Modified Release Drug Product Overview
BioDuro-Sundia specializes in innovative solutions for compounds with stability or dosing challenges. Our expertise in delayed and sustained release systems ensures precise drug delivery to the duodenum, jejunum, or colon. With hundreds of controlled-release products developed and over 20 successfully commercialized, we offer full-service manufacturing from clinical trial material to commercial-scale production.
Delayed, sustained and custom release
Tablets, mini-tablets, capsules
Development and manufacturing
Compounds with stability issues at low pH
Compounds with a short half-life
Capabilities for hundreds of finished products
Matrix Systems
Fluid-bed top spray and high shear wet granulation are main technologies used to prepare matrix sustained release granulations that are compressed into tablets.
Multi-Particulate Systems
To prevent dose dumping and ensure consistent release, BioDuro-Sundia uses multi-particulate cores in sustained release formulations. These cores are created through advanced techniques like drug layering on sugar or MCC spheres, extrusion-spheronization, or granulation into mini-tablets. This approach optimizes coating precision, delivering the desired release profile with minimal coating levels
Tablets
BioDuro-Sundia specializes in enteric-coated tablet formulations for targeted drug release, using pH-dependent or enzyme-triggered mechanisms. Our expertise in methacrylate, modified cellulose, and advanced polymer-based coatings ensures precise protection and delivery, regardless of tablet size
Equipment
BioDuro-Sundia offers versatile granulation capabilities—wet, dry, and fluid-bed—from small gram scales to hundreds of kilograms for creating immediate-release (IR) pellets and tablet cores, which can be coated with modified-release (MR) systems. Our advanced Wurster and Huttlin equipment handles pellet and core coating at CTM scale, while our expert operators manage large commercial batches with Huttlin 200 and 600 systems, delivering consistent results. For tablet coating, we use O’Hara pan coaters at CTM scale and can produce metric tons of coated tablets using our four 60” Thomas Engineering pans for large-scale manufacturing
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