TY - JOUR T1 - Influence of granulation temperature on particle size distribution of granules in twin-screw granulation (TSG). AU - Ito,Akihiko, AU - Kleinebudde,Peter, Y1 - 2019/06/06/ PY - 2019/6/7/pubmed PY - 2019/12/4/medline PY - 2019/6/7/entrez KW - Granulation temperature KW - continuous wet granulation KW - particle size distribution KW - tableting KW - twin-screw extruder SP - 874 EP - 882 JF - Pharmaceutical development and technology JO - Pharm Dev Technol VL - 24 IS - 7 N2 - This study investigated an influence of granulation temperature during twin-screw granulation (TSG) on particle size distributions (PSDs). The influence of the granulation temperature on granule size distributions varied, depending on the liquid to solid (L/S) ratio, the kind of binders, the method of binder addition, and the filler material. The PSD of granules was broad and bimodal at a barrel temperature of 30 °C. Granules size distributions became narrow and second height decreased at high barrel temperature. While the L/S ratio had an effect on the sharpness of granule size distributions, this effect was minor compared to the granulation temperature. Granule size distributions were influenced by binder addition methods. When the binder was added as solution, PSD became broad. In formulations using lactose as filler, PSD became broad and bimodal at 90 °C. Much lactose was dissolved in granulation solution at high temperature, because the solubility of lactose rises significantly with the solution temperature leading to higher effective L/S ratio in the granulator. Hence, granulation was proceeded and large granules were formed. From these results, the granulation temperature is one of important parameters to obtain mono-modal PSD in TSG. SN - 1097-9867 UR - https://www.unboundmedicine.com/medline/citation/31169439/Influence_of_granulation_temperature_on_particle_size_distribution_of_granules_in_twin_screw_granulation__TSG__ DB - PRIME DP - Unbound Medicine ER -