A new drug layering substrate, called SureSpheres, designed to aid consistent drug release and more accurate dosing, has been developed by Colorcon.
SureSpheres consists of uniform, free flowing pellets made of sucrose and starch. The use of sugar pellets or "sugar spheres" in multi-particulate drug delivery systems has been an area of continued interest in the pharmaceutical industry. This is largely due to the clinical and formulation advantages sugar pellets have over single-unit dosage forms, including the ease of processing them in modified release applications.
According to Colorcon, SureSpheres exhibit consistency in critical factors such as surface roughness, sphericity, particle size and distribution, density, hardness and friability. This product consistency provides an accurate dose of the active pharmaceutical ingredient (API) in the finished product. The uniform surface of the sugar spheres allows for proper adherence of the API, and any selected coating applied later in the process. Most importantly, the use of SureSpheres results in precise drug release when combined with modified release coatings, it says.
"SureSpheres provide the formulator a high quality, consistent starting substrate for their multiparticulate formulations," said Michael McDougal, director - excipient portfolio.
The product is in compliance with applicable excipient GMP requirements based on the USP/NF General Chapter and Good Manufacturing Processes for Bulk Pharmaceutical Excipients. They also meet all specifications for sugar spheres as outlined in the current version of the USP/NF, JPE and PhEur.