公开(公告)号：EP4389116A1

公开(公告)日：2024-06-26

申请号：EP23151010.8

申请日：2023-01-10

申请人： Dechra Ltd

发明人： MICHIELS, Henricus Fransiscus Catharina ,  FOLMER, Brigitte Johanna Bernita ,  LEJEUNE, Stephan Jacob

IPC分类号： A61K9/10 ,  A61K47/10

CPC分类号： A61K47/10 ,  A61K9/0056 ,  A61K9/10 ,  A61K9/146 ,  A61K31/4184 ,  A61P33/00 ,  A61P33/10

摘要： The present invention relates to a pharmaceutical aqueous suspension comprising: at most 35 wt.% of flubendazole, based on the weight of the pharmaceutical aqueous suspension, as solid particles having a particle size distribution in which D50 ≤ 0.45 micrometer and ≥ 90 % of particles are ≤ 1.0 micrometer; a non-ionic triblock copolymer surfactant comprising a central polypropylene oxide)-block having at least 30 propylene oxide (PO) units, flanked by two poly(ethylene oxide)-blocks, each having at a certain number of ethylene oxide (EO) units, wherein the ratio of number of PO units to total number of EO units is at least 0.2, one or more preservatives, and water. In addition, the present invention relates to a medicated water and a concentrated water comprising water and the pharmaceutical aqueous suspension as well as to a process of preparing a pharmaceutical aqueous suspension and to a use of the pharmaceutical aqueous suspension for the treatment of internal parasites in mammals, such as poultry and pigs.