Validation of a manufacturing process of pellets for bone filling and drug delivery

Wet high shear granulation followed by heat treatment was used to manufacture calcium phosphate porous spherical pellets. Experimental conditions were determined in order to obtain pellets presenting required specifications, i.e. size of about 800 μm, maximum sphericity and high microporosity. These pellets were intended for bone defect filling and in situ drug delivery and the final step therefore consisted in ibuprofen loading. In a context of quality assurance, the aim of the present work was to validate each step of the manufacturing process (i.e. granulation, calcination and drug loading). Indeed, reproducibility of the pellet characteristics, especially the drug content and release kinetics from the ceramic to be implanted, has to be ensured through the manufacture quality control.