Stable hemoglobin based composition and method to store same

A - Human Necessities – 61 – K

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Details

A61K 35/18 (2006.01) A61J 1/14 (2006.01) A61K 38/42 (2006.01)

Patent

CA 2067371

The present invention relates to a stable hemoglobin based composition having sufficiently low levels of methemoglobin to effectively function as an oxygen carrying solution upon administration to a patient made by the process comprising: a) adding an oxygenated or deoxygenated form of said blood substitute to an oxygen impermeable package, and b) storing said container at from between 5°C to 45°C for sufficient time to permit the autoreduction of methemoglobin. The stable hemoglobin based composition includes hemoglobin, modified hemoglobin and/or encapsulated hemoglobin. To effectively function as an oxygen carrying solution upon administration to a patient, the stable hemoglobin based solution cannot have greater than about 50% of said hemoglobin based solution in the methemoglobin form but, preferably no more than about 15%. The invention further relates to a method to store a stable oxygen carrying solution according to the above discussed process.

L'invention se rapporte à une composition stable à base d'hémoglobine comportant des niveaux de méthémoglobine suffisamment faibles pour fonctionner efficacement comme solution porteuse d'oxygène quand on l'administre à un malade et qui est produite au moyen d'un processus comprenant: a) l'addition d'une forme oxygénée ou désoxygénée dudit substitut sanguin à un ensemble de conditionnement imperméable oxygéné et, b) le stockage dudit ensemble à une température située entre 5 C et 45 C pendant une période suffisamment longue pour permettre l'autoréduction de la méthémoglobine. La composition stable à base d'hémoglobine comprend de l'hémoglobine, de l'hémoglobine modifiée et/ou encapsulée. Pour fonctionner efficacement comme solution porteuse d'oxygène quand on l'administre à un malade, cette solution stable à base d'hémoglobine ne peut comporter plus de 50 % environ de ladite solution à base d'hémoglobine sous forme de méthémoglobine mais, de préférence, pas plus de 15 % environ. L'invention se rapporte, de plus, à un procédé de stockage d'une solution stable porteuse d'oxygène en rapport avec le processus décrit ci-dessus.

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