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AssigneeNorthfield Laboratories, Inc.
InventorsRichard E. DeWoskin, Marc D. Doubleday
Estimating the term…
A process is disclosed for the preparation of an essentially tetramer-free, substantially stroma-free, polymerized, pyridoxylated hemoglobin. Also disclosed is an essentially tetramer-free, substantially stroma-free, polymerized, pyridoxylated hemoglobin product capable of being infused into human patients in an amount of up to about 5 liters.
An aqueous solution of pyridoxylated, polymerized hemoglobin, where the hemoglobin solution is capable of being infused into a human patient in an amount of up to about 1.5 liters without causing a decrease in kidney performance.
A process for preparing a solution of pyridoxylated, polymerized hemoglobin capable of being infused into a human patient in an amount of up to about 3 liters, comprising:
A method of transfusing a human patient in need of a transfustion, comprising administering to the patient up to about 1.5 liters of a pyridoxylated, polymerized hemoglobin solution.
A method of transfusing a human patient in need of a transfustion, comprising administering to the patient up to about 3.0 liters of a pyridoxylated, polymerized hemoglobin solution.
A method of transfusing a human patient in need of a transfustion, comprising administering to the patient up to about 5.0 liters of a pyridoxylated, polymerized hemoglobin solution.
Dependencies are inferred from the claim text.
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Porphyrin- or corrin-ring-containing peptides: haemoglobins; Myoglobins
Drugs for disorders of the blood or the extracellular fluid
Drugs for disorders of the blood or the extracellular fluid: antianaemics
Drugs for disorders of the blood or the extracellular fluid: plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for…
Term end not estimated
1. Field of the Invention
This invention relates to methods and apparatus for preparing red blood cell substitute products, i.e., hemoglobin products. It further relates to an acellular red blood cell substitute comprising an essentially tetramer-free, cross linked, polymerized, pyridoxylated hemoglobin solution which is free of stromal contaminants.
2. Description of Related Art
FIG. 1 is a schematic diagram depicting the portion of the process and equipment used to result in a deoxygenated hemoglobin solution prepared for pyridoxylation and polymerization.
FIG. 2 is a schematic diagram depicting the portion of the process and apparatus beginning with pyridoxylation and polymerization and resulting in a deoxygenated, purified, pyridoxylated, polymerized hemoglobin product and the portion of the process and apparatus used to formulate the final hemoglobin product having physiological levels of electrolytes.
FIG. 3 is an HPLC tracing of polymerized material after glycine treatment prior to purification. Polymerized product is indicated by peaks at retention times (RT) 15.57, 16.08, 17.00, and 18.19. Tetramic material is indicated by peaks at RT 19.88 and 20.51. Polymer is 76.2% of this material.
The present invention concerns an acellular red blood cell substitute comprising an essentially tetramer-free, cross-linked, polymerized, pyridoxylated hemoglobin which is substantially free of stroma, stromal contaminants and other contaminants.
As used herein, the term “cross-linked” means the chemical emplacement of molecular “bridges” onto or into a molecule, or between molecules with the purpose of altering the shape, size, function or physical characteristics of the molecule. Cross-linked molecules may be polymerized or non-polymerized, i.e., cross-linked molecules may be tetrameric.
As used herein, the term “tetramer” refers to hemoglobin molecules having a molecular weight of about 64Kd; that is, the term refers to both native and intramolecularly crosslinked hemoglobin molecules.