{"id":987502939,"date":"2026-06-10T21:20:42","date_gmt":"2026-06-10T21:20:42","guid":{"rendered":"https:\/\/boracdmo.com\/?p=987502939"},"modified":"2026-06-10T22:44:05","modified_gmt":"2026-06-10T22:44:05","slug":"how-modified-release-technologies-empower-more-patient-centric-drug-design","status":"publish","type":"post","link":"https:\/\/boracdmo.com\/how-modified-release-technologies-empower-more-patient-centric-drug-design\/","title":{"rendered":"Engineering for today: How modified release technologies empower more patient-centric drug design"},"content":{"rendered":"\t\t
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As small-molecule therapeutics become increasingly complex, drug developers seek processing technologies that overcome formulation limitations and support patient-centric drug design. Pharma companies are increasingly turning to CDMOs to leverage these technologies and the expertise necessary to apply them. Multi-particle, multi-sphere finished-dose forms offer drug developers efficient and flexible ways to explore complex patient-centric design strategies for oral solid dose (OSD)<\/a> drugs. Multi-particle systems have demonstrated desirable and reproducible pharmacokinetic and pharmacodynamic profiles, even for insoluble APIs, resulting in more consistent therapeutic performance across patient populations. For drug designers looking to develop patient-centric OSDs, these finished-dose forms are offering new flexibility and utility.<\/p>

Supporting patient-centric drug design<\/strong><\/h3>

Over the past decade, the pharmaceutical sector has gradually shifted its emphasis from treating disease in the abstract to a more patient-centric, holistic approach. Patient-centric drug design unites strategies that maximize efficacy while tailoring features to a patient population\u2019s unique needs. Modified release formulations<\/a>, for example, can be effective for delivering drug substances that have a narrow therapeutic index or need to be in an OSD form to promote dose adherence. Broadly, orally administered drugs are the preferred dose form across patient populations. Most patient groups respond well to taking oral medications that are easy to swallow, require fewer doses over time, and minimize or eliminate unpleasant side effects.<\/p>

Extrusion-spheronization (E-S) has emerged as a powerful technique to effectively manipulate solubility and bioavailability in OSD formulations. E-S is a manufacturing process in which a wet mass is extruded into cylindrical strands and then rounded into uniform spherical pellets (multiparticulates) through spheronization. By manipulating the dynamics of extrusion and spheronization, manufacturers can control formulation traits and, by blending particle size and density, achieve different release patterns over time. The dose control allowed by E-S can also help reduce side effects, manage gastrointestinal irritation or discomfort caused by dispersion or concentration issues, or target release in the lower intestine to avoid acidic environments. Additionally, by permitting high drug loading, E-S enables less frequent dosing requirements and, in turn, promotes patient adherence.<\/p>

The extrusion-spheronization process<\/strong><\/h3>

E-S consists of four primary steps:<\/p>

  1. Mixing <\/strong>– E-S begins with mixing a combination of API, excipients or binders, and sterile water in desired ratios to create the wet granulation batch ready for extrusion. Depending on desired density, mix homogeneity, and flow needs, processors can manipulate mixer shear loading, speed, and other variables to achieve desired properties. The ultimate goal of mixing is to create a soft, wet, homogenous mass that can hold its shape under low pressure and has sufficient gliding properties to keep extrusion flowing and pressures low.<\/li>
  2. Extrusion<\/strong> – The primary objective of extrusion is to produce extrudates suitable for spheronization. The process consists of forcing the mass of wet cake from a large diameter through a small diameter. Extrusion can be accomplished through several technological routes, and equipment manufacturers currently offer a broad range of systems to meet formulation and manufacturing needs.<\/li>
  3. Spheronization<\/strong> – Spheronization is essentially a milling operation that tumbles the wet cake extrudates into uniform spherical shapes. Spheronizers employ a spinning friction plate that, through centrifugal force and friction, generates microcollisions that eventually shape cylindrical extrudates into spheres. By manipulating processing time, moisture content, and friction plate configuration\/speed, technicians can control particle size distribution and particle density.<\/li>
  4. Drying\/Coating<\/strong> – To complete the process, the uniform spheres can be dried and\/or coated to achieve drug delivery goals such as controlled release or taste masking. Equipment suppliers now offer the industry a variety of coating and drying systems capable of finishing E-S spheres to meet a broad range of OSD API delivery goals and the therapeutic performance of the finished drug product.<\/li><\/ol>

    Fine-tuning API release with extrusion-spheronization <\/strong><\/h3>

    Offering processing accuracy and quality control, spheronization is an effective way to reduce variability in drug production. Because of the efficiencies gained through high drug loading and other formulation characteristics, the process can improve manufacturing efficiency without compromising quality.<\/p>

    For example, single APIs often require dispersion throughout a solid matrix to control release in an OSD formulation. These matrices can limit the rate at which active ingredients are dispersed into the body, achieving a desired pharmacokinetic profile. While this can be accomplished with various methods, E-S offers a reliable, flexible alternative to other spheronization or pellet agglomeration manufacturing techniques like coating or layering. The API core can be integrated with release excipients, eliminating the need for subsequent dose-controlling coatings. Furthermore, drug pelleting via E-S can provide manufacturing efficiencies compared to traditional drug layering approaches.<\/p>

    Bora\u2019s extrusion-spheronization capabilities <\/strong><\/h3>

    To support partners with E-S capabilities<\/a>, Bora has invested in its global facilities, introducing a continuous processing line. Certified by all leading international regulators, Bora\u2018s E-S offerings comply with PIC\/S, GMP, and GDP guidance for all drug products. All production activities related to E-S processing are conducted in temperature- and relative humidity-monitored areas. Process rooms have individual temperature and humidity recorders installed to maintain optimal conditions.<\/p>

    Experienced CDMO partners can help accelerate the path to market and provide formulation expertise to guide E-S processes. However, to fully leverage spheronization in commercial manufacturing, the process requires both the knowledge and the operational investment necessary to do it well and meet all commercial, financial, and regulatory expectations. Bora\u2019s formulation skills <\/a>and experience, combined with continuous-flow E-S infrastructure, provide a strong foundation to support and optimize customers\u2019 OSD commercialization plans.<\/p>

    To learn more about extrusion-spheronization and Bora\u2019s OSD formulation services, contact a Bora expert<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    Explore how extrusion-spheronization and modified release technologies enable more patient-centric oral solid dose design, formulation flexibility, and optimized drug delivery.<\/p>\n","protected":false},"author":38,"featured_media":987502899,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-987502939","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles"],"aioseo_notices":[],"acf":[],"_links":{"self":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/987502939","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/users\/38"}],"replies":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/comments?post=987502939"}],"version-history":[{"count":2,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/987502939\/revisions"}],"predecessor-version":[{"id":987502944,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/987502939\/revisions\/987502944"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/media\/987502899"}],"wp:attachment":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/media?parent=987502939"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/categories?post=987502939"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/tags?post=987502939"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}