Why not choose DC co-processed excipients in your ODT formulation?

Direct compression (DC) is the simplest process to manufacture tablets. The advantage of DC is that the simplicity of the manufacturing process can reduce manufacturing costs and manufacturing time. On the other hand, we often encounter challenges, such as tableting trouble, tablet weight fluctuation, and difficulty in maintaining content uniformity, as the powder properties of raw materials directly affect the DC process. Co-processed excipients (CPEs) are applicable to DC and can overcome such challenges that are difficult to solve with simply mixed powders.

In this article we introduce a recent study conducted by the research team at Heinrich Heine University demonstrating the advantages of CPEs in comparison to physically mixed powders of the same composition as CPEs. Daicel’s CPEs, HiSORAD® HSR-D03 (HSR) and GRANFILLER-D® GNF-D211 (GNF) are designed for orally disintegrating tablets (ODTs), which perform fast disintegration under practical tablet hardness. Here we compare these CPEs to physical mixtures of the same composition in terms of flowability, compactability and disintegratability.

According to flowability, we evaluated flowability with Carr’s flowability Index and the shear test method. Both experiments show better flowability of CPEs than that of physical mixtures in all evaluations. It is attributed to the reduction of fine powder due to granulation of CPEs. Tablet performance was also compared to physical mixtures of the same composition. Both CPEs have higher tablet hardness than physical mixtures, indicating better compactability. Both CPEs contain D-mannitol which is often described as a low-compressible excipient, however, the granulation manufacturing process gives the CPEs good compactibility Furthermore, the CPEs have better disintegratability than physical mixtures especially in the region of higher tensile strength.

See the full Daicel whitepaper here:
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