569v Powder Flow Characterization from Avalanche Behavior

Jose E. Tabora, Ryan Cullen, Steven Chan, and Steve Wang. Bristol-Myers Squibb, One Squibb Drive, New Brunswick, NJ 08901

Characterization of powder flow is an important aspect in determining the manufacturing process of active pharmaceutical ingredients (API). The Aeroflow® is a commercial flowability analyzer which measures the avalanche behavior of a powder in a constantly rotating disc. Generally the mean time to avalanche (MTA) and the scatter is measured and used as a comparative value of the flow properties of the powder. Previous work [1] suggests that the underlying dynamics from this process are chaotic. In this work the raw data is converted to a spike train denoting the time and intensity of the avalanche. Non-linear statistical analysis is performed on the time series to characterize the underlying non-linear process involved. This methodology was applied to a series of lots of API's manufactured at pilot plant scale under different processing conditions. The results are compared to conventional powder characterization.

[1] B.H.Kaye, J. Gratton Liimatainen, N. Faddis, Particle System Characterization, 1995, 12, 232-236