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International audience; This paper describes a systematic approach to select optimum stabilizer for the preparation of nano-crystalline suspensions of an active pharmaceutical ingredient (API). The stabilizer can be either a dispersant or a combination of dispersant and wetting agent. The proposed screening method is a quick and efficient way to investigate a large number of stabilizers based on the principles of physical-chemistry and employs a stepwise approach. The methodology has been divided in two main parts; the first part being focused on the qualitative screening with the objective of selecting the best candidate(s) for further investigation, the second part has been focused on quantitative screening with the objective to optimize the ratio and amount of wetting and dispersing agents, based on wettability, surface charges measurement, adsorption evaluation, process-ability evaluation and storage stability. The results showed clearly that SDS/PVP 40/60% (w/w) (sodium dodecyl sulfate/poly(vinyl pyrrolidone)) at a total concentration of 1.2% was the optimum stabilizer composition, at which the resulting nanosuspensions were stable for more than 50 days at room temperature.

Issu de : WCPT6 2010 - 6th World congress on particle technology, Nuremberg, GERMANY, 26-29 April 2010; International audience; In dry coating processes no liquid, solvent, binder or water, is required. This makes them advantageous compared to wet coating alternative: being low cost, no drying step required, environmentally friendly (no volatile organic compounds related problems) and simple in operation. But there is still a lack of fundamental knowledge of the implied mechanisms. Often the process itself has been empirically designed and is not always well characterized. In this work, some hydrodynamic elements are developed in a high energy mixer used for dry coating: the specific behavior of the Nara hybridizer NHS-0 is investigated. In the first part, recirculation velocities and temperatures are derived during the process, or when the purge is on. The effects of the pressure purge and of the rotor velocity on the purge and the effect of the rotation on the temperature increase are studied. In the second part, a simple experimental approach is carried out to derive qualitatively the local temperature inside the apparatus with the help of polymers with different melting temperatures. This approach illustrates a first step for dry coating application with waxes.