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