Crystalline Form of (R)-7-Chloro-N-(Quinuclidin-3-YL)benzo[B]thiophene-2-Carboxamide Hydrochloride Monohydrate

Abstract

Crystalline Forms I and II of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide hydrochloride monohydrate and compositions, methods of manufacture and therapeutic uses thereof are described.

1 . A crystalline Form II of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide hydrochloride monohydrate, characterized by an x-ray powder diffraction pattern having peaks expressed as 2Θ at:
 i) one or both of 21.16 and 21.38±0.20 degrees when measured against an internal silicon standard; and 
 ii) at least four peaks selected from a group of peaks consisting of: 4.48, 9.00, 13.58, 15.62, 16.48, 19.02, 19.44, 22.46, and 25.00±0.20 degrees when measured against an internal silicon standard. 
 
     
     
         2 . The crystalline Form II of  claim 1 , characterized by an x-ray powder diffraction pattern, wherein at least six peaks are selected from the group of peaks. 
     
     
         3 . The crystalline Form II of  claim 1 , characterized by an x-ray powder diffraction pattern, wherein at least eight peaks are selected from the group of peaks. 
     
     
         4 . The crystalline Form II of  claim 1 , characterized by an x-ray powder diffraction pattern, wherein all of the peaks are selected from the group of peaks. 
     
     
         5 . A pharmaceutical composition comprising the crystalline Form II of  claim 1 . 
     
     
         6 . The pharmaceutical composition of  claim 5 , wherein the pharmaceutical composition is for the treatment of cognitive loss in a subject suffering from Alzheimer's disease. 
     
     
         7 . The pharmaceutical composition of  claim 5 , wherein the pharmaceutical composition is for the treatment of cognitive loss in a subject suffering from Schizophrenia. 
     
     
         8 . The pharmaceutical composition of  claim 5 , wherein the pharmaceutical composition is for the improvement of cognition in a subject suffering from Alzheimer's disease. 
     
     
         9 . The pharmaceutical composition of  claim 5 , wherein the pharmaceutical composition is for the improvement of cognition in a subject suffering from Schizophrenia. 
     
     
         10 . A pharmaceutical composition comprising the crystalline Form II of  claim 2 . 
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein the pharmaceutical composition is for the treatment of cognitive loss in a subject suffering from Alzheimer's disease. 
     
     
         12 . The pharmaceutical composition of  claim 10 , wherein the pharmaceutical composition is for the treatment of cognitive loss in a subject suffering from Schizophrenia. 
     
     
         13 . The pharmaceutical composition of  claim 10 , wherein the pharmaceutical composition is for the improvement of cognition in a subject suffering from Alzheimer's disease. 
     
     
         14 . The pharmaceutical composition of  claim 10 , wherein the pharmaceutical composition is for the improvement of cognition in a subject suffering from Schizophrenia. 
     
     
         15 . A pharmaceutical composition comprising the crystalline Form II of  claim 3 . 
     
     
         16 . The pharmaceutical composition of  claim 15 , wherein the pharmaceutical composition is for the treatment of cognitive loss in a subject suffering from Alzheimer's disease. 
     
     
         17 . The pharmaceutical composition of  claim 15 , wherein the pharmaceutical composition is for the treatment of cognitive loss in a subject suffering from Schizophrenia. 
     
     
         18 . The pharmaceutical composition of  claim 15 , wherein the pharmaceutical composition is for the improvement of cognition in a subject suffering from Alzheimer's disease. 
     
     
         19 . The pharmaceutical composition of  claim 15 , wherein the pharmaceutical composition is for the improvement of cognition in a subject suffering from Schizophrenia. 
     
     
         20 . A pharmaceutical composition comprising the crystalline Form II of  claim 4 . 
     
     
         21 - 44 . (canceled)