MORPHIC FORMS OF TRILACICLIB AND METHODS OF MANUFACTURE THEREOF
An advantageous isolated morphic form of trilaciclib which is 2′-((5-(4-methylpiperazin-1-yl)pyridin-2-yl)amino)-7′,8′-dihydro-6′H-spiro[cyclohexane-1,9′-pyrazino[1′,2′:1,5]pyrrolo[2,3-d]pyrimidin]-6′-one, for example in the form of a di-hydrochloride salt or a dihydrochloride, dihydrate.
1 . A pharmaceutical composition comprising a dihydrochloride salt of a compound of structure:
mannitol, and citric acid.
2 . The pharmaceutical composition of claim 1 comprising between 250 and 35° milligrams of mannitol.
3 . The pharmaceutical composition of claim 1 comprising about 300 milligrams of mannitol.
4 . The pharmaceutical composition of claim 1 comprising between 50 and 100 milligrams of citric acid.
5 . The pharmaceutical composition of claim 1 comprising about 76 milligrams of citric acid.
6 . The pharmaceutical composition of claim 5 , wherein the citric acid is a monohydrate.
7 . The pharmaceutical composition of claim 1 comprising between 200 and 600 milligrams of the compound.
8 . The pharmaceutical composition of claim 1 comprising about 349 milligrams of the compound.
9 . The pharmaceutical composition of claim 8 comprising between 250 and 35° milligrams of mannitol.
10 . The pharmaceutical composition of claim 8 comprising about 300 milligrams of mannitol.
11 . The pharmaceutical composition of claim 10 comprising between 50 and 100 milligrams of citric acid.
12 . The pharmaceutical composition of claim 10 comprising about 76 milligrams of citric acid.
13 . The pharmaceutical composition of claim 12 , wherein the pharmaceutical composition is lyophilized.