Many compounds with stability issues at low pH require protection from acidic conditions in the stomach using delayed release coating systems, which allow bypassing stomach and release in duodenum, jejunum or colon. Compounds with short half-life or frequent daily dose can benefit from sustained release matrix formulations or membrane coating systems. BioDuro-Sundia has developed hundreds of products with controlled release coating or matrix systems for CTM manufacturing and has commercialized over twenty (20) products for clients.
BioDuro-Sundia’s manufacturing capabilities span from development to clinical trial material (CTM) for human trials (Phase I/II/III), Registration batches (1/10 scale or 100,000 unit) and validation batch manufacturing (full scale and at least 3 batches) and full scale Commercial.
Fluid-bed top spray and high shear wet granulation are main technologies used to prepare matrix sustained release granulations that are compressed into tablets.
To minimize any dose dumping due to unintentional cracking of sustained release coating systems, multi-particulates are utilized as cores. The multi-particulates are manufactured through drug layering onto sugar or MCC spheres, extrusion-spheronization or granulation compressed into mini-tablets. Such cores allow coating onto particles with defined surface area minimizing coating levels to achieve the desired release profile.
Tablets are used commonly as core substrate for enteric coating with pH dependent coating systems or other triggered mechanism e.g., enzymatic degradation. Coating levels are based on tablet surface area with constant mg/cm2 of coating regardless of tablet size. We have expertise in using methacrylate and modified cellulosic and other polymer-based formulations and processes for enteric protection.
BioDuro-Sundia has wet granulation, dry granulation, fluid-bed granulations from gram scales to hundreds of Kg of batch size to create immediate release (IR) pellets or tablet cores that can be further coated with modified release (MR) systems.
Both Wurster and Huttlin equipment are available for coating pellets and drug layered core particles at CTM scale, while at commercial scale we rely on our expert operators running Huttlin 200 and Huttlin 600 for manufacturing batches at several hundred of kg scale.
O’hara pan coaters are available for CTM manufacturing while four (4) units of 60” Thomas Engineering coating pans can manufacture metric tons of coated tablets when run simultaneously.