Claims for Patent: 6,372,423

Summary for Patent: 6,372,423

Title:	Method for stabilizing platelets
Abstract:	The present invention relates to preparations of functionally active platelets and to a process for stabilizing these functionally active platelets by means of freeze-drying. In particular, a lyophilized or reconstituted platelet composition containing an anticoagulant, a cake forming agent, and an inhibitor of platelet function is disclosed.
Inventor(s):	Braun; Konrad (Ebsdorfergrund, DE)
Assignee:	Dade Behring Marburg GmbH (Marburg, DE)
Application Number:	09/588,497
Patent Claims:	1. A lyophilized platelet-containing composition containing about 10% by weight or less moisture, prepared by lyophilization of an aqueous suspension of platelets in a medium comprising a) an anticoagulant, b) a cake-forming agent, and c) an inhibitor of platelet function, wherein said inhibitor comprises a cationic amphiphilic compound able to traverse the cell membrane, and wherein said anticoagulant and said inhibitor of platelet function are different substances. 2. The composition of claim 1, wherein said anticoagulant is selected from the group consisting of citrate, EDTA, and hirudin. 3. The composition of claim 2 wherein said anticoagulant is hirudin. 4. The composition of claim 3 wherein said hirudin is in a concentration of between 0.1 and 10 units/ml. 5. The composition of claim 1, wherein said platelet inhibitor is selected from the group consisting of chloroquine, hydroxychloroquine, campoquin, quinacrine and procaine. 6. The composition of claim 5, wherein said platelet inhibitor is hydroxychloroquine. 7. The composition of claim 6, wherein said hydroxychloroquine is in a concentration of between 0.1 and 100 g/l. 8. The composition of claim 1, wherein said cake-forming agent is chosen from a protein or a polysaccharide. 9. The composition of claim 1, wherein said cake-forming agent is at least one of serum albumin, mannitol, or polygeline. 10. The composition of claim 9, wherein said serum albumin is in a concentration of between 0.1 and 100 g/l. 11. The composition of claim 9, wherein said serum albumin is in a concentration of between 10 and 70 g/l. 12. The composition of claim 1 further comprising the step of reconstituting the freeze-dried platelets by suspending said platelets in an activation buffer followed by centrifugation. 13. The composition of claim 12, wherein the activation buffer comprises at least one of glucose at a concentration of 1 mg/l to 100 g/l, a magnesium salt at a concentration of 1 mg/l to 100 g/l, a potassium salt at a concentration of 1 mg/l to 100 g/l, and a sodium salt at a concentration of 1 mg/l to 100 g/l. 14. The composition of claim 13, wherein the activation buffer comprises glucose and said glucose is present in a concentration of 0.1 to 5 g/l. 15. A reagent comprising platelets as claimed in claim 12. 16. The reagent as claimed in claim 15 which is used as a standard or control material for platelet function tests. 17. The reagent as claimed in claim 15 which is employed for detecting heparin-induced thrombocytopenia. 18. The composition of claim 14, wherein the activation buffer comprises magnesium chloride in a concentration of from 0.1 to 5 g/l. 19. The composition of claim 14, wherein the activation buffer comprises potassium chloride in a concentration of from 0.1 to 5 g/l. 20. The composition of claim 14, wherein the activation buffer comprises sodium chloride in a concentration of from 0.1 to 5 g/l. 21. A pharmaceutical composition for treating inadequate platelet function in a patient comprising dissolving the freeze-dried platelets as claimed in claim 1 in sterile water for administration to said patient. 22. A pharmaceutical composition comprising the freeze-dried platelets as claimed in claim 1 and a pharmaceutically acceptable carrier.

Details for Patent 6,372,423

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2016-08-24