Salt forms of sabcomeline
The invention relates to the pamoate salt of sabcomeline. The pamoate salt of sabcomeline may be a solid, preferably in a crystalline solid. The invention also relates to various polymorphic forms of sabcomeline pamoate salt. The invention further relates to methods of preparing the pamoate salt of sabcomeline and its various polymorphic forms and to pharmaceutical compositions containing the pamoate salt of sabcomeline and its various polymorphic forms.
1 . Crystalline sabcomeline pamoate exhibiting X-ray powder diffraction (XRPD) pattern 2θ peaks at 10.5±0.2, 16.5±0.2, 19.8±0.2, 21.1±0.2 and 22.9±0.2.
2 . The crystalline sabcomeline pamoate of claim 1 , further exhibiting XRPD pattern 2θ peaks at 7.9±0.2, 9.5±0.2, 12.6±0.2, 15.8±0.2.
3 . The crystalline sabcomeline pamoate of claim 1 , further exhibiting XRPD pattern 2θ peaks at 19.0±0.2, 20.7±0.2, 22.2±0.2, 24.8±0.2.
4 . A pharmaceutical composition comprising the crystalline sabcomeline pamoate of claim 1 and at least one pharmaceutically acceptable excipient.
5 . The pharmaceutical composition of claim 4 , wherein the crystalline sabcomeline is present in the composition as a single polymorphic form.
6 . The pharmaceutical composition of claim 4 , wherein the crystalline sabcomeline is present in the composition as a mixture of two or more polymorphic forms.
7 . A method of making crystalline sabcomeline pamoate, the method comprising crystallizing sabcomeline pamoate from a solvent and collecting crystallized sabcomeline pamoate, wherein the collected crystalline sabcomeline pamoate exhibits X-ray powder diffraction (XRPD) pattern 2θ peaks at 10.5±0.2, 16.5±0.2, 19.8±0.2, 21.1±0.2 and 22.9±0.2.
8 . A pharmaceutical composition comprising the crystalline sabcomeline pamoate of claim 2 and at least one pharmaceutically acceptable excipient.
9 . A pharmaceutical composition comprising the crystalline sabcomeline pamoate of claim 3 and at least one pharmaceutically acceptable excipient.