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Influence of particle size and manufacturing conditions on the recrystallization of amorphous Enzalutamide
Authors: Svoboda Roman | Romanová Jana | Šlang Stanislav | Obadalova Iva | Komersová Alena
Year: 2020
Type of publication: článek v odborném periodiku
Name of source: European Journal of Pharmaceutical Sciences
Publisher name: Elsevier Science BV
Place: Amsterdam
Page from-to: "105468-1"-"105468-11"
Titles:
Language Name Abstract Keywords
cze Vliv velikosti částic na podmínek výroby na krystalizaci amorfního enzalutamidu Krystalizace amorfního enzalutamidu připraveného různými technikami byla studována pomocí neizotermní diferenční skenovací kalorimetrie. amorfní léčiva; enzalutamid; rekrystalizace; predikce; velikost částic
eng Influence of particle size and manufacturing conditions on the recrystallization of amorphous Enzalutamide Non-isothermal differential scanning calorimetry was used to study the influences of particle size and mechanically induced defects on the recrystallization kinetics of amorphous Enzalutamide. Enzalutamide prepared by hot melt extrusion and spray-drying was used as a model material. The recrystallization rate was primarily accelerated by the presence of the processing-damaged surface of the powder particles. The actual surface/volume ratio associated with decreasing particle size fulfilled only a secondary role. Interestingly, higher quench rate during the extrusion led to a formation of thermally less stable material (with the worse stability being manifested via lower activation energy of crystal growth in the amorphous matrix). This can be the consequence of the formation of looser structure more prone to rearrangements. The recrystallization kinetics of the prepared Enzalutamide amorphous materials was described by the two-parameter autocatalytic kinetic model. The modified single-curve multivariate kinetic analysis (optimized for the data obtained at heating rate 0.5 degrees C.min(-1)) was used to calculate the extrapolated kinetic predictions of long-term isothermal crystal growth. The predictions were made for the temperatures from the range of drug shelf-life and processing for each particle size fraction. By the combination of the mass-weighted predictions for the individual powder fractions it was possible to obtain a very reasonable (temperature-extrapolated) prediction of the crystallization rate for the asprepared unsieved powdered amorphous Enzalutamide. Amorphous drug; Enzalutamide; Recrystallization; Prediction; Particle size

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