Evaluation of Novel Co-Processed Excipients for Direct Compression Using the Sediment Delivery Model (SeDeM) Expert...

Background/Objectives: The development of multifaceted excipients is a requirement of the pharmaceutical industry. This study aimed to develop a granular co-processed excipient for tablets and to evaluate it using the SeDeM expert system. Methods: Four granule formulations were developed via the powder layering technique, varying binder concentrations (15% and 20%) and filler types (microcrystalline cellulose and lactose), using sugar as the core. The granules obtained were evaluated utilising the SeDeM expert system. The unloaded granules were compressed to yield uncoated compacted granules, which were verified for dimensional parameters, mechanical properties, and disintegration ability. Results: Varying binder concentrations (15% and 20%) together with differences in filler/disintegrant composition were associated with changes in particle-size distribution. During the SeDeM evaluation, E3 formulation exhibited good results in terms of parameter index (PI = 0.83), parameter profile index (PPI = 7.64), and Good Compressibility Index (GCI = 7.28). The recorded disintegration times were below 15 min for all compacted granules and complied with the Ph. Eur. 12 requirements for uncoated tablets. Conclusions: For granule development, variations in formulation composition, including binder concentration, were associated with differences in particle size and lubricity. The SeDeM expert system can be used in the preformulation studies to characterize powders or granule formulations from which uncoated tablets can be obtained, but there are several pharmacotechnical properties not included in the list of parameters that need to be analysed to comply with the industrial requirements.