Preserving a hemoglobin blood substitute with a transparent overwrap

a technology of hemoglobin blood substitute and transparent overwrap, which is applied in the direction of synthetic resin layered products, peptides, drug compositions, etc., can solve the problems of medical waste caused by pvdc, and achieve the effects of reducing the risk of contamination, and increasing the degree of purity

Inactive Publication Date: 2002-09-12
OPK BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

0013] The advantages of this invention are numerous. One advantage is that the hemoglobin stored according to the methods of this invention has a greater degree of purity and longer shelf-life. High barrier overwraps provide an addition level of product quality even when high barrier primary packaging is employed. In addition, the transparent high barrier overwraps of the present invention provide extremely high oxygen and water vapor barrier properties but have no saran (polyvinylidene chloride, PVDC) layer. PVDC poses a medical waste problem because chlorinated products such as polycyclic aromatic hydrocarbons and hydrochloric acid are generated during

Problems solved by technology

PVDC poses a medical waste problem because chlorinated products such as polycycl

Method used

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  • Preserving a hemoglobin blood substitute with a transparent overwrap

Examples

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example 1

Synthesis of Stable Polymerized Hb Blood-Substitute

[0102] As described in U.S. Pat. No. 5,296,465, samples of bovine whole blood were collected, mixed with a sodium citrate anticoagulant to form a blood solution.

[0103] Each blood solution sample was maintained after collection at a temperature of about 2.degree. C. and then strained to remove large aggregates and particles with a 600 mesh screen.

[0104] Prior to pooling, the penicillin level in each blood solution sample was assayed with an assay kit purchased from Difco, Detroit, Mich. using the method entitled "Rapid Detection of Penicillin in Milk" to ensure that penicillin levels in the blood solutions were <0.008 units / ml.

[0105] The blood solution samples were then pooled and mixed with depyrogenated aqueous sodium citrate solution to form a 0.2% by weight solution of sodium citrate in bovine whole blood (hereafter "0.2% sodium citrate blood solution").

[0106] The 0.2% sodium citrate blood solution was then passed, in-series, thr...

example 2

Hemoglobin Blood-Substitute Storage: Foil Overwrap

[0142] The hemoglobin blood-substitute, as prepared in Example 1, packaged in a 600 mL Stericon package, was overwrapped in a foil laminate package (KAPAK 50303, referred below as "foil"), Cryovac BYV200 or Cryovac P640B package. KAPAK 50303 is foil laminate container wherein the foil layer is aluminum foil. Cryovac BYV200 is a laminate containing a 0.0006 inch two-sided Saran-coated polyvinyl alcohol layer. The oxygen permeability of these two laminates is less than 0.02 cc / 100 square inch / 24 hrs / atm / 72.degree. F. / 0% humidity. Cryovac P640B is a laminate material comprising a 0.0006 in. Saran-coated, biaxially-oriented Nylon layer, an adhesive and a linear low density polyethylene sealant layer. The oxygen permeability of the material is about 8 to 15 cc / 100 sq in / 24 hours / atm / 72.degree. F. / 0% humidity. The packaged blood substitutes were maintained at room temperature for about 418 days with periodic sampling of the concentration a...

example 3

Hemoglobin Blood-Substitute Storage: Primary Package

[0144] The hemoglobin blood-substitute, as prepared in Example 1 was packaged in an oxygen barrier primary package (E-13135 and E13242, American National Can). The construction of the primary package is discussed in detail above. The primary package is a laminate material comprising a medium density polyethylene layer, ethylene vinyl alcohol / nylon layer, and linear low density polyethylene sealant layer.

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Abstract

The invention relates to a method for preserving the stability of a hemoglobin blood substitute comprising maintaining the hemoglobin blood substitute in an atmosphere substantially free of oxygen. The invention also involves a method for producing a stable polymerized hemoglobin blood-substitute from blood. The method of this invention includes mixing blood with an anticoagulent to form a blood solution, washing the red blood cells in the blood solution and then separating the washed red blood cells from the white blood cells. This method also includes disrupting the red blood cells to release hemoglobin and form a hemoglobin solution, which is then treated by high performance liquid chromatography to form a hemoglobin eluate. The hemoglobin eluate is then deoxygenated, contacted with a first sulfhydryl compound to form an oxidation-stabilized deoxygenated hemoglobin solution, and mixed with a cross-linking agent to form a polymerization reaction mixture, which is then polymerized. The polymerized hemoglobin solution is then diafiltered with a physiologic solution and with a sulfhydryl compound, whereby the polymerized hemoglobin solution is made physiologically acceptable, and whereby the sulfhydryl compound scavenges oxygen, to form a stable polymerized hemoglobin blood-substitute, which is then packaged and stored in an atmosphere substantially free of oxygen.

Description

RELATED APPLICATIONS[0001] This application is a continuation of U.S. Ser. No. 09 / 348,881, filed on Jul. 7, 1999, which is a continuation-in-part of U.S. Ser. No. 09 / 173,189, filed on Oct. 14, 1998, which is a continuation-in-part of U.S. Ser. No. 08 / 974,658, filed on Nov. 19, 1997, now abandoned, which is a continuation of U.S. Ser. No. 08 / 471,583, filed on Jun. 7, 1995, now issued U.S. Pat. No. 5,691,452, which is a continuation-in-part of U.S. Ser. No. 08 / 458,916, filed on Jun. 2, 1995, now issued U.S. Pat. No. 5,840,582, which is a continuation of U.S. Ser. No. 08 / 409,337, filed on Mar. 23, 1995, now issued U.S. Pat. No. 5,854,209. The entire teachings of the above applications are incorporated herein by reference.BACKGROUND OF THE INVENTION[0002] There exists a need for a blood-substitute to treat or prevent hypoxia resulting from blood loss (e.g, from acute hemorrhage or during surgical operations), resulting from anemia (e.g., pernicious anemia or sickle cell anemia), or resu...

Claims

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Application Information

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IPC IPC(8): A01N1/02A61J1/00A61J1/05A61J1/10A61K35/14A61K35/18A61K38/00A61K38/16A61K38/42A61M1/02A61P7/00A61P7/06B32B15/08B32B27/08B32B27/32C07K14/805
CPCA01N1/02B32B2307/7244A61J1/05A61J1/10A61K38/42A61M1/0272B32B15/08B32B27/08B32B27/32C07K14/805B32B27/306B32B15/082B32B2439/80B32B1/02B32B2307/412B32B37/153A01N1/0263A61P7/00A61P7/06A61K38/00
Inventor GAWRYL, MARIA S.HOUTCHENS, ROBERT A.LIGHT, WILLIAM R.
Owner OPK BIOTECH
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