In drug production, manufacturing efficacy and the effectiveness of the final product (i.e., bioavailability, content uniformity, compression uniformity, ease of ejection, etc.) largely depends on the blending process. Not only do the chosen excipients used in the formulation matter, but any modification of these materials can contribute to major differences in the length of blending needed as well as the functionality of the blend, itself.
PROSOLV® SMCC (Co-processed Silicifed Microcrystalline Cellulose) was developed by JRS Pharma over 20 years ago. This monographed, Inactive Ingredient Database (IID) listed, highly functional excipient has been well regarded in formulation and processing. PROSOLV® SMCC improves compactability, exhibits superior flow, and enhances mixing characteristics, optimizing content uniformity thus enabling rapid formulation development. Direct compression processing remains the most economical process within pharmaceutical manufacturing due to a smaller processing equipment footprint with less steps and lower energy costs.
In this study, a series of blending experiments evaluated the uniformity of caffeine in blends with the co-processed excipient silicified microcrystalline cellulose (PROSOLV® SMCC) versus physical blends of microcrystalline cellulose and the glidant colloidal silicon dioxide (CSD). The blending process was monitored with Near-Infrared Spectroscopy (NIRS). The effects of mixing on particle size attenuation were investigated by measuring each of the resultant blends with a LASER lightscattering (LLS) device. The blends were tableted and the results (ejection force, hardness, and assay) compared.
For this un-optimized formulation with a challenging active, use of co-processed PROSOLV® SMCC yielded robust formulations with significant benefits over using MCC blended with CSD glidant. These benefits included faster blend uniformity and improved tablet content uniformity, as well as both increased tablet hardness and reduced ejection forces. PROSOLV® SMCC can be used to simplify formulation optimization and process scale-up, potentially avoiding costly reworks later on.