Tianeptine sulfate salt forms and methods of making and using the same
First Claim
Patent Images
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):
3 Assignments
0 Petitions
Accused Products
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.
64 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):
-
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):
-
23. A controlled release matrix tablet comprising:
-
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)
-
Specification