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 drug compositions, containers preventing decay, peptides, etc., can solve the problems of pvdc posing a medical waste problem, and achieve the effects of reducing the risk of pvdc, and ensuring the integrity of the produ

Inactive Publication Date: 2006-07-20
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 incineration. Overwraps comprising at least one clear face, or region or side allow the label of the primary package to be seen. Therefore, a second label is typically not required on the overwrap. In addition, product quality inspection and primary package integrity can also be evaluated. Furthermore, as demonstrated for the first time herein, automation equipment can be used with the clear oxygen barrier laminates, allowing production of very large numbers of packages with high oxygen barrier properties in a short period of time with very little human labor and without the loss of barrier properties. The blood-substitute remains stable at room temperature for periods of two years or more, a significant improvement over previous methods.

Problems solved by technology

PVDC poses a medical waste problem because chlorinated products such as polycyclic aromatic hydrocarbons and hydrochloric acid are generated during incineration.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Synthesis of Stable Polymerized Hb Blood-Substitute

[0103] 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.

[0104] Each blood solution sample was maintained after collection at a temperature of about 2° C. and then strained to remove large aggregates and particles with a 600 mesh screen.

[0105] 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.

[0106] 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”).

[0107] The 0.2% sodium citrate blood solution was then passed, in-series, throu...

example 2

Hemoglobin Blood-Substitute Storage: Foil Overwrap

[0143] 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 to 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 (or 0.015 millimeters) two-sided Saran-coated polyvinyl alcohol layer. The oxygen permeability of these two laminates is less than 0.02 cc per 100 square inch (or 0.02 cc per 645 square centimeters) per 24 hrs per atm at 72° F. (or 22° C.) and 0% humidity. Cryovac P640B is a laminate material comprising a 0.0006 in. (or 0.015 millimeters) 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 per 100 in.2 (or about 8 to 15 cc per 645 square centimeters) per 2...

example 3

Hemoglobin Blood-Substitute Storage: Primary Package

[0145] 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 method for preserving the deoxygenated hemoglobin blood substitute comprises maintaining the deoxygenated blood substitute in an oxygen barrier film overwrap package, wherein at least one face of the overwrap package comprises a transparent laminate material and wherein at least one other face of the overwrap package comprises a foil laminate material. The preserved deoxygenated hemoglobin blood substitute comprises a deoxygenated hemoglobin blood substitute and an oxygen barrier film overwrap package wherein at least one face of the overwrap package comprises a transparent laminate material and wherein at least one other face of the overwrap package comprises a foil laminate material.

Description

RELATED APPLICATIONS [0001] This application is a Continuation of U.S. application Ser. No. 10 / 018,529 filed on Jun. 3, 2002, which is a national stage application of PCT / US00 / 18750 filed on Jul. 7, 2000, which is a Continuation of U.S. patent application Ser. No. 09 / 349,290, filed on Jul. 7, 1999, which is a Continuation-in-Part of U.S. patent application Ser. No. 09 / 173,189, filed on Oct. 14, 1998, which is a Continuation-in-Part of U.S. patent application Ser. No. 08 / 974,658, filed on Nov. 19, 1997 now abandoned, which is a Continuation of U.S. patent application Ser. No. 08 / 471,583, filed Jun. 7, 1995 now issued U.S. Pat. No. 5,691,452, which is a Continuation-in-Part of U.S. patent application Ser. No. 08 / 458,916, filed Jun. 2, 1995 now issued U.S. Pat. No. 5,840,582, which is a Continuation of U.S. patent application Ser. No. 08 / 409,337, filed Mar. 23, 1995 now issued U.S. Pat. No. 5,854,209. The entire teachings of the above-mentioned applications are incorporated herein by r...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/42A61M5/00A01N1/02B65D81/24A61J1/00A61J1/05A61J1/10A61J3/00A61K38/00B32B15/08B32B27/08B65D65/40C07K14/805
CPCA01N1/02A01N1/0263A61J1/05A61K35/00A61K38/42B32B7/02B32B15/08B32B27/08B32B27/18B32B27/304B32B27/32B32B27/36B32B2250/24B32B2264/102B32B2307/412B32B2307/7244B32B2439/80B32B2535/00C07K14/805
Inventor GAWRYL, MARIA S.HOUTCHENS, ROBERT A.LIGHT, WILLIAM R.
Owner OPK BIOTECH
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