SPRAY-DRYING HAEMOGLOBIN

The present invention relates to a method to obtain a dried haemoglobin product, that is stable during extended storage (over years) at ambient temperature (4-30 ~C) and dissolves quickly (within 10 minutes, preferably within 5 minutes, more preferably within 1 minute), easily (without the use of special facilities) and completely (in a clear, dark red solution with minimal particulate contamination). The solution reconstituted from the dried haemoglobin has sufficient low levels of methaemoglobin to effectively function as an oxygen carring solution after reconstitution and upon parenteral administration to a patient. Besides the reconstituted product has a physiologically acceptable formulation (osmolarity: typically 250-350 mosm/1) and has colloid-osmotic activity. The drying process is applicable for haemoglobin, modified haemoglobin, recombinant haemoglobin and/or encapsulated haemoglobin preparations. The process to obtain the dried haemoglobin product is based on spray-granulation with addition of one or more protective additives. Besides, a carrier substance might be used to reduce particulate contamination. To prevent oxidation of haemoglobin, the process and storage can be performed under oxygen free conditions by the use of nitrogen or any other inert gas.