Crystalline phase of (3S.3S′) 4,4′-disulfanediylbis(3-aminobutane 1-sulfonic acid) with L-lysine
The present invention relates to a new crystalline phase of (3S,3S′) 4,4′-disulfanediylbis(3-aminobutane 1-sulfonic acid) (ABSD) with L-lysine and its use, particularly in the pharmaceutical industry, and to processes for preparation thereof. The invention is also directed to pharmaceutical compositions containing at least one crystalline phase of (3S,3S′) 4,4′-disulfanediylbis(3-aminobutane 1-sulfonic acid) (ABSD) with L-lysine and to the therapeutic or prophylactic use of such crystalline phase and compositions comprising the same.
1. The crystalline form (3S,3S′) 4,4′-disulfanediylbis(3-aminobutane 1-sulfonic acid) ABSD with L-lysine, wherein the X-ray diffraction pattern of the crystalline form comprises the following peaks:
Angle (2-Theta)
d value
Intensity
Intensity
°
(Angstrom)
(Count)
(%)
8.8
10.04
1259
100
11.72
7.54
1165
92.6
14.66
6.04
928
73.7
16.92
5.236
299
23.7
18.84
4.706
330
26.2
19.24
4.609
1037
82.4
24.36
3.651
279
22.2
24.88
3.576
352
28
26.525
3.358
794
63.1
wherein the X-ray diffraction pattern is obtained with a Cu Kα anode.
2. A pharmaceutical composition comprising a crystalline form of (3S,3S′) 4,4′-disulfanediylbis(3-aminobutane 1-sulfonic acid) ABSD with L-lysine of claim 1 , in combination with a pharmaceutically acceptable carrier or diluent.
3. A method of treating a subject with high blood pressure heart failure, comprising administering to said subject a therapeutically effective amount of a crystalline form of (3S,3S′) 4,4′-disulfanediylbis(3-aminobutane 1-sulfonic acid) ABSD with L-lysine of claim 1 .