DIRECTLY COMPRESSIBLE HIGH FUNCTIONALITY GRANULAR DIBASIC CALCIUM PHOSPHATE BASED CO-PROCESSED EXCIPIENT

摘要

An improved excipient comprising substantially homogeneous particles of a compressible, high functionality granular dibasic calcium phosphate based excipient is provided. The improved excipient comprises dibasic calcium phosphate, a binder and a disintegrant, and is formed by spraying a homogeneous slurry of the components. The improved excipient provides enhanced flowability/good flow properties, an increased API loading and blendability and higher compactibility as compared to the individual components, and as compared to excipients formed from the same materials by conventional methods. [0083] The improved excipient has strong intraparticle bonding bridges between the components, resulting in a unique structural morphology including significant open structures or hollow pores. The presence of these pores provides a surface roughness that is the ideal environment for improved blending with an API.