Process and formulation characterizations of the thermal adhesion granulation (TAG) process for improving granular properties.

In this study, we demonstrate the feasibility of using the thermal adhesion granulation (TAG) method to improve granular properties for preparing highly compressible excipients as direct tabletting aids. The TAG method subjects a mixture containing excipients, such as microcrystalline cellulose (MCC), lactose, starch, or dibasic calcium phosphate (DCP), under closed conditions with a low moisture content and low content of polyvinyl pyrrolidone (PVP) as a binder, to heating during mixing by tumble rotation to produce highly compressible granules. Results demonstrated that a closed system is more efficient than an open system at such a low moisture content, and both water and ethanol were able to fulfill the role of a granulation liquid, but water was more appropriate than ethanol for successfully producing granules suitable for use as direct tabletting aids by the TAG method.