IBTROZI Capsule Ref.[115728] Active ingredients: Taletrectinib

IBTROZI (taletrectinib) capsules contain taletrectinib adipate, a kinase inhibitor for oral use. The molecular formula for taletrectinib adipate is C23H24FN5O•C6H10O4 and the molecular weight is 551.61 g/mol. The chemical name is 3-{4-[(2R)-2-aminopropoxy]phenyl}-N-[(1R)-1-(3-fluorophenyl)ethyl]imidazo [1,2-b]pyridazin-6-amine monoadipate. The chemical structure of taletrectinib adipate is as follows:

Figure 1. Structure of Taletrectinib Adipate:

(R) Indicates chiral center

Taletrectinib adipate is a white to yellowish powder and is practically insoluble or insoluble in water, anhydrous ethanol, isopropanol, acetonitrile, and n-hexane, sparingly soluble in methanol, and slightly soluble in N-methyl pyrrolidone. The aqueous solubility is pH dependent and decreases with increasing pH. The pKa1 is 5.39 and pKa2 is 8.65.

IBTROZI (taletrectinib) capsules for oral use are supplied as immediate-release hard capsules containing 272 mg of taletrectinib adipate (equivalent to 200 mg of taletrectinib free base). Inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, mannitol, pregelatinized starch, and sodium stearyl fumarate.

The white opaque capsule shell contains hypromellose and titanium dioxide. The blue printing ink (SB-6008) contains butyl alcohol, dehydrated alcohol, FD&C Blue#1 Aluminum Lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, and titanium dioxide.