Abstract

Objective: To evaluate and compare the particle and tableting properties of a new sorbitol (SOR) and anhydrous calcium diphosphate (ACD) composite with common excipients used for the preparation of tablets by direct compression such as polyvinylpyrrolidone (Ludipress®), lactose (Cellactose 80®) and microcrystalline cellulose (Prosolv SMCC 90®). Methods: All materials were tested for lubricant sensitivity, ejection force, and elastic recovery, dilution potential and reworking ability. Further, compressibility and compactibility were determined using the Heckel and Leuenberger models, respectively. Results: This new excipient offered more benefits in terms of functionality than commercial direct compressive co-processed excipients and showed better compressibility than other commercial excipients and its compactibility was ranked third after SOR and Prosolv SMCC 90®. However, this composite material was more susceptible to reprocessing than commercial products. Further, it showed a low lubricant sensitivity due to a combination of a plastic and brittle behavior. Moreover, the loading capacity of poorly compressible materials such as gemfibrozil was comparable to that of commercial direct compression excipients. It also showed the fastest in-vitro dissolution of gemfibrozil, whereas commercial products failed to fulfill the US pharmacopoeial requirements. Conclusion: This new composite material showed potential for use as a direct compression excipient.