Sodium Succinate → Cetirizine

Participants

Reaction Steps

As indicated in Table 1, Cetirizine Dihydrochloride, Beta-cyclodextrin, Sodium Succinate, and Corn Starch are charged into a Fluid Bed Granulator. Approximately 3000 g of Purified Water is then sprayed into the bed at approximately 75-125 g/minute and an inlet air temperature of approximately 55° C., using an atomization air pressure of 2 bar. Approximately 5680 g of the solution prepared in Step A is then sprayed onto the granulation at approximately 75 to 125 g/minute, using an inlet air temperature of approximately 55° C., using an atomization air pressure of 2 bar. Following spraying, the granulation is dried to a product temperature endpoint of approximately 30° C., or a Loss on Drying Analysis (LOD) of approximately 7.5%.

Provenance & Evidence