Effect Of Powder Characteristics And Operating Conditions On Filling 1mg Weights Using An Xcelodose 600 Micro-Dosing System

The Xcelodose 600 powder micro-dosing system delivers powder directly into a hard gelatin capsule by controlling tapping of a dispensing head. IT is typically used to place unformulated active ingredients directly into capsule to accelerate "first in human:" studies. This system is capable of reproducibly dosing weights as small as 100ug when using suitable materialsl and optimized filling parameters.

The ability to control the flow of the materials is influenced by the physical characteristics of the powders and the configuration of the Xcelodose operating conditions. In general, freely flowing materials filled at low weights(0.1mg – 50mg) require a dispensing head that restrict the flow. Conversly, a poorly flowing material at higher weights ( 100mg) requires a less restrictive dispensing head. The optimum dispensing head is usually determined either by trail and error, or by historical data of similar materials and fill weights.

To better understand the influence of the various conditions on fill weight variations, two exciplents were selected for evaluation, hypromellose and pregelatinized starch. These excipients were chosen for their difference in flow properties while maintaining a similar particle size distribution. Each excipients was filled at a target weight of 1.0mg using four different dispensing heads and varying tapping frequencies. The dispensing head was kept continually fully of excipient during the filling process. The weight and time to achieve the target weight were monitored for each capsule produced.