abstract |
A solid pharmaceutical dosage form testing apparatus and a method are presented. The solid pharmaceutical dosage form testing apparatus includes a striker component, an impact platform, a sensor data acquisition system, and a solid dosage form placement mechanism. The solid dosage form placement mechanism has first and second push components that are movable toward each other to position a solid dosage form at an impact site. The method includes performing an impact strike test on a first plurality of solid dosage forms, and measuring a plurality of peak impact force values. The method may include performing a drop test on a second plurality of solid dosage forms, and measuring a plurality of physical defect rates. The method may include determining a model that describes a relationship between peak impact force values and physical defect rates, and determining, based on the model, a predicted physical defect rate. |