A material-sparing method for simultaneous determination of true density and powder compaction properties--aspartame as an example.
True density results for a batch of commercial aspartame are highly variable when helium pycnometry is used. Alternatively, the true density of the problematic aspartame lot was obtained by fitting tablet density versus pressure data. The fitted true density was in excellent agreement with that predicted from single crystal structure. Tablet porosity was calculated from the true density and tablet apparent density. After making the necessary measurements for calculating tablet apparent density, the breaking force of each intact tablet was measured and tensile strength was calculated. With the knowledge of compaction pressure, tablet porosity and tensile strength, powder compaction properties were characterized using tabletability (tensile strength versus pressure), compactibility (tensile strength versus porosity), compressibility (porosity versus pressure) and Heckel analysis. Thus, a wealth of additional information on the compaction properties of the powder was obtained through little added work. A total of approximately 4 g of powder was used in this study. Depending on the size of tablet tooling, tablet thickness and true density, 2-10 g of powder would be sufficient for characterizing most pharmaceutical powders.
Sun
Changquan Calvin
CC
Pfizer Global Research and Development, 7000 Portage Road, Portage, MI 49001, USA. ccsun@amgen.com
D001218:Aspartame / Q000032:analysis* / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D019245:Compressive Strength; D003460:Crystallization; D004339:Drug Compounding; D010316:Particle Size; D016062:Porosity; D011208:Powders; D011312:Pressure; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013718:Tensile Strength; D014961:X-Ray Diffraction
D011208:Powders; D013607:Tablets; D001218:Aspartame