US2003105360A1PendingUtilityA1
Form a of fluoxetine hydrochloride
Priority: Jan 31, 2001Filed: Aug 20, 2002Published: Jun 5, 2003
Est. expiryJan 31, 2021(expired)· nominal 20-yr term from priority
A61K 31/138C07C 217/48
60
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Claims
Abstract
The present invention relates to novel polymorphic Form A of fluoxetine hydrochloride.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . Form A of fluoxetine hydrochloride in pure form.
2 . Form A of fluoxetine hydrochloride in pure form characterized by having an x-ray powder diffraction pattern consistent with fluoxetine hydrochloride, and further having a single endotherm as determined by differential scanning calorimetry run at a maximum rate of 1° C. per minute.
3 . Form A of fluoxetine hydrochloride according to claim 2 wherein said single DSC endotherm occurs in the temperature range from about 155° C. to about 160° C.
4 . Form A of fluoxetine hydrochloride according to claim 2 wherein said single DSC endotherm occurs in the temperature range from about 157° C. to about 159° C.
5 . Form A of fluoxetine hydrochloride in pure form characterized by the following single crystallographic parameters:
crystal class
orthorhombic
space group
Pbca (#61)
a (Å)
10.3754 (4)
b (Å)
10.4603 (2)
c (Å)
32.3412 (12)
V (Å 3 )
3510.0 (3)
d calc (g/cm 3 )
1.31
R, R W
0.038, 0.038.
6 . Form A of fluoxetine hydrochloride according to claim 5 further characterized by having an x-ray powder diffraction pattern consistent with fluoxetine hydrochloride, and further characterized by having a single endotherm as determined by differential scanning calorimetry run at a maximum rate of 1° C. per minute.
7 . Form A of fluoxetine hydrochloride according to claim 6 wherein said single DSC endotherm occurs in the temperature range from about 155° C. to about 160° C.
8 . Form A of fluoxetine hydrochloride according to claim 6 wherein said DSC single endotherm occurs in the temperature range from about 157° C. to about 159° C.
9 . Form A of fluoxetine hydrochloride in essentially pure form.
10 . Form A of fluoxetine hydrochloride characterized by having an x-ray powder diffraction pattern consistent with fluoxetine hydrochloride, and further characterized by having at least two endotherms as determined by differential scanning calorimetry run at a maximum rate of 1° C. per minute, provided that the amount of fluoxetine hydrochloride polymorphs other than Form A does not exceed an amount greater than about ten percent (w/w).
11 . Form A of fluoxetine hydrochloride according to claim 10 wherein the peak of said DSC endotherms occurs in the temperature range from about 155° C. to about 160° C.
12 . Form A of fluoxetine hydrochloride according to claim 10 wherein said Form A is further characterized by the following crystallographic parameters:
crystal class
orthorhombic
space group
Pbca (#6 1)
a (Å)
10.3754 (4)
b (Å)
10.4603 (2)
c (Å)
32.3412 (12)
V (Å 3 )
3510.0 (3)
d calc (g/cm 3 )
1.31
R, R W
0.038, 0.038.
13 . Form A of fluoxetine hydrochloride according to claim 12 wherein the peak of said DSC endotherms occurs in the temperature range from about 155° C. to about 160° C.
14 . Form A of fluoxetine hydrochloride form characterized by having an x-ray powder diffraction pattern consistent with fluoxetine hydrochloride, and further characterized by having at least two endotherms as determined by differential scanning calorimetry run at a maximum rate of 1° C. per minute, provided that the amount of fluoxetine hydrochloride polymorphs other than Form A does not exceed an amount greater than about five percent (w/w).
15 . Form A of fluoxetine hydrochloride according to claim 14 wherein the peak of said DSC endotherms occurs in the temperature range from about 155° C. to about 160° C.
16 . Form A of fluoxetine hydrochloride according to claim 14 wherein said Form A is further characterized by the following crystallographic parameters:
crystal class
orthorhombic
space group
Pbca (#61)
a (Å)
10.3754 (4)
b (Å)
10.4603 (2)
c (Å)
32.3412 (12)
V (Å 3 )
3510.0 (3)
d calc (g/cm 3 )
1.31
R, R w
0.038, 0.038.
17 . Form A of fluoxetine hydrochloride according to claim 16 wherein the peak of said DSC endotherms occurs in the temperature range from about 155° C. to about 160° C.
18 . A method for inhibiting serotonin uptake in mammals comprising administering to a mammal requiring increased neurotransmission of serotonin an effective amount of fluoxetine hydrochloride as claimed in any one of claims 1 through 17 .Join the waitlist — get patent alerts
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