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Effect of Process Variables on the Content Uniformity of a Low Dose Drug in a High Shear Mixer

Withoon Kornchankul a , Neil H. Parikh b , and Adel Sakr a

Industrial Pharmacy Graduate Program, University of Cincinnati Medical Center a , Cincinnati, Ohio, and Chelsea Laboratories, Inc.b , Cincinnati, Ohio (USA)

Einfluß von Prozeßvariablen auf die Einheitlichkeit des Gehalts eines niedrig dosierten Wirkstoffs bei einem Schnellmischer

The purpose of this study was to investigate the effect of impeller speeds, chopper speeds, mixing times, and sampling locations on the content uniformity of 0.5 % w/w buspirone HCl in microcrystalline cellulose- based formulation. The formulation was mixed in a high shear mixer at various impeller speeds and chopper speeds from 0 to 32 min. Triplicate samples were taken from 9 locations in the mixer at each time point. Relative standard deviation of the drug content at each mixing time was calculated to indicate the extent of mixing uniformity. The statistical results indicated that impeller speeds and mixing times had significant effect on the content uniformity of the powder blend. The results also suggested that demixing occurred prominently when high chopper speed was used. For this study, the shortest time required to obtain good and steady content uniformity of the low dose formulation was 8 min of mixing with high impeller and high chopper speeds. It was concluded that the content uniformity of the low dose drug in the high shear mixer could be improved with the appropriate selection of impeller speed, chopper speed, and mixing time.

Key words Buspirone HCl · Content uniformity · High shear mixer · Low dose drug · Microcrystalline cellulose · Mixing, solid-solid · Powder blend