Comparison of low-shear and high-shear granulation processes: effect on implantable calcium phosphate granule properties.
BACKGROUND
Calcium phosphate porous ceramics present a great interest not only as complex bone defect fillers but also as drug delivery systems. Most of the methods described in the literature to fabricate pellets are based on compaction, casting into spherical molds, or on processes such as liquid immiscibility or foaming. Despite wet granulation is used in a wide range of applications in pharmaceuticals, food, detergents, fertilizers, and minerals, it is not applied in the biomaterial field to produce granules.


METHODS
In this study physicochemical and in vitro drug delivery properties of implantable calcium phosphate granules, produced by two wet agglomeration processes, were compared. Pellets obtained by high shear granulation (granulation in a Mi-Pro apparatus) were shown to be more spherical and less friable than granules elaborated by low shear process (granulation in a Kenwood apparatus). Although Mi-Pro pellets had a slightly lower porosity compared to Kenwood granules, ibuprofen loading efficiency and dissolution profiles were not statistically different and the release mechanism was mainly controlled by diffusion, in both cases.


CONCLUSIONS
Mi-Pro pellets appeared to be better candidates as bone defect fillers and local drug delivery systems as far as they were more spherical and less friable than Kenwood agglomerates.
Chevalier
E
E
Université de Limoges, CNRS SPCTS UMR 6638, Faculté de Pharmacie, Laboratoire de Pharmacie Galénique, Limoges, Cedex, France.
Viana
M
M
Cazalbou
S
S
Chulia
D
D
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000737:chemistry; D001672:Biocompatible Materials / Q000737:chemistry*; D001843:Bone Cements / Q000737:chemistry; D002130:Calcium Phosphates / Q000737:chemistry*; D002516:Ceramics; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004058:Diffusion; D016503:Drug Delivery Systems; D007052:Ibuprofen / Q000008:administration & dosage* / Q000737:chemistry; D016062:Porosity; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods
D000894:Anti-Inflammatory Agents, Non-Steroidal; D001672:Biocompatible Materials; D001843:Bone Cements; D002130:Calcium Phosphates; C020243:calcium phosphate; D007052:Ibuprofen