EP4385497A1 — Antioxidant-free fixed dose combination of netupitant and palonosetron

USPTO Abstract

The invention relates to a pharmaceutical composition comprising a fixed dose combination of (a) Netupitant or salt or hydrate thereof, and (b) Palonosetron or salt or hydrate thereof, in a single pharmaceutical unit, wherein the pharmaceutical composition does not comprise an antioxidant. The invention further relates to a method of preparing a pharmaceutical composition in the form of a tablet, the method comprising: (i) wet granulating a dry mixture comprising Netupitant or a salt or hydrate thereof, 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 granules with a lubricant, a disintegrant and a glidant, and optionally a filler, and (iii) compressing of the lubricated granules to produce a tablet. The invention further relates to the pharmaceutical composition for use in the treatment and/or prevention of nausea and/or vomiting, preferably in the treatment and/or prevention of acute or delayed nausea and vomiting associated with chemotherapy, such as highly or moderately emetogenic cancer chemotherapy, for example cisplatin cancer chemotherapy.