Quantification of the compactibility of pharmaceutical powders.
The purpose of this study is to investigate and to quantify the compactibility of pharmaceutical powders by a simple linear relationship between the diametral compressive strength of tablets and the applied compaction pressure. The mechanical strength of the tablets is characterized as the crushing force normalized with the dimension of the tablet and termed the specific crushing strength, SCS. The proposed model: SCS=Cp*P+b estimates the slope of the regression line Cp as a dimensionless compactibility parameter and is reported with the corresponding standard deviation SCp. The linear region of the compactibility profile is selected using the 95% predictability limits bordering the regression line. Eleven different materials were tested and acceptable fits to the linear model were observed in all cases. The ability of the model to discriminate between the investigated materials is excellent, in cases where the difference may be difficult to show a simple t-test is used as an inference tool. No difference was found between lactose tablets of different masses (500 and 1000 mg). A relationship between the compactibility parameter and the compressibility characterized by the Walker coefficient is demonstrated.
Sonnergaard
Jørn M
JM
Department of Pharmaceutics and Analytical Chemistry, The Danish University of Pharmaceutical Sciences, Copenhagen, Denmark. jms@dfuni.dk