TIANEPTINE SULFATE SALT FORMS AND METHODS OF MAKING AND USING THE SAME
First Claim
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1. 7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide hemisulfate monohydrate, represented by formula (II):
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Abstract
Disclosed herein is a novel sulfate salt of tianeptine with improved properties. Also described herein are novel pharmaceutical compositions comprising tianeptine sulfate salt, methods of making, and related methods of treatment.
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Citations
30 Claims
- 1. 7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide hemisulfate monohydrate, represented by formula (II):
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16. Crystalline 7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide hemisulfate monohydrate, characterized by an X-ray powder diffractogram comprising peaks at about 8.97, about 11.49, about 14.73, about 20.59, about 22.83 and about 23.27 degrees 2-theta.
- 17. A method of making 7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide hemisulfate monohydrate of formula (II):
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23. A controlled release matrix tablet comprising:
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a pharmaceutically effective amount of 7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide hemisulfate monohydrate; and one or more release controlling polymers, wherein the tablet, when orally administered to a patient, provides a mean maximum plasma concentration (Cmax) of 7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide from about 100 ng/mL to about 150 ng/mL. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30)
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Specification