Red blood cell products and the storage of red blood cells in containers free of phthalate plasticizer

Patent metadata

Field	Value
Publication number	US-9993389-B2
Application number	US-201214122847-A
Country	US
Kind code	B2
Filing date	Sep 19, 2012
Priority date	Sep 19, 2011
Publication date	Jun 12, 2018
Grant date	Jun 12, 2018

Abstract

Red blood cell products and compositions are disclosed. The product includes a container made from PVC or a non-PVC material that is substantially free of a phthalate plasticizer but otherwise includes one or more non-phthalate plasticizers or extractable agents. The product includes a RBC concentrate which has been combined with an additive solution for storing the RBCs.

First claim

The invention claimed is:

1. A container for storing red blood cell compositions comprising:
one or more container walls defining an interior chamber, said container wall(s) comprising a polymeric material that includes polyvinyl chloride and that is (a) at least substantially free of phthalate and (b) comprises up to approximately 45%, by weight, of two extractable non-phthalate ester plasticizers that are effective in suppressing hemolysis in red blood cells, wherein one of said plasticizers is a citrate ester and the other of said ester plasticizers is 1, 2-cyclohexane dicarboxylic acid diisononyl ester.

2. The container of claim 1 wherein said citrate ester is n-butyryl-tri-n-hexyl-citrate.

3. The container of claim 1 wherein said citrate ester is acetyltri-n-butyl citrate.

4. The container of claim 1 further comprising at least a third agent.

5. The container of claim 4 wherein said third agent is effective in suppressing hemolysis in red blood cells.

6. The container of claim 1 wherein said citrate and 1, 2-cyclohexane dicarboxylic acid diisononyl esters together comprise between 20%-45%, by weight, of said polymeric material.

7. The container of claim 1 wherein one of said citrate and 1, 2-cyclohexane dicarboxylic acid diisononyl esters together comprises between approximately 5%-60%, by weight, of the combined weight of said citrate and 1, 2-cyclohexane dicarboxylic acid diisononyl ester and, optionally, additional agents.

8. The container of claim 1 wherein said polyvinyl chloride comprises at least approximately 55%, by weight, of said polymeric material.

9. The container of claim 1 wherein said polymeric material comprises approximately 60%-70% polyvinyl chloride, approximately 15%-30% 1, 2-cyclohexane dicarboxylic acid diisononyl ester and approximately 5%-15% citrate ester.

10. The container of claim 9 further comprising approximately 4%-10% epoxidized oil.

11. The container of claim 10 further comprising approximately 0.5%-3.0% of additional co-stabilizers and lubricants.

12. The container of claim 9 wherein said citrate ester is n-butyryl-tri-n-hexyl-citrate.

Assignees

• Fenwal Inc

Inventors

• Radwanski Katherine
• Sandford Craig L
• Min Kyungyoon
• Lynn Daniel
• Mui Tat

Classifications

• A01N1/0226

  Human Necessities · mapped topic

• A61K45/06

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

• A61J1/10 Primary

  Bag-type containers · CPC title

• B32B27/304

  comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF · CPC title

• B32B27/08

  of synthetic resin · CPC title