The present invention relates to a pharmaceutical composition comprising a
fixed dose combination of (a) netupitant, or a salt or
hydrate thereof, and (b)
palonosetron, or a salt or
hydrate thereof, in a single pharmaceutical unit. The invention further relates to a method for preparing a pharmaceutical composition in the form of a tablet, the method comprises: (i) wet granulating a dry mixture comprising netupitant or a salt or
hydrate thereof, a filler, a binder, a disintegrant, and optionally a surfactant and / or a
lubricant, with a solution comprising
palonosetron or a salt or hydrate thereof, and optionally a surfactant and / or a binder, to produce granules; (ii) blending the particles with a
lubricant, a disintegrant and a
glidant, and optionally a filler, and (iii) compacting the lubricated particles to produce a tablet. The invention further relates to the use of said pharmaceutical composition for the treatment and / or prevention of
nausea and / or
vomiting, preferably for the treatment and / or prevention of acute or delayed
nausea and
vomiting associated with
chemotherapy, such as highly or moderately emetically induced
cancer chemotherapy, such as cis-
platinum cancer chemotherapy.