Krzysztof Woyna-Orlewicz, Renata Jachowicz

Optymalizacja parametrów granulacji szybkoobrotowej w procesie wytwarzania tabletek zawierających trudno rozpuszczalną substancję leczniczą

High-speed granulation parameters optimization in robust manufacturing process. Highspeed granulation parameters were optimized in order to develop robust manufacturing process. The main compound of the formula was a slightly water soluble active pharmaceutical ingredient. The tested substance is of fine crystals, low bulk density, poor flowability and tends to stick to the stainless steel surfaces of manufacturing equipment. Amount of binding solution, impeller speed during massing and the massing time were found critical for the manufacturing process. These factors were optimized using three- level fractional factorial design. It was found that high levels of the tested factors cause not acceptable dissolution. Computation of the parameters levels were performed in order to set safe operational ranges.