Evaluation of Pharmaceutical Blend Segregation Using High Throughput Automation

Description:
Segregation of a powder blend occurs with the separation of the individual constituents within a mixture. When analyzing pharmaceutical blends, segregation can affect the uniformity of the contents in a final dosage form. This can occur over a variety of different stages of development and manufacturing processes. Segregation risk testing is required to ensure a tablet’s uniformity. Typically, large scale experiments are run to test the segregation risk of powders, however this requires a large amount of powder and a large number of samples. In the research presented here, we attempt to demonstrate that small-scale batch testing can be used to produce results with that are comparable to the large-scale testing typically performed. Using a Mettler-Toledo Quantos QS30 powder dispensing balance, small-scale segregation tests were performed to help predict the segregation risk of several pharmaceutical blends. Nine different blends were tested, with four directly matching blends that have been commercially tested to provide direct comparison. Results show that similar trends are seen in these small-scale tests compared to the large ones: higher concentrations of the same compounds result in dispenses of higher precision and accuracy which corresponds to less segregation. We also conclude that drug particle characteristics impact the segregation propensity. These results presented in our research will demonstrate the feasibility of small-scale testing as first intent at a manufacturing scale.