US 12,077,502 B2
Formulations of T-type calcium channel modulators and methods of use thereof
Kiran Reddy, Boston, MA (US); Margaret S. Lee, Middleton, MA (US); Gabriel Maurice Belfort, Cambridge, MA (US); Sapna Makhija Garad, Malden, MA (US); Mahesh Padval, Cambridge, MA (US); Randall Wagner, Bend, OR (US); and Marion Wittmann, Medford, MA (US)
Assigned to Praxis Precision Medicines, Inc., Boston, MA (US)
Filed by PRAXIS PRECISION MEDICINES, INC., Boston, MA (US)
Filed on Jul. 22, 2022, as Appl. No. 17/871,065.
Application 17/871,065 is a continuation of application No. 17/387,648, filed on Jul. 28, 2021, granted, now 11,427,540.
Application 17/387,648 is a continuation of application No. PCT/US2020/041530, filed on Jul. 10, 2020.
Claims priority of provisional application 62/958,923, filed on Jan. 9, 2020.
Claims priority of provisional application 62/934,820, filed on Nov. 13, 2019.
Claims priority of provisional application 62/873,022, filed on Jul. 11, 2019.
Prior Publication US 2023/0192612 A1, Jun. 22, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. C07D 211/34 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61K 31/445 (2006.01); A61K 47/38 (2006.01); A61P 25/14 (2006.01); C07D 211/26 (2006.01)
CPC C07D 211/34 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2009 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2054 (2013.01); A61K 9/4825 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 31/445 (2013.01); A61K 47/38 (2013.01); A61P 25/14 (2018.01); C07D 211/26 (2013.01); C07B 2200/13 (2013.01)] 35 Claims
 
1. A method of treating an essential tremor in a patient in need thereof, comprising administering to the patient a sufficient amount of an oral dosage form comprising a crystalline anhydrous Form C hydrochloride of Formula (II)

OG Complex Work Unit Chemistry
and a modified-release polymer,
wherein the crystalline anhydrous Form C hydrochloride of Formula (II) is characterized by an X-ray powder diffraction (XRPD) pattern comprising one or more of the following peaks at the diffraction angle 2θ: 26.6±0.2, 16.2±0.2, 17.4±0.2, 22.6±0.2, and 11.5±0.2.