Solid state form of centanafadine HCL and process for preparation thereof
The present disclosure encompasses a solid state form of Centanafadine HCl, processes for preparation thereof, and pharmaceutical compositions thereof.
1 . A crystalline form CN1 of Centanafadine HCl, which is characterized by data selected from one or more of the following:
i) an XRPD pattern having peaks at 12.6, 13.6, 18.7, 24.6 and 31.5 degrees 2-theta±0.2 degrees 2-theta;
ii) an XRPD pattern as depicted in FIG. 1 ;
iii) an XRPD pattern as depicted in FIG. 2 ;
iv) a solid state 13 C-NMR spectrum with peaks at 11.1, 23.4, 29.4, 30.5, 128.5 and 131.8 ppm±0.2 ppm;
v) a solid state 13 C-NMR spectrum having the following chemical shift absolute differences from a peak at 47.9 ppm±2 ppm of 36.8, 24.5, 18.5, 17.4, 80.6 and 83.9 ppm±0.1 ppm; or
vi) a solid state 13 C-NMR spectrum substantially as depicted in FIG. 3 a.
2 . The crystalline form of Centanafadine HCl according to claim 1 , which is characterized by an XRPD pattern having peaks at 12.6, 13.6, 18.7, 24.6 and 31.5 degrees 2-theta±0.2 degrees 2-theta, and also having one, two, three or four additional peaks selected from 23.4, 27.7, 29.4 and 30.9 degrees 2-theta±0.2 degrees 2-theta.
3 . A pharmaceutical composition comprising the crystalline form according to claim 1 .
4 . A pharmaceutical formulation comprising the crystalline form according to claim 1 , and at least one pharmaceutically acceptable excipient.
5 . A medicament comprising the crystalline form according to claim 1 .
6 . A method of treating attention-deficit hyperactivity disorder (ADHD), comprising administering a therapeutically effective amount of the crystalline form according to claim 1 to a subject suffering from said disorder.
7 . A pharmaceutical composition comprising a crystalline form according to claim 2 .
8 . A pharmaceutical formulation comprising a crystalline form according to claim 2 and at least one pharmaceutically acceptable excipient.
9 . A medicament comprising the crystalline form according to claim 2 .
10 . A method of treating attention-deficit hyperactivity disorder (ADHD), comprising administering a therapeutically effective amount of the crystalline form according to claim 2 to a subject suffering from said disorder.
11 . A method of treating attention-deficit hyperactivity disorder (ADHD), comprising administering a therapeutically effective amount of the pharmaceutical composition of claim 3 to a subject suffering from said disorder.
12 . A method of treating attention-deficit hyperactivity disorder (ADHD), comprising administering a therapeutically effective amount of the pharmaceutical formulation according to claim 4 to a subject suffering from said disorder.