公开(公告)号：WO2019233887A1

公开(公告)日：2019-12-12

申请号：PCT/EP2019/064165

申请日：2019-05-31

Applicant: UNIVERSITAT DE BARCELONA

Inventor： SUÑÉ NEGRE, José María ,  MERCADÉ FRUTOS, Débora

IPC: A61K9/00 ,  A61K47/02 ,  A61K47/14 ,  A61K47/24 ,  A61K47/44 ,  A61K31/4409 ,  A61K31/4439 ,  A61K31/4965

Abstract: Kit of products for extemporaneous preparation of an oily suspension formulation comprising: (i) a dry powder composition of anti-tuberculosis effective amounts of the active pharmaceutical ingredients (APIs): isoniazid, rifampicin and pyrazinamide; and (ii) an oily liquid dispersing medium for reaching a predetermined volume of the suspension formulation, comprising: adequate amounts of the dispersing agents: ethoxylated hydrogenated castor oil, simethicone, and dichlorodimethylsilane-treated silica; adequate amounts of one or more flavoring agents; and the amount of medium-chain triglycerides, as oily base, that is necessary for reaching the predetermined volume of the suspension formulation; wherein (i) and (ii) are packaged in physically separated containers, arranged to be mixed extemporaneously to form the suspension formulation.The formulation is stable for more than three weeks under fridge conditions, and it is useful as a first-line treatment of tuberculosis in humans, particularly in children, with easy dose control, little effort, and good adherence.