Tabrecta Description

TABRECTA is supplied for oral use as ovaloid, curved film-coated tablets with beveled edges, unscored containing 150 mg (pale orange brown color) or 200 mg (yellow color) capmatinib (equivalent to 176.55 mg or 235.40 mg respectively of capmatinib hydrochloride anhydrous).
Capmatinib is a kinase inhibitor. The chemical name is 2-Fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide-hydrogen chloride-water (1/2/1). The molecular formula for capmatinib hydrochloride is C₂₃H₂₁Cl₂FN₆O₂. The relative molecular mass is 503.36 g/mol for the hydrochloride salt and 412.43 g/mol for the free base.
Capmatinib hydrochloride is a yellow powder with a pKa₁ of 0.9 (calculated) and pKa₂ of 4.5 (experimentally). Capmatinib hydrochloride is slightly soluble in acidic aqueous solutions at pH 1 and 2 and of further decreasing solubility towards neutral condition. The log of the distribution coefficient (n-octanol/acetate buffer pH 4.0) is 1.2.
Excipients/Inactive Ingredients: Each tablet strength contains colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate as inactive ingredients.
The 150 mg tablet coating contains ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. The 200 mg tablet coating contains ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide.