Mehta1, E. Sternberger-Ruetzel1, H. Peters.2 & O. Imole3
1Harro Höfliger Verpackungsmaschinen GmbH, Helmholtzstraße 4, 71573 Allmersbach i.T, Germany
2DFE Pharma, Transistorweg 5, 6534 AT Nijmegen, The Netherlands
3Hosokawa Micron B.V., Gildenstraat 26, 7005 BL, Doetinchem, The Netherlands
Summary
Filling low amount of powders for inhalation into blisters is a challenging process. Limited knowledge is available on the use of magnesium stearate as ternary agent in inhaled formulations and its effect on the filling of powders into the blisters. A study was initiated to understand the interaction of lactose fines and magnesium stearate on the flow and the filling of powders into blisters. The particle size fraction below 30µm showed a strong correlation with the compressibility and permeability of the lactose and lactose magnesium stearate blends. An increase in this fraction increases the compressibility, permeability and the fill weight of the powders. Blends having permeability values higher then 6, consistently showed lower relative standard deviation values (below 3.0%) in fill weight. This insight will help to develop robust dry powders for inhalation.
Key Message
Strong correlations have been found between lactose particles below 30µm and compressibility as well as permeability for blends with and without magnesium stearate. For the membrane filling systems, permeability and compressibility are important parameters to tune the relative standard deviations and mean fill weight.