Sodium diacetate crystal and solid dialysis preparation comprising said crystal

Patent metadata

Field	Value
Publication number	US-10822296-B2
Application number	US-201715728102-A
Country	US
Kind code	B2
Filing date	Oct 9, 2017
Priority date	Nov 12, 2013
Publication date	Nov 3, 2020
Grant date	Nov 3, 2020

Abstract

A novel highly stable sodium diacetate crystal, in which the volatilization of acetic acid can be suppressed for a long period. More specifically, a sodium diacetate crystal having a median diameter in the range of 300 to 3000 μm.

First claim

The invention claimed is:

1. A solid dialysis preparation comprising: a crystal of sodium diacetate, which has a median size from 300 to 3000 μm, and has a powder X-ray diffraction pattern having peaks at each of 11.16, 13.65, 15.77, 19.33, 20.19, 20.90, 21.66, 22.38, 23.73, 25.04, 26.28, 27.47, 28.61, 29.80, 30.78, 31.82, 33.83, 34.76, 35.69, 36.60, 38.38 and 39.22° (respectively ±0.2°) within the scanning range of the diffraction angle 28 from 4.0 to 40.0°, and
an electrolyte.

2. A method for preparing a solid dialysis preparation comprising the steps of:
(1) preparing a mixture of sodium chloride, potassium chloride, calcium chloride and magnesium chloride,
(2) adding a solution of potassium chloride and water or a solution or suspension of potassium chloride, sodium acetate and water to the mixture to granulate it,
(3) drying the resulting granules, and
(4) adding glucose and sodium diacetate crystal to the granules to mix them, wherein the sodium diacetate crystal has a median size from 300 to 3000 μm, and has a powder X-ray diffraction pattern having peaks at each of 11.16, 13.65, 15.77, 19.33, 20.19, 20.90, 21.66, 22.38, 23.73, 25.04, 26.28, 27.47, 28.61, 29.80, 30.78, 31.82, 33.83, 34.76, 35.69, 36.60, 38.38 and 39.22° (respectively ±0.2°) within the scanning range of the diffraction angle 28 from 4.0 to 40.0°.

3. A method for preparing a solid dialysis preparation comprising the steps of:
(1) preparing a mixture of sodium chloride, potassium chloride, calcium chloride and magnesium chloride,
(2) adding a solution of potassium chloride and water or a solution or suspension of potassium chloride, sodium acetate and water to the mixture to granulate it,
(3) drying the resulting granules, and
(4) adding glucose and sodium diacetate crystal to the granules to mix them, wherein the sodium diacetate crystal having a powder X-ray diffraction pattern as set forth in Table 1 below.

TABLE 1

Pos
d-spacing
NET intencity
Relative intensity

No.
[°2Th]
[A]
[cts]
[%]

1
11.1605
7.92820
26758.21
33.09

2
13.6518
6.48649
20925.54
25.88

3
15.7738
5.61832
644.63
0.80

4
19.3315
4.59165
5340.13
6.60

5
20.1948
4.39727
274.54
0.34

6
20.8996
4.25054
12043.18
14.89

7
21.6592
4.10315
383.97
0.47

8
22.3778
3.97300
80869.79
100.00

9
23.7331
3.74910
3783.16
4.68

10
25.0379
3.55659
11303.30
13.98

11
26.2780
3.39151
6553.25
8.10

12
27.4715
3.24682
3024.57
3.74

13
28.6062
3.12056
4242.16
5.25

14
29.8049
2.99772
93.49
0.12

15
30.7845
2.90453
4309.01
5.33

16
31.8208
2.81226
5006.29
6.19

17
33.8305
2.64747
3586.83
4.44

18
34.7557
2.57908
14622.64
18.08

19
35.6909
2.51362
2981.54
3.69

20
36.6025
2.45308
534.59
0.66

21
38.3763
2.34367
2938.49
3.63

22
39.2223
2.29505
182.52
0.23

4. A method for preparing a solid dialysis preparation comprising the steps of:
(1) preparing a mixture of sodium chloride, potassium chloride, calcium chloride and magnesium chloride,
(2) adding a solution of potassium chloride and water or a solution or suspension of potassium chloride, sodium acetate and water to the mixture to granulate it,
(3) drying the resulting granules, and
(4) adding glucose and sodium diacetate crystal to the granules to mix them, wherein the sodium diacetate crystal is the crystal having a powder X-ray diffraction pattern as depicted in FIG. 1 .

Assignees

• Fuso Pharmaceutical Ind

Inventors

• Shimamura Hideo
• Murakami Tadataka
• Kurata Yasunori
• Kato Ayaka

Classifications

• A61P7/08

  Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock (artificial tears A61P27/04) · CPC title

• C07B2200/13

  Crystalline forms, e.g. polymorphs · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K33/20

  Elemental chlorine; Inorganic compounds releasing chlorine · CPC title

• C07C51/02

  from salts of carboxylic acids · CPC title