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Real-time-monitoring of pharmaceutical properties of medical tablets during direct tableting process by hybrid-tableting-process parameter-time profiles.

BACKGROUND
Real-time monitoring is required for the pharmaceutical manufacturing process to produce high-quality pharmaceutical products.


OBJECTIVE
Changes in the critical tableting process parameters of single-punch tableting machine due to variability in the moisture content of the raw powders were monitored by hybrid tableting pressure-time profiles.


METHODS
After mixing of the raw powders consisted of theophylline, anhydrous lactose, potato starch and crystalline cellulose, were stored at 0%, 45%, or 75% relative humidity (RH) for 24 h, respectively. Continuous tablet productions were carried out using the mixed powder samples at 10%, 45%, or 75% RH, respectively. The critical process parameters, such as upper and lower puncture pressures, die wall pressures, and inter-punch distances were recoded with the tableting machine, and then, tablet hardness (H), weight (W) and disintegration time (DT) of the tablets were measured.


RESULTS
Hybrid tableting pressure-time profiles were obtained from various critical process parameters, and calibration models to predict pharmaceutical properties were calculated based on the hybrid profiles using a partial-least-squares regression (PLSR) method. In addition, the consistency of the calibration models were verified by constructing of robust calibration models.


CONCLUSION
Informetrical analysis for tablets based on hybrid tableting pressure-time profiles could be evaluated change of tablet properties dependent on the moisture content in the raw powders during the tableting process. The changes of tableting properties and elasticity were caused by agglomeration of powder particles at moisture content.