <h4>Helpful resources </h4> </div> </div> </div> </div> <style type="text/css"> #container-1225057929{ background-image: url(''); 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