Crystalline bis- and tris-hydrochloride salt of elamipretide
Disclosed are crystalline forms of the bis- and tris-(hydrochloride) salts of D-Arg-Tyr(2,6-DiMe)-Lys-Phe-NH 2 , which is also known as MTP-131.
1. A process for making a pharmaceutical composition comprising Compound (I),
comprising dissolving a crystalline form of a bis-(hydrochloride) salt of Compound (I);
wherein said crystalline form has peaks in its XRPD pattern at values of two theta (° 2θ) of: 6.4, 9.8, 13.1, 16.9, 19.1, and 29.7.
2. The process of claim 1 , wherein said crystalline form has peaks in its XRPD pattern at values of two theta (°2θ) of: 6.4, 7.0, 7.9, 9.1, 9.8, 10.2, 11.7, 13.1, 16.9, 19.1, 20.6, 24.2, 24.8, 26.3, 27.4, 28.6, and 29.7.
3. A process for making a pharmaceutical composition comprising Compound (I),
comprising dissolving a crystalline form of a tris-(hydrochloride) salt of Compound (I);
wherein said crystalline form has peaks in its XRPD pattern at values of two theta (° 2θ) of: 8.1, 11.5, 15.6, 15.9, 22.1, 23.0, and 27.4.
4. The process of claim 3 , wherein said crystalline form has peaks in its XRPD pattern at values of two theta (° 2θ) of: 8.1, 9.8, 11.0, 11.5, 12.4, 14.9, 15.6, 15.9, 20.1, 21.8, 22.1, 23.0, 27.4, and 28.0.