Platelet protection solution having beta-galactosidase and sialidase inhibitors

Patent metadata

Field	Value
Publication number	US-9788539-B2
Application number	US-201615013204-A
Country	US
Kind code	B2
Filing date	Feb 2, 2016
Priority date	May 17, 2011
Publication date	Oct 17, 2017
Grant date	Oct 17, 2017

Abstract

The present invention relates to a platelet protection solution (PPS) having an amount of one or more β-galactosidase inhibitors with or without an amount of one or more sialidase inhibitors, and optionally one or more glycan-modifying agents; and one or more of PPS components that include a salt, a citrate source, a carbon source, or any combination thereof.

First claim

What is claimed is:

1. A method of storing platelets, wherein isolated platelets are obtained from one or more donors, the method comprises:
a. contacting the isolated platelets with a Platelet Protection Solution (PPS) that comprises:
i. an amount of one or more β-galactosidase inhibitors and an amount of one or more sialidase inhibitors, and optionally an amount of one or more glycan-modifying agents, or a combination thereof; and
ii. PPS components, in a form of salt, consisting essentially of:

a sodium source in an amount ranging between about 100 mM and about 300 mM;
a chloride source in an amount ranging between about 40 mM and about 110 mM;
an acetate source in an amount ranging between about 10 mM and about 50 mM;
a phosphate source in an amount ranging between about 5 mM and about 50 mM;
a potassium source in an amount ranging between about 0.5 mM and about 10 mM; and
a magnesium source in an amount ranging between about 0.5 mM and about 5.0 mM, to thereby obtain a platelet composition.

2. The method of claim 1 , further comprising at least one of the group consisting of:
a. a calcium source in an amount ranging between about 0.1 mM and about 2.5 mM;
b. a glucose source in an amount ranging between about 0.1 mM and about 30 mM;
c. a citrate source in an amount ranging between about 2 mM and about 20 mM; and
d. a combination thereof.

3. The method of claim 1 , wherein the chloride source is present in the amount ranging between about 90 mM and about 110 mM.

4. The method of claim 1 , wherein the one or more sialidase inhibitor is selected from the group consisting of: fetuin; 2,3-dehydro-2-deoxy-N-acetylneuraminic acid (DANA); ethyl (3R,4R,5S)-5-amino-4-acetamido-3-(pentan-3-yloxy)-cyclohex-1-ene-1-carboxylate); (2R,3R,4S)-4-guanidino-3-(prop-1-en-2-ylamino)-2-((1R,2R)-1,2,3-trihydroxypropyl)-3,4-dihydro-2H-pyran-6-carboxylic acid; (4S,5R,6R)-5-acetamido-4-carbamimidamido-6-[(1R,2R)-3-hydroxy-2-methoxypropyl]-5,6-dihydro-4H-pyran-2-carboxylic acid; (1S,2S,3S,4R)-3-[(1S)-1-acetamido-2-ethyl-butyl]-4-(diaminomethylideneamino)-2-hydroxyl-cyclopentane-1-carboxylic acid; a combination thereof; and a pharmaceutically acceptable salt thereof.

5. The method of claim 4 , wherein the sialidase inhibitor is the sodium salt of 2,3-dehydro-2-deoxy-N-acetylneuraminic acid.

6. The method of claim 1 , wherein the one or more β-galactosidase inhibitors is selected from the group consisting of: 1-deoxygalactonojirimycin (DGJ); N-(n -butyl)deoxygalactonojirimycin; N-(n-nonyl)deoxygalactonojirimycin; 5-deoxy-L-arabinose; galactostatin bisulfate; 3′,4′,7-trihydroxyisoflavone; D-ribonolactone; N-octyl-4-epi-β-valienamine; phenylethyl β-D-thiogalactopyranoside; difluorotetrahydropyridothiazinone; 4-aminobenzyl 1-thio β-D-galactopryranoside; a combination thereof and a pharmaceutically acceptable salt thereof.

7. The method of claim 1 , wherein the isolated platelets are stored for a period of about 1to about 21days.

8. The method of claim 1 , wherein the isolated platelets are stored a temperature of between about 2° C. and about 25° C.

9. The method of claim 1 , further comprising cooling the platelet composition to a temperature below room temperature; storing the platelet composition for a period of time; and then rewarming the platelet composition back to room temperature.

10. The method of claim 1 , further comprising treating the population of platelets with the β-galactosidase inhibitor and the sialidase inhibitor, within a time period, wherein the time period is in a range between about 1minute and about 8hours.

11. The method of claim 1 , wherein the PPS is maintained at a pH ranging between about 6.4and about 7.6.

12. The method of claim 1 , wherein the phosphate source is selected from the group consisting of sodium monophosphate, sodium diphosphate, sodium triphosphate, and a combination thereof.

13. The method of claim 2 , wherein the citrate source is selected from the group consisting of monosodium citrate, disodium citrate, trisodium citrate, citric acid, and a combination thereof.

14. The method of claim 1 , wherein the acetate source is selected from the group consisting of sodium acetate, potassium acetate, magnesium acetate, and a combination thereof.

15. The method of claim 1 , wherein the sodium source is selected from the group consisting of sodium chloride, sodium acetate, sodium phosphate, and a combination thereof.

16. The method of claim 1 , wherein the chloride source is selected from the group consisting of sodium chloride, magnesium chloride, potassium chloride, and a combination thereof.

17. The method of claim 1 , wherein the potassium source is selected from the group consisting of potassium chloride, potassium acetate, potassium phosphate, potassium sulfate, and a combination thereof.

18. The method of claim 1 , wherein the magnesium source is selected from the group consisting of magnesium chloride, magnesium sulfate, and a combination thereof.

19. The method of claim 1 , wherein the calcium source is selected from the group consisting of calcium chloride, calcium acetate, and a combination thereof.

20. The method of claim 1 , wherein once the platelet composition is transfused into a recipient, circulation time of platelets is increased, as compared to circulation time of platelets that have not been subjected to Step a).

21. The method of claim 1 , wherein once the platelet composition is transfused into a recipient, platelet clearance of the platelets is reduced, as compared to platelet clearance of platelets that have not been subjected to Step a).

22. The method of claim 2 , wherein the sodium source comprises sodium citrate.

23. The method of claim 2 , wherein the potassium source comprises potassium citrate.

24. The method of claim 2 , wherein the magnesium source comprises magnesium citrate.

25. The method of claim 2 , wherein the calcium source comprises calcium citrate.

Assignees

• Velico Medical Inc
• Brigham & Womens Hospital Inc

Inventors

• Liu Qiyong Peter
• Hoffmeister Karin
• Sackstein Robert

Classifications

• A01N1/0226 Primary

  Human Necessities · mapped topic

• A01N1/126 Primary

  Physiologically active agents, e.g. antioxidants or nutrients · CPC title