Polymorphic form of pridopidine hydrochloride
View Patent ↗This invention relates to a new crystalline form of Pridopidine, a drug substance currently in development for the treatment of Huntington's disease. More specifically the invention provides polymorphic Form II of the Pridopidine hydrochloride salt, a process for the preparation of this polymorphic form, pharmaceutical compositions comprising polymorphic Form II, and methods of uses of this polymorphic form.
1. 4-(3-Methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride salt in a crystalline form, wherein the crystalline form is anhydrous crystalline Form II characterized by an X-ray powder diffraction pattern with reflections corresponding to the d-spacing values 6.1 and 4.9, and 8.9 and 4.1.
2. A pharmaceutical composition comprising a therapeutically effective amount of the 4-(3-methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride salt according to claim 1 , together with one or more adjuvants, excipients, carriers and/or diluents.
3. The pharmaceutical composition of claim 2 , wherein the therapeutically effective amount of 4-(3-methanesulfonyl-phenyl)-1-propyl-piperidine is from about 1 mg to about 500 mg.
4. The pharmaceutical composition of claim 2 , wherein the therapeutically effective amount of 4-(3-methanesulfonyl-phenyl)-1-propyl-piperidine is from about 10 mg to about 100 mg.
5. The pharmaceutical composition of claim 2 , wherein the therapeutically effective amount of 4-(3-methanesulfonyl-phenyl)-1-propyl-piperidine is from about 25 mg to about 50 mg.