The use of sugar pellets or “sugar spheres” in multiparticulate 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. Factors that are critical to the success of this application are surface roughness and sphericity, particle size and its distribution, density, friability and the hardness of the starting substrate. Based on these criteria, the selection of the appropriate sugar pellet is actually the most crucial part of the formulation.
Colorcon® SureSpheres®, drug layering substrate, are ideal for creating sustained or extended release dosage forms. Available in seven different sizes, the smooth, spherical surface of the sugar spheres, combined with their low friability and high batch-to-batch uniformity provide the ideal surface for drug loading and tight particle control. SureSpheres possess all the physical properties that are optimal not only for a starting substrate, but also for pharmaceutical drug layering and subsequent coating and compression procedures.
The additional benefits of SureSpheres include the ability to withstand the rigors of drug layering, which allows for the accurate amount of the active pharmaceutical ingredient (API) in the finished product. The consistent surface of the sugar spheres allows for proper adherence of the API, and any selected coating later in the process. Most importantly, the use of SureSpheres results in precise drug release when combined with modified release coatings.
SureSpheres are 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 PEur.
Contact Colorcon to find out why SureSpheres should be your first choice for consistent quality!
