Methods for producing dried storage-stable platelets and compositions obtained thereby

• US 6,221,575 B1
• Filed: 02/06/1998
• Issued: 04/24/2001
• Est. Priority Date: 02/07/1997
• Status: Expired due to Fees

• Current Assignee: Quadrant Drug Delivery Limited (Vectura Group Ltd.)
• Original Assignee: Quadrant Holdings Cambridge Limited
• Inventors: Menys, Valentine, Grandage, Lynda, Phipps, Diana, Roser, Bruce J.
• Primary Examiner(s): Lankford, Jr., Leon B.
• Application Number:
  US09/019,935
• Time in Patent Office: 1,173 Days
• Field of Search: 435/2, 435/374, 436/18, 424/532, 536/123.13
• US Class Current: 435/2
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0221 Freeze-process protecting agents, i.e. substances protecting cells from effects of the physical process, e.g. cryoprotectants, osmolarity regulators like oncotic agents
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

The invention provides methods for drying platelets to obtain compositions which are storage stable over a wide range of temperatures and for an extended period of time. The invention also provides compositions obtained thereby and devices for use therein.

Claims

1. A method for preserving platelets in a form stable at ambient temperature or above, the method comprising:

a) treating a suspension of isolated platelets under conditions effective to introduce into the platelets 5-150 mM of internal trehalose; and

b) drying the platelets in the presence of an amount of external carbohydrate effective to preserve the platelets on drying.

2. The method according to claim 1, wherein the external carbohydrate is trehalose.

3. The method according to claim 1, wherein the internal trehalose concentration is 10-39 mM.

4. The method according to claim 1, wherein the internal trehalose concentration is 20-60 mM.

5. The method according to claim 2, wherein the external trehalose concentration is 1-30%.

6. The method according to claim 2, wherein the external trehalose is in a drying buffer.

7. The method according to claim 6, wherein the drying buffer further comprises serum albumin.

10. The method of claim 1, wherein step b) comprises vacuum drying the platelets.

11. The method of claim 1, wherein step a) comprises electropermeabilisation of the platelets.

8. A composition comprising dried platelets comprising 5-150 mM of internal trehalose and external carbohydrate.

9. A storage-stable pack comprising the composition of claim 8.